An Analysis on leveraging the patent cliff with drug sales worth USD

251 billion going off-patent and analysis of different drug pricing

methodologies for Indian Generic Pharmaceutical companies.

Study conducted by Department of Pharmaceuticals

Ministry of Chemicals & Fertilizers
Government of India
AUGUST, 2023
Disclaimer for Report:

Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India had
engaged Biovantis Healthcare Private Limited (Biovantis) to prepare this report, which is based on
independent research and analysis done by Biovantis. All rights are reserved. All copyright in this
report and related work is solely and exclusively owned by Department of Pharmaceuticals (DoP) and
Biovantis Healthcare Private Limited. The report leveraged from primary and secondary data as well
as information drawn from various sources such as articles (peer reviews & general) and interviews
with leading experts. The views expressed by experts and Key opinion leaders are personal and should
not be ascribed to the organisations that they are professionally engaged with. This report is for
information purposes only. While due care has been taken during the compilation of this report to
ensure that the information is accurate to the best of Biovantis’ and DoP’s knowledge and belief, the
content is not to be construed in any manner whatsoever as a substitute for professional advice.
Biovantis and DoP neither recommend nor endorse any specific products or services that may have
been mentioned in this report and nor do they assume any liability or responsibility for the outcome
of decisions taken as a result of any reliance placed in this report. Neither Biovantis nor DoP shall be
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user due to any reliance placed or guidance taken from any portion of this report.

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 TABLE OF CONTENTS

1. INTRODUCTION…………………..…………………………………………………………………………………….5

1.1. Background

1.2. Study Assumptions and Study Definition

1.3. Base Estimates and Working

2. RESEARCH FRAMEWORK…………………………………………………………………………………………..8

2.1. Primary Research

2.2. Secondary Research

2.3. Data Triangulation

2.4. Insight Generation

3. EXECUTIVE SUMMARY…………………………………………………………………………………………….10

3.1 Definition and Explanation of Patent Cliff

3.2 Distinction between Patent Protection and Regulatory Exclusivity

3.3 Global Impact and Implications of Impending Patent Cliff of 2022-2030

3.4 Patent Expirations by numbers (Patent cliff 2020-2030)

3.5 Major Blockbuster drug Patent Expirations during the Patent cliff 2020-2030

3.6 Cost Savings from generic drug prescription:

3.7 Shift from Chemical generics to Biosimilars by 2030

3.8 Classification of blockbuster drugs going off-patent by 2030

3.9 US Patent Number/s and Patent Expiry Dates of Blockbuster Drugs

3.10 Ease of Technology transfer and Potential Indian generic players that can
benefit from Patent Cliff

4. ASSESSMENT OF BLOCKBUSTER DRUGS GOING OFF-PATENT…………..………………31

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5. GENERIC PHARMACEUTICAL INDUSTRY ………………………………………………………….56
5.1 Overview and Market Size of Global Pharmaceutical Industry

5.2 Indian Generic Pharmaceutical Industry

5.4 PESTEL Analysis of Indian Pharmaceutical Industry

5.4 SWOT Analysis of Indian Pharmaceutical Industry

5.5 Major Pharmaceutical Players in the Indian Market

5.6 Major Therapeutic Opportunities for Indian Generic companies

5.6.1. Cardiovascular Diseases

5.6.2. Central Nervous System Diseases

5.6.3. Oncology

5.6.4. Respiratory disease

5.6.5. Diabetes

5.6.6 Autoimmune Diseases

5.7 Competitive Landscape for Indian Generic companies

6. CHALLENGES FOR INDIAN GENERIC COMPANIES ………………………………………………………… 83

6.1 Overview

6.1.1 Complex Intellectual Property Landscape

6.1.2 Lack of Research and Development and Innovation

6.1.3 Regulatory Compliance

6.1.4 Manufacturing and Quality Issues

6.1.5 Competition and Market Dynamics

7. WAY FORWARD FOR INDIAN GENERIC COMPANIES TO MITIGATE BUSINESS RISKS ………..…...86

8. WAY FORWARD FOR INDIAN GENERIC COMPANIES TO MITIGATE QUALITY RISKS………..….…...90

9. PRICING STRATEGIES FOR INDIAN GENERIC COMPANIES ………………….……………….……93

10. REFERENCES …………………………………………………………………………….….…100

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1. INTRODUCTION
1.1. Background
Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers is nodal agency for
the scheme “Strengthening of Pharmaceutical Industry (SPI)", with a total financial outlay of
Rs.500 Cr for the period from FY 21-22 to FY 25-26. The scheme aims to address the rising
demand in terms of support required to existing Pharma clusters and MSMEs across the country
to improve their productivity, quality and sustainability.
The objectives of the Scheme “Strengthening of Pharmaceutical Industry (SPI)” are to
strengthen the existing infrastructure facilities in order to make India a global leader in the
Pharmaceutical Sector. Under the Scheme, there is a provision for the financial assistance to
pharma clusters for creation of Common Facilities.
Further, in order to upgrade the production facilities of SMEs and MSMEs so as to meet the
national and international regulatory standards (WHO-GMP or Schedule-M), the incentives like
interest subvention or capital subsidy on their capital loans is being provided to facilitate the
growth in volumes as well as in quality of drugs in India.
The SPI Scheme of Department of Pharmaceutical has broadly 3 components / sub-schemes:
Assistance to Pharmaceutical Industry for Common Facilities (APICF): To strengthen the
existing pharmaceutical clusters’ capacity for their sustained growth by creating common
facilities. Under the API-CF sub-scheme, support for clusters for creation of common facilities
with the focus on R&D Labs, Testing Laboratories, Effluent Treatment Plants, Logistic Centres
and Training Centres in this order of priority with an outlay of 178 Cr for the scheme period of
five years is proposed.
Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS): To facilitate Micro,
Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and
international regulatory standards. Under the PTUAS sub-scheme, support for about SME
Industries is proposed, either through up to maximum of 5% per annum (6% in case of units
owned and managed by SC/STs) of interest subvention or through Credit linked Capital subsidy
of 10%. In both the cases, the loan supported under this is to a limit of 10 Crores and the eligible
components of the loan has been listed out in the scheme guidelines. An outlay of 300 Cr has
been earmarked for sub scheme for the scheme period of five years.

Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS): To

facilitate growth and development of Pharmaceutical and Medical Devices Sectors through
study/survey reports, awareness programs, creation of database, and promotion of industry.
Under the PMPDS sub-scheme, knowledge and awareness about the Pharmaceutical and
MedTech Industry will be promoted. This will be done by undertaking studies, building
databases and bringing industry leaders, academia and policy makers together to share their
knowledge and experience for overall development of the Pharma and Medical Devices sector.
An outlay of 21.5 Cr has been earmarked for the sub scheme for the scheme period of five
years. It is expected that the units supported under this scheme will act as Demonstration Firms

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for the pharma clusters and MSE Pharma Industries, to develop on quality and technology
upgradation fronts.
In the years between 2022-30, the pharmaceutical sector in India will undergo landmark
changes as a number of drugs are expected to go off-patent and provide an opportunity for the
entry of generic products. Expiry of patents is very promising for the Indian generic drug market
as it is expected to expand and grow further with inclusion of these new drugs. With ongoing
developments, India has started focusing on self-reliance at a large scale. Hence, it is imperative
to identify these drugs beforehand, draft and implement strategies which help in their timely
entry into the market by promoting generic drug manufacturing. Under the same PMPDS
Scheme, the department took an initiative to conduct an independent study on analysis on
leveraging the impending patent cliff, with drug sales worth USD 251 billion going off-patent
and to analyse the different drug pricing methodologies particularly w.r.t to these patented
drugs going off-patent.
1.2. Study Assumptions and Study Definition

Study Assumptions:
● The study assumed that the information available on various secondary sources of
data regarding the drugs going off-patent and their sales worth USD 251 billion is
accurate and reliable.
● It also assumed that the patent expiration dates, historical pricing data and
associated sales data that were publicly available were reliable to be accessed for
analysis.

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 ● The study assumed that the drug pricing methodologies under analysis were
representative of the broader pharmaceutical industry and did not represent any
specific company’s pricing policies.
Study Definition: The assessment study, "An Analysis on Leveraging the Patent Cliff
with Drug Sales Worth USD 251 Billion Going Off-Patent and to Analyse Different Drug
Pricing Methodologies," aimed to investigate the implications of the patent cliff on the
Indian pharmaceutical industry and analyse various drug pricing methodologies which
should be opted by Indian generic pharmaceutical companies to capture the maximum
market share created as a result of this patent Cliff.
The study encompassed the following key components:
● Identification and Analysis of Drugs Going Off-Patent: The study was commissioned
to identify a comprehensive list of drugs of 20 plus drugs with sales worth USD 251
billion that were approaching or have recently reached their patent expiration
dates. The analysis considered the major US patents for the uniformity of analysis
and the potential impact of their patent expiry on the pharmaceutical market,
including changes in market dynamics, competition, and pricing due to the entry of
Indian Generic Pharmaceutical Players.
● Assessment of the Patent Cliff: The study examined the patent cliff phenomenon,
which refers to a period when a significant number of drugs lose their patent
protection, leading to increased competition from generic alternatives. The
assessment also explored the magnitude of the patent cliff and its implications for
pharmaceutical companies, healthcare providers, and consumers.
● Evaluation of Drug Pricing Methodologies: The study analysed the different drug
pricing methodologies employed by pharmaceutical companies. This analysis also
encompassed a range of factors, such as cost-based pricing, value-based pricing,
market-based pricing, and other relevant strategies.
● Recommendations and Implications: Based on the findings of the study, the
assessment agency has provided recommendations for Indian Generic
pharmaceutical companies, policymakers, and other stakeholders regarding
leveraging the patent cliff and selecting appropriate drug. The implications of the
study's findings for the industry, healthcare systems, and consumers will also be
discussed.
1.3. Base Estimates and Working
Base Estimate:
● Duration: The study was estimated to be conducted over a period of 6 months.
● Resources: The study required a team of researchers, analysts, and subject matter
experts with expertise in the pharmaceutical industry, drug pricing, patent
expiration, and market analysis. The team allocated by BHPL included experienced

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 individuals in the above-mentioned areas along with skills in data analysis, research
methodology, and report writing in Pharmaceutical Sector.
● Data Sources: The study primarily relied on publicly available data sources such as
patent databases, industry reports, regulatory filings, and scholarly articles.
Additionally, interviews with industry experts and key stakeholders were conducted
to gather insights and opinions.
Working Approach:
The study employed a combination of quantitative and qualitative research methods, including
data analysis, literature review, industry perspective and expert opinions. The aim is to provide
a comprehensive assessment of the patent cliff's impact and different drug pricing
methodologies to support informed decision-making in the pharmaceutical industry.

2. RESEARCH FRAMEWORK
2.1. Primary Research
The study primarily included secondary research. However, some discussions were conducted
with the experts from the pharmaceutical industry, patents, and drug pricing to gather diverse
perspectives.
2.2. Secondary Research
Reputable and reliable sources of information relevant to the research objectives were
identified and utilized in secondary data collection. A Systematic literature review was
conducted to gather relevant academic articles, research studies, case studies related to the
patent cliff and drug pricing methodologies and scholarly publications. These sources included,
but were not limited to:
● Academic databases: Databases like PubMed, Scopus, or Google Scholar to access
scholarly articles and research studies related to the patent cliff, drug pricing
methodologies, and pharmaceutical industry dynamics.
● Industry reports: Reports published by market research firms, industry associations, or
consulting agencies that provide insights on the pharmaceutical industry, latest market
trends, and drug pricing strategies.
● Regulatory databases: Access regulatory databases such as the U.S. Food and Drug
Administration (FDA) or European Medicines Agency (EMA) databases to gather
information on drug approvals, patent expirations, and regulatory policies.
● Government Patents databases: Patent databases like the United States Patent and
Trademark Office (USPTO) or the World Intellectual Property Organization (WIPO)
database to identify relevant patents, expiration dates, and associated drug sales.
● Subscription based patent Database: Drug Patent watch

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 ● Government publications: Reports and publications from governmental bodies such as
health departments or regulatory agencies that may provide insights into drug pricing
policies and their implications.
2.3. Data Triangulation
The data was validated by cross-referencing the information obtained from different sources.
The quantitative and qualitative data gathered from various sources, including primary and
secondary sources was combined to enhance the robustness of the analysis. a result of this
holistic understanding of the data in the key insights were derived from the triangulation
process.

2.4. Insight Generation

The key findings were interpreted within the broader context of the pharmaceutical industry,
market dynamics, patent regime, regulatory environment, and relevant economic factors to
synthesize insights. Different drug pricing methodologies were analysed in the study to identify
the strengths, weaknesses, advantages, and disadvantages of each methodology. Further,
different strategies were assessed for their suitability for leveraging the patent cliff effectively
and their potential impact on market dynamics and profitability for the generic pharmaceutical
companies in India. The generated insights were validated by checking their alignment with the
data, analysis, and research objectives. It was ensured that the generated insights were logical,
supported by evidence, and consistent across different sources and methods used in the study.

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 EXECUTIVE SUMMARY

3. EXECUTIVE SUMMARY
3.1 Definition and Explanation
The approval process for new innovative drugs and for follow-on drugs or generics is very
different. There are three basic mechanisms for small-molecule drugs. New small-molecule
drugs are approved by submitting a New Drug Application (NDA) to the FDA. Generic drugs are
approved through an Abbreviated New Drug Application (ANDA) process, and there is a hybrid
process named by its regulatory section, 505(b)(2), which applies to modifications of new drugs
which are neither novel, nor generics. For biologics, new drugs and followers are approved by
Biologics License Applications (BLAs). New biologic drugs are approved through section 351(a),
and follower biosimilars are approved through section 351(k) of the US Public Health Act.
Generic product development cost specially for small molecule drugs is substantially lower than
the costs of initial research and development. So, once a drug is known to be safe and effective,
it can generally be reverse-engineered without much difficulty. Without market protections for
innovators, the generic manufacturers would be able to produce copies of innovative drugs and
sell them at a fraction of the cost of innovators, reflecting their greatly-reduced research and
development costs. For this reason, patent protection and regulatory exclusivity are a kind of
reward for innovators for engaging in research areas with a high risk of failure. In the absence
of protections companies, their employees, and their investors would lack the motivations to
spend years and hundreds of millions of dollars researching and developing innovative new
drugs.

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Patents across various industries, including drugs, arise from the intellectual property spurred
from the innovation to raise the rewards for discovery, which also grants a monopoly in
discovery. Patents foster innovation as they provide the manufacturer with the opportunity
for a temporary monopoly for a period of market exclusivity. The term of drug patents varies.
The basic term for a patent is 20 years from the date of patent filing, which generally occurs
several years before a drug is approved. This means that drugs may have 6-12 years of patent-
protected sales after launch. There are conditions under which drug patents can be extended,
for example to compensate for time spent waiting for Food and Drug Agency (FDA) review, or
for responding to an FDA request for paediatric testing.
Consequently, the expiry of patents decreases the overall market returns of individual
pharmaceuticals due to post-expiration reduction in marketing share. The term "patent cliff"
refers to a significant event in the pharmaceutical industry when a large number of patents for
branded or innovator drugs are set to expire within a relatively short period, typically within a
few years. This expiration of patents creates an opportunity for generic drug manufacturers to
enter the market and produce lower-cost versions of the previously patented drugs. When a
drug is initially developed and approved, the pharmaceutical company typically obtains a
patent that grants them exclusive rights to manufacture and sell the drug for a specified period,
usually around 20 years. During this time, the company can charge higher prices to recoup the
costs of research, development, and marketing. This exclusivity allows the company to enjoy a
monopoly on the drug, without facing competition from generic alternatives.
However, once the patent nears expiration, other pharmaceutical companies can apply for
approval to produce and sell generic versions of the drug. These generic drugs contain the same
active pharmaceutical ingredients as the innovator drugs and are typically sold at lower prices.
As a result, when the patent expires and the market becomes open to generic competition,
sales of the branded drugs often experience a significant decline.
The term "patent cliff" is used to describe this period of patent expirations and the subsequent
revenue loss experienced by pharmaceutical companies as their drugs face generic
competition. It is called a "cliff" because the revenue drop-off can be steep and sudden, as
multiple drugs lose their patent protection simultaneously. The patent cliff brings both
challenges and opportunities for the pharmaceutical industry. While it can lead to a decline in
sales and profitability for innovator companies with drugs going off-patent, it also creates
opportunities for generic manufacturers to enter the market, increase competition, and
provide more affordable options to healthcare providers and patients. It also incentivizes the
innovation as pharmaceutical companies strive to develop new drugs and maintain their
competitive advantage in the market by bringing new drugs to market.
The period from 2023 to 2030 is projected to witness a significant patent cliff in the
pharmaceutical industry, with numerous high-revenue drugs facing patent expirations
(Exhibit 1). This timeframe marks a critical phase for pharmaceutical companies as they
navigate the challenges and opportunities associated with the expiration of these patents. The
specific drugs and their corresponding patent expiration dates may vary, but it is expected that

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several blockbuster drugs will be affected during this period. The patent cliff from 2023 to 2030
will likely result in increased competition from generic drug manufacturers entering the market.
Exhibit 1: Annual Sales figures of Top Blockbuster drugs in USD Billion in year 2022

Source: Product Sales data and CAGR as per Global data/ Statista/Company’s Annual reports

Pharmaceutical companies impacted by the patent cliff try to adapt their strategies to mitigate
the expected revenue losses by launching new drugs to replace the lost sales, seek partnerships
or acquisitions, invest in research and development, or explore other revenue streams such as
biologics, biosimilars and specialty drugs.

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For healthcare systems and patients, the patent cliff can be beneficial as it expands access to
more affordable medications. The availability of generic versions of previously expensive drugs
can help reduce healthcare costs and improve affordability for patients.

3.2 Distinction between Patent Protection and Regulatory Exclusivity

Drug patents are typically sought for the compound itself if the product is a new chemical entity
that is not already approved and patented in the United States. However, patents can also be
granted for the process (methodology, equipment) used to manufacture that compound, the
formulation (dosage form) of the compound, or the method of use of the compound. In
addition to protections derived from patents, the USFDA and some other regulators may grant
market exclusivity to drugs meeting specific conditions.

The motivation to grant exclusivity is to foster innovation and to promote the development of
drugs for applications that might otherwise offer insufficient motivation. Patents and
regulatory exclusivity work in a similar fashion but are distinct from one another and governed
by different statutes. Patents are a property right granted by the U.S. Patent and Trademark
Office (USPTO). They may be enforced at any time and can encompass a wide range of claims.

Regulatory exclusivity on the other hand is granted by the U.S. Food and Drug Administration
and similar regulatory bodies in other countries, which prevents the regulatory approval of
competitor drugs. While some regulatory exclusivities such as paediatric clinical trial exclusivity
are attached to the end of patents, in most cases patents and regulatory exclusivity are
independent. For example, patents can be asserted against drugs which are in development,
against the drugs for which approval is sought, or after a drug launches. By contrast, regulatory
exclusivity tends to affect only drug approvals.

In US, the market exclusivity and patent terms for drugs are governed by The Drug Price
Competition and Patent Term Restoration Act of 1984, or more commonly known at the Hatch-
Waxman Act. This act is held as a federal law aligned with the United States Food and Drug
Administration (FDA) drug approval processes. The act aims to strike a balance between protecting
innovation while increasing competition, by using exclusivities and patent extensions to protect
innovation and creating the modern abbreviated new drug application (ANDA) approval pathway to
facilitate market entry of lower-cost generics. Following the formation of this amendment, the
pharmaceutical industry and generic entrants battleground plays out uniquely for each drug in the
marketplace. Consequently, having an information advantage can benefit all the involved players. It
creates provisions for patent term extensions with exclusivity, expedited FDA approvals for
generic drugs, and a simplified patent litigation process tied to generic drug submissions to FDA.
Exclusivity can be granted in addition to USPTO patent terms following the approval of a drug
if the product has orphan drug designation, classification as a new chemical entity, done
additional clinical studies, or studies in paediatric populations.

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3.3 Global Impact and Implications of Impending Patent Cliff
Pharmaceutical companies with products going off patent closely monitor their patent
portfolios and release information about impending patent expirations as part of their financial
disclosures. Overall, the patent cliff from 2023 to 2030 is expected to be of tectonic magnitude
and represents a critical period in the pharmaceutical industry, where companies will face
challenges and opportunities as they navigate the expiration of patents for high-revenue drugs
and the ensuing competition from generic alternatives. The global impact of the patent cliff
from 2022 to 2030 is expected to be significant and will depend on various factors, including
the specific drugs facing patent expiration, regional market dynamics, healthcare policies, and
the ability of pharmaceutical companies to adapt to the changing landscape. The innovator
companies will be monitoring market trends and regulatory changes and will employ various
strategies to navigate the implications of the patent cliff during this period. However, some of
the potential implications of impending Patent cliff 2022-2030 are mentioned below:
● Steep Revenue Loss for Pharmaceutical Companies with small molecules:
Innovator Pharmaceutical companies that hold patents on drugs facing expiration will
experience a decline in sales as generic competition enters the market. This revenue
loss can have a considerable impact on these companies' financial performance,
potentially leading to decreased profits, restructuring, and strategic adjustments. For
example, during the last patent cliff, for the biggest selling statin Lipitor, the annual sales
fell from nearly $11 billion in 2010, the year before it faced generics in the U.S., to $4
billion in 2012. Pfizer’s overall revenue fell from $68 billion to $59 billion over the same
period. The impending cliff will affect most big biopharma companies, but some will feel
more pressure than others. Pfizer Inc., Novartis AG, Merck, Eli Lilly and Bristol Myers
Squibb are poised to face steep patent cliffs.
● Gradual Revenue Loss for Pharmaceutical Companies with Large molecules:
The companies with large molecules like Biosimilars and Mono Clonal Antibodies
(MABs) also going to face price erosion resulting in loss of revenues however this will
be gradual. This is because large molecules are more expensive to develop and
manufacture and their manufacturers won’t be able to afford cutting prices by nearly
as much as by manufacturers of generic small molecules. For example; The pattern of
sales decline for drugs like AbbVie’s blockbuster biosimilar Humira is expected to be
different as such drugs won’t be interchangeable, or directly substitutable, by
pharmacists. Physicians also may be reluctant to switch stable patients on the branded
drug to biosimilars. Therefore, it is expected that newly diagnosed patients are most
likely to receive biosimilars in the beginning after launch of biosimilars. With the
introduction of generic alternatives, patient and healthcare provider education
becomes crucial. Clear communication and education initiatives can help dispel
concerns about the efficacy and safety of generic medications. It is important to ensure
that patients and healthcare providers are informed about the availability of generic
options, their cost-saving potential, and the importance of therapeutic equivalence.

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 ● Savings for the Patients and Healthcare Systems:
The expiration of patents during this 2023-30 will pave the way for multiple generic drug
manufacturers to enter the market and produce lower-cost alternatives to brand-name
drugs. This increased availability of affordable medications can improve access to
essential treatments for patients worldwide, particularly in regions with limited
healthcare budgets. Generic medications are typically priced up to 90% lower than their
brand-name counterparts, allowing healthcare providers and insurers to achieve
substantial cost savings. This will reduce financial burdens on payers in the healthcare
systems and potentially lead to expanded coverage and access to more comprehensive
healthcare.

● Market Competition and Innovation:

The patent cliff fosters increased market competition, as generic manufacturers
compete with brand-name companies. This competition can drive innovation and
encourage the development of new drugs, as companies strive to differentiate
themselves in the market. Pharmaceutical companies may focus on research and
development efforts to introduce novel therapies, potentially leading to advancements
in treatment options for various diseases and conditions.

● Market Share Shifts:

The Patent cliff and resulting loss of exclusivity can reshape the competitive landscape
and influence market dynamics within the pharmaceutical industry. As per historical
data, the sales of a small molecule that goes generic, 50- 80% of the market can be lost
in 30 to 90 days and the price can go down by 90%. The expiration of patents can result
in major shifts in market shares between innovator and generic drug manufacturers.
Generic manufacturers may gain market share as they offer lower-priced alternatives,
while innovator companies may experience a decline in their market position unless
they come up adequate strategies.

● Regional and Global Market Variations:

It's important to note that the specific drugs and their patent expiration dates during
the 2022-2030 period will vary. Further, the impact of the patent cliff will also vary
across different regions and countries due to variations in healthcare systems, political,
economic, social, legal and regulatory frameworks. Some regions may experience a
more pronounced impact, depending on factors such as the prevalence of brand-name
drugs facing patent expirations and the availability of generic manufacturers in the
market.

3.4 Patent Expirations by numbers (Patent cliff 2020-2030)

As per the report by drug patent watch during the patent cliff period of 2022-2032 there
will more than 300 drug patents (Exhibit 2) in different categories and different
geographies expiring every year. A list of 300 plus US patents expiring between 2020-2030

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 is attached as Annexure A at the end of the report. This trend is going to continue till the
year 2036. However, the most important and high value patents for the blockbuster
(Annual sales more than USD 1 Bn) drugs are going to expire between the years
2022-2030.

Exhibit 2 : Patent Expirations by Year

Source: Drug Patentwatch.com

3.5 Major Blockbuster drug Patent Expirations during the Patent cliff 2020-2030
As per our analysis, 24 major blockbuster drug patents are going to expire during the period of
2022-2030. This will include the loss of exclusivity for the mega-seller like Humira (adalimumab)
in the US beginning in 2023. Biosimilars to Humira were already launched in Europe in 2019,
which has already frayed at the brand's sales, though Europe already was a substantially smaller
market for Humira revenues compared to the US. In India, multiple companies have been
permitted by the Indian government to manufacture Adalimumab under the provisions of
compulsory licensing since 2018. Biocon has become the first company from India to launch its
Biosimilar Hulio in US in July,2023. Johnson & Johnson will have to navigate a challenging period
around the same time, with the company's top-selling drug Stelara (Ustekinumab) expected to
lose patent protection in the US in 2023, followed by Simponi (golimumab) in 2024.

Similarly, Pfizer is headed over the cliff with the potential US loss of the rheumatoid arthritis
drug Xeljanz (tofacitinib) in 2025, the blood thinner Eliquis (Apixaban) in 2026, and the cancer
drugs Ibrance (Palbociclib) and Xtandi (enzalutamide) in 2027. BMS which markets Eliquis with
Pfizer but will experience other losses as well. This year, it is already under pressure, facing the
loss of Revlimid (lenalidomide) in Europe and Japan and on a volume-limited basis in the US.

Opdivo (Nivolumab) is going to be off-patent in 2028. At Merck, meanwhile, the entire plotline
is pivoting on its checkpoint inhibitor Keytruda (Pembrolizumab) and how the company will
reduce its dependence on the big anchor brand before it faces loss of exclusivity in 2028.

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Exhibit 3 and Exhibit 4 below mentions the top 24 blockbuster drugs going off-patent during
the patent cliff, their respective sales in year 2022, their annual CAGR and forecasted sales for
year 2026, 2028 and 2030.

Exhibit 3: Top 24 blockbuster drugs going off-patent during the patent cliff 2022-2030

Sales
in $ Forecasted Forecasted Forecasted
Name of the Drug/ Active Type pf Bn in CAGR Market in Market in Market in
S. No Ingredient molecule 2022 % 2026 $ Bn 2028 $ Bn 2030 $ Bn
1 Humira (Adalimumab) Large 21.20 5.11 25.87 28.58 36.72
Keytruda Large 21.00
2 (Pembrolizumab) 1.87 22.62 23.47 25.36
3 Revlimid (Lenalidomide) Small 10 6.5 12.86 14.59 16.55
4 Eliquis (Apixaban) Small 1.76 11 2.67 3.29 4.05
5 Eylea (Aflibercept) Large 7.42 5 9.01 9.94 10.96
6 Stelara (Ustekinumab) Large 9.72 8.1 13.27 15.51 18.12
7 Opdivo (Nivolumab) Large 9.50 33.3 29.99 53.29 94.7
8 Tivicay (Dolutegravir) Small 3.74 6.2 4.75 5.39 6.05
Ibrance (Palbociclib) Small 5.12
9 13.4 8.46 10.88 14
10 Januvia (Sitagliptin) Small 4.50 5.02 5.47 6.09 6.66
11 Trulicity (Dulaglutide) Large 7.40 6.48 9.51 10.78 12.23
Prolia/Xgeva Large 3.60
12 (Denosumab) 9 5.08 6.03 7.17
13 Cosentyx (Secukinumab) Large 4.78 5.8 5.98 6.7 7.5
14 Entyvio (Vedolizumab) Large 6.40 3.6 7.37 7.91 8.49
Victoza (Liraglutide) Large 1.81
15 5.8 2.26 2.53 2.69
Avastin (Bevacizumab) Large 2.30
16 9.2 3.27 3.9 4.65
17 Enbrel (Etanercept) Large 4.12 3.3 4.69 5 5.34
18 OxyContin (Oxycodone) Small 8.90 5.7 11.1 12.41 13.86
19 Lantus (Insulin Glargine) Large 2.30 18 4.46 6.2 8.64
20 Lucentis (Ranibizumab) Large 1.80 6.9 2.35 2.6 3.07
Symbicort (Budesonide) Small 2.54
21 18.01 4.92 6.86 9.55
Crestor (Rosuvastatin) Small 1.05
22 6 1.42 1.48 1.67
23 Lyrica (Pregabalin) Small 1.12 7.67 1.51 1.74 2.02
Xarelto (Rivaroxaban) Small 7.40
24 1.5 7.85 8.09 8.04

Source: Product Sales data and CAGR as per Global data/ Statista/Company’s Annual report

18 | Page IMPENDING PATENT CLIFF 2022-2030

Exhibit 4:

Source: Product Sales data and CAGR as per Global data/ Statista/Company’s Annual reports

3.6 Cost Savings from generic drug prescription: The estimated annual cost savings from the
prescription of generic drugs can vary significantly depending on the specific country,
healthcare system, and the volume of generic drug use. However, generic drugs are
generally known to be much more cost-effective than their brand-name counterparts,
leading to substantial savings for individuals, healthcare systems, and governments.
According to various studies and reports, the cost savings achieved by using generic drugs
can range from 20% to 90% compared to the price of brand-name medications. As per our
analysis, on average, generic chemical drugs after launch tend to cost around 51 % less than
brand-name drugs for a few years. In case of biosimilars, the cost can be around 60% less
than innovator products for a few years, It is to be noted that with passage of time and
entry of new players, the prices of both chemical generics and biosimilars reduce

19 | Page IMPENDING PATENT CLIFF 2022-2030

 substantially. The lower R&D and manufacturing costs, relatively easier and quick
regulatory approvals bring cost efficiencies, thereby promoting inter-generic competition
and offers the price benefits to patients and insurance providers especially for chronic
conditions or high-prevalence diseases.

3.7 Shift from Chemical generics to Biosimilars by 2030: As per the data analysis conducted for the
sales of 24 blockbuster drugs, biologics like biosimilars, immunomodulators and monoclonal antibodies
are going to further dominate the pharmaceutical industry between 2022-2030. The biosimilar revenues
which comprised 69 % of overall revenues of these 24 blockbuster drugs in 2022 is going to increase to
75% by 2030 (Exhibit:5) New pharmaceutical technological advancements like high-throughput
screening, molecular profiling, next-generation sequencing, bioinformatics analysis, proteomics, and
other molecular profiling techniques have paved the way for personalized medicine approaches in drug
development which has led to more biologics reaching the market.

Exhibit 5

Source: Market Forecast /Intelligence (BHPL)/ DrugPatentwatch.com

3.8 Classification of Blockbuster Drugs going off-patent between 2022-2030 (On the basis of Type of
molecule, Disease/ Indication, Pharmacological classification and Dosage form)

Drugs can be roughly split into two categories based on their technical characteristics, and into two
other categories based on their regulatory characteristics. The two technical categories are
pharmaceutical drugs, commonly referred to as small-molecule drugs, and biotech drugs, commonly
referred to as biologic drugs. The most popular, and oldest, technical category of drugs is small-molecule
drugs. These drugs, also commonly called pharmaceutical drugs, tend to be orally administered as
tablets, capsules, or liquids. Most small-molecule drugs are able to cross the stomach lining into the
bloodstream where they travel throughout the body until they arrive at their therapeutic target. The

20 | Page IMPENDING PATENT CLIFF 2022-2030

therapeutical target of the drug describes its pharmacological classification. Some of the analysed
blockbuster drugs have application in multiple therapeutic areas and disease indications providing a
much bigger market opportunity for such drugs. Exhibit 6 Table below for the classification of the
blockbuster drugs going off patent between 2022-2023 on the above-mentioned parameters.

Exhibit: 6 Classification of Blockbuster Drugs going off-patent between 2022-2030 (On the basis of
Type of molecule, Disease/ Indication, Pharmacological classification and Dosage form)
Drug/Active Parent Disease Type of Dosage Pharmacological
Ingredient Company Indication/s Molecule Form Classification
Humira AbbVie Arthritis, plaque Large Injection Tumor necrosis
(Adalimumab) Psoriasis, factor (TNF)
Hidradenitis Blockers
Suppurativa,
Crohn’s Disease,
Ankylosing
Spondylitis,
Ulcerative Colitis,
Non-Infectious
Uveitis
Keytruda Merck & Co Melanoma, lung Large Injection Monoclonal
(Pembrolizumab) cancer, head and Antibody
neck cancer,
Hodgkin
lymphoma,
stomach cancer,
cervical cancer,
breast cancer
Revlimid Celgene Myeloma, Small Capsules Immunomodulat
(Lenalidomide) Corporation, smoldering ory Drugs
a Bristol- myeloma, and (ImiDs)
Myers myelodysplastic
Squibb syndromes
Company
Eliquis (Apixaban) Bristol- Treats and Small Tablet Factor Xa
Myers prevents blood inhibitors
Squibb clots and to
Company prevent stroke

Eylea Regeneron Wet macular Large Injection Vascular

(Aflibercept) and Bayer degeneration and endothelial
metastatic growth factor A
colorectal cancer (VEGF-A)
antagonists

21 | Page IMPENDING PATENT CLIFF 2022-2030

 Stelara Jansssen Crohn's disease, Large Injection Human IgG1
(Ustekinumab) Biotech ulcerative colitis, Monoclonal
plaque psoriasis Antibody
and psoriatic
arthritis

Opdivo Bristol Cancer Large Injection Human

(Nivolumab) Myers Monoclonal
Squibb Antibody

Tivicay ViiV HIV/AIDS Small Tablet HIV integrase

(Dolutegravir) Healthcare inhibitors

Ibrance Pfizer Breast Cancer Small Capsule CDK 4/6

(Palbociclib) Oncology inhibitors

Januvia Merch & Type 2 Diabetes Small Tablet Dipeptidyl

(Sitagliptin) Co. peptidase-4
(DPP-4) inhibitor
Trulicity Eli-Lilly Type 2 diabetes to Large Injection Glucagon-like
(Dulaglutide) prevent peptide-1 (GLP-
cardiovascular 1) agonists
diseases
Prolia/Xgeva Amgen Osteoporosis, Large Injection Monoclonal
(Denosumab) treatment-induced Antibodies
bone loss,
metastases to
bone, and giant cell
tumor of bone

Cosentyx Novartis Psoriasis, Large Injection Monoclonal

(Secukinumab) Ankylosing Antibodies
spondylitis,
Psoriatic arthritis

Entyvio Millenium Ulcerative colitis Large Injection integrin receptor

(Vedolizumab) Pharmaceut and Crohn's antagonists
icals disease

22 | Page IMPENDING PATENT CLIFF 2022-2030

 Victoza Novo Type 2 diabetes, Large Injection GLP-1 Analog
(Liraglutide) Nordisk obesity, and
chronic weight
management

Avastin Genentech First-line treatment Large injection Monoclonal

(Bevacizumab) of unresectable, Antibody and
locally advanced, anti-
recurrent or angiogenesis
metastatic non– drug
squamous non–
small cell lung
cancer in
combination with
carboplatin and
paclitaxel

Enbrel Immunex Active ankylosing Large Injection anti-TNFs or TNF

(Etanercept) Corporation spondylitis (AS), blockers
plaque psoriasis

OxyContin Purdue Moderate to Small Tablet opiate (narcotic)

(Oxycodone) Pharma LLP severe pain analgesics.

Lantus Sanofi Pediatric patients Large Injection long-acting

(Insulin Glargine) with type 1 insulin
diabetes mellitus
or adult patients
with type 2
diabetes mellitus
who require basal
(long-acting) insulin
for the control of
hyperglycemia

Lucentis Genentech macular edema Large Injection vascular

(Ranibizumab) following retinal endothelial
vein occlusion growth factor A
(RVO) (VEGF-A)
antagonists

23 | Page IMPENDING PATENT CLIFF 2022-2030

 Symbicort Astrazeneca Asthma in patients Small Respules Long-acting beta
(Budesonide/for 12 years of age and agonists
moterol) older and COPD

Crestor AstraZeneca Homozygous Small Tablet HMG-CoA

(Rosuvastatin) familial reductase
hypercholesterole inhibitors
mia, (statins)
Hyperlipidemia,
Mixed
dyslipidemia,
primary
dysbetalipoprotein
emia,
hypertriglyceridemi
a, and prevention
of cardiovascular
disease
Lyrica Pfizer Fibromyalgia, Small Tablet/ Alpha-2 delta
(Pregabalin) diabetic nerve pain, Syrup ligand.
spinal cord injury
nerve pain, and
pain after shingles
in adult patients.
LYRICA is also
indicated to treat
partial-onset
seizures

Xarelto Janssen To reduce the risk Small Tablets Factor Xa

(Rivaroxaban) Pharmaceut of stroke and inhibitors
icals/Bayer systemic embolism
in adult patients
with nonvalvular
atrial fibrillation
(AF).

Source: Company’s Websites/ Annual Reports/ CTRI/ Product Brochures/Leaflets

24 | Page IMPENDING PATENT CLIFF 2022-2030

3.9 US Patent Number and Patent Expiry Date of Blockbuster Drugs going off-patent between
2022-30
Exhibit 7 below details the US Patent Number/s and Patent Expiry Date of Blockbuster Drugs going off-
patent between 2022-30

Exhibit 7

Drug/Active Ingredient Parent Company US Patent Year of Patent Expiry

Number/s

Humira (Adalimumab) AbbVie US6090382A December 31, 2016

US9187559B2 April 11, 2025
US8969024B2 May 10, 2032
US9315574B2 November 12, 2033
US9273132B2 April 04, 2027
US9085618B2 March 14, 2033
US9284371B2 September 13,
US8663945B2 2027

Keytruda Merck & Co US94458307P June 13, 2028

(Pembrolizumab) US8551967B2 September 5, 2031

Revlimid (Lenalidomide) Celgene Corporation, a US7855217 November 24, 2024

Bristol-Myers Squibb US7465800 April 27, 2027
Company

Eliquis (Apixaban) Bristol-Myers Squibb US6967208 November 21, 2026

Company

Eylea (Aflibercept) Regeneron and Bayer US7070959B2 November 11, 2024

25 | Page IMPENDING PATENT CLIFF 2022-2030

 Stelara (Ustekinumab) Jansssen Biotech US7279157B2 January 13, 2022
US9409984B2 February 27, 2022
US7166285B2 May 3, 2022
US8080247B2 August 2, 2022
US6902734B2 September 25, 2023
Opdivo (Nivolumab) Bristol Myers Squibb US9393301B2 July 2, 2023
US8168179B2 July 2, 2023
US9067999B1 July 2, 2023
US9073994B2 July 2, 2023
US9439962B2 July 2, 2023
US9402899B2 February 5, 2024
U57595048B2 August 8, 2024
US8728474B2 August 8, 2024
Tivicay (Dolutegravir) ViiV Healthcare US8129385 October 5, 2027
US9242986 December 8, 2029
US10426780 January 24, 2031

Ibrance (Palbociclib) Pfizer Oncology US6936612 January 16, 2023

US7208489 January 16, 2023
USRE47739 March 5, 2027
US10723730 February 8, 2034

Januvia (Sitagliptin) Merch & Co. US7326708 May 24, 2027

Trulicity (Dulaglutide) Eli-Lilly US10369003132 October 15, 2024

US10376376B2 October 15, 2024
US10610371B2 October 15, 2024
US11083591B2 October 15, 2024
US905601892 October 15, 2024
US986771292 October 15, 2024
US10695187B2 June 28, 2025
US8273854B2 May 15, 2026
US10130493B2 July 17, 2026
US8535379B2 December 13, 2026
US11135072B2 April 11, 2027

Prolia/Xgeva Amgen US8409578B2 June 25, 2022

(Denosumab) US8058418B2 November 30, 2023
US7364736B2 February 19, 2025
Cosentyx (Secukinumab) Novartis US7807155 Feb 09. 2030

26 | Page IMPENDING PATENT CLIFF 2022-2030

 Entyvio (Vedolizumab) Millenium WO2016086147A June 2023
Pharmaceuticals 1

Victoza (Liraglutide) Novo Nordisk US6268343 February 22, 2023

US8114833 February 13, 2026

Avastin (Bevacizumab) Genentech US20150147317A January 2022

1
Enbrel (Etanercept) Immunex Corporation US8163522B1 April 24, 2029
US8063182B1 November 22, 2028
NL300129I2 July 02, 2023

OxyContin (Oxycodone) Purdue Pharma LLP US10696684 March 30, 2025

US10407434 March 30, 2025
US9522919 March 30, 2025
US9073933 March 30, 2025
Lantus (Insulin Glargine) Sanofi US8048854B2 July 05, 2027
EP2575865B1 May 27, 2031

Lucentis (Ranibizumab) Genentech DE202012011260 November 24, 2022

U1

Symbicort AstraZeneca US20210069215A January 29, 2023

(Budesonide/formoterol) 1

Crestor (Rosuvastatin) AstraZeneca US6316460B1 August 04, 2020

US6858618 June 17, 2022

Lyrica (Pregabalin) Pfizer US8044227B2 October 10, 2028

Xarelto (Rivaroxaban) Janssen US7157456 August 28, 2024

Pharmaceuticals/Bayer

Source: Drugpatentwatch.com

27 | Page IMPENDING PATENT CLIFF 2022-2030

3.10 Ease of Technology Transfer & Potential Indian Generic companies that can benefit from the
Patent Cliff:
Biologic drugs are much larger than small-molecule drugs and are generally injectables. Unlike small-
molecule drugs, which are often synthetic chemicals which never occur naturally, many biologic drugs
are synthetic versions of naturally-occurring proteins, such as growth factors, monoclonal antibodies,
hormones, and immune-system signalling molecules. These differences also have product development
technology transfer, legal and regulatory consequences. Indian generic companies have wide
experience of reverse engineering the chemical drugs to develop generic versions and transfer the
technology for the mass production. However, for the Biosimilar, the development and technology
transfer are challenges. Further, the types of patents used for small-molecule and biologic drugs, and
the strategies for using (or attacking) these patents are also very different from Biosimilars. Likewise,
the regulatory and commercial consideration in gaining approval for new or follower small-molecule
and biologic drugs are very different making the Biosimilars a riskier and complex proposition for Indian
generic companies. However, a few Indian companies have explored this foray and developed the initial
capabilities. The table mentioned below (Exhibit 8) captures the potential Indian generic companies
which have a opportunity to grab the market share which is going to be created in between 2022-2030.

Exhibit 8

Drug/Active Ingredient Parent Company Ease of Generic

Technology companies with
Transfer capability to tap
the Opportunity
Humira (Adalimumab) AbbVie Low Biocon, Hetero
Healthcare, Zydus,
Cipla, Reliance Life
sciences, Cadila,
RGP life sciences,
Glenmark, Alkem,
IPCA, Torrent
Keytruda Merck & Co Low Zuvius Lifesciences,
(Pembrolizumab) Beta drugs Ltd., Taj
Oncology, Getwell
oncology

Revlimid (Lenalidomide) Celgene Corporation, Moderate Intas, Fierrece,

a Bristol-Myers Squibb Natco, Dr Reddy's,
Company Hetero, Cipla,
Zydus
Eliquis (Apixaban) Bristol-Myers Squibb Moderate Gland, Shinepro,
Company MITS, Bharat
Serums & Vaccines
Ltd,

28 | Page IMPENDING PATENT CLIFF 2022-2030

 Eylea (Aflibercept) Regeneron and Bayer Low Hetero Healthcare,
Macleods, Aculife,
Natco, Biocon

Stelara (Ustekinumab) Jansssen Biotech Low Orion, Biocon,

Hetero Healthcare,
Zydus, Cipla,
Reliance Life
sciences, Cadila,
RGP life sciences,
Glenmark, Alkem,
IPCA, Torrent
Opdivo (Nivolumab) Bristol Myers Squibb Low Alembic Pharma,
Dr. Reddy, SG
BioPharma, Intas,
Emcure
Tivicay (Dolutegravir) ViiV Healthcare Moderate Cipla, Natco,
Mylan, Hetero,
Emcure,
Aurobindo, Laurus,
Adcock, SUN
Pharma
Ibrance (Palbociclib) Pfizer Oncology Moderate Alembic Pharma,
Dr. Reddy, SG
BioPharma,
Biozenta,
Healthkind, Intas,
Emcure

Januvia (Sitagliptin) Merch & Co. Moderate Menarni, Dr

Reddy's, Actis
generics, Akum's
Lifesciences, Teva
pharmaceuticals

Trulicity (Dulaglutide) Eli-Lilly Low Lupin

Prolia/Xgeva Amgen Low Cadila, Intas, Dr

(Denosumab) Reddy’s, Zydus,
Alkem

29 | Page IMPENDING PATENT CLIFF 2022-2030

 Cosentyx (Secukinumab) Novartis Low Hetero Healthcare,
Zydus, Cipla,
Reliance Life
sciences, Cadila,
RGP life sciences,
Glenmark, Alkem,
IPCA, Torrent
Entyvio (Vedolizumab) Millenium Low Biocon, Hetero
Pharmaceuticals Healthcare, Zydus,
Cipla, Reliance Life
sciences, Cadila,
RGP life sciences,
Glenmark, Alkem,
IPCA, Torrent
Victoza (Liraglutide) Novo Nordisk Low Cipla, Lifesciences,
Glenmark, Zydus

Avastin (Bevacizumab) Genentech Low Reliance Life

sciences, Hetero,
Intas, Dr Reddys,
Zydus, Lupin

Enbrel (Etanercept) Immunex Corporation Low Cipla, Intas

OxyContin (Oxycodone) Purdue Pharma LLP Moderate Lupin, Sun

Pharmaceuticals,

Lantus (Insulin Glargine) Sanofi Low Biocon Biologics

Lucentis (Ranibizumab) Genentech Low Intas

30 | Page IMPENDING PATENT CLIFF 2022-2030

 Symbicort AstraZeneca Moderate Glenmark, Intra
(Budesonide/formoterol) Labs, Lupin,
Macleods, Dr
Reddy’s, Cipla,
Intas.
Crestor (Rosuvastatin) AstraZeneca Moderate Sun Pharma,
Aurobindo Pharma
and Glenmark
Pharma, Biocon,
MSN Laboratories,
Lupin, Glenmark,
Unichem, Torrent,

Lyrica (Pregabalin) Pfizer Moderate Intas, Glenmark,

Aristo, Abbott, Sun
pharma, , Cipla,
Zydus Cadila,
Unichem, Torrent,
Lupin

Xarelto (Rivaroxaban) Janssen Moderate Dr Reddy's, Taj

Pharmaceuticals/Baye Generics, Natco,
r

Source: Company’s Websites/ Annual Reports/ CTRI/ Product Brochures/Leaflets

31 | Page IMPENDING PATENT CLIFF 2022-2030

4. ASSESSMENT OF BLOCKBUSTER DRUGS GOING OFF-PATENT BETWEEN 2022-2030

32 | Page IMPENDING PATENT CLIFF 2022-2030

Humira
Innovator Company: Abbvie Inc.

API/Salt/Composition: Adalimumab

Pharmacological Classification:

Tumor Necrosis Factor (TNF) Blockers

Dosage Form: Subcutaneous Injection

Dosage Strength:

● Single-dose prefilled pen (HUMIRA Pen): 80 mg/0.8 mL, 40 mg/0.8 mL, and 40 mg/0.4 mL
● Single-dose prefilled glass syringe: 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20
mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL, 10 mg/0.1 mL

Patent Number and Expiration Date:

● US6090382A December 31, 2016 (Expired)

● US9187559B2 April 11, 2025
● US8969024B2 May 10, 2032
● US9315574B2 November 12, 2033
● US9273132B2 April 04, 2027
● US9085618B2 March 14, 2033
● US9284371B2/ US8663945B2, September 13, 2027
The company owns 257 Humira-related patents including ancillary Uses, such as manufacturing
methods and administering Humira.

Indications: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing

Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa and Uveitis

Global Market:

The revenue of the pharmaceutical product Humira has increased from 2011 to 2022, generating 7.9
billion U.S. dollars in 2011 and a record high of 21.2 billion U.S. dollars in 2022. Humira is expected to
continue its success soon. The global market is expected to grow at a CAGR of 5.11% between 2023 to
2028. As a result, the market size is anticipated to grow by USD 11.6 billion in 2028. 1,2

Potential Generic Manufacturers in INDIA:

The Indian market for Adalimumab was estimated to be USD 16.16 Million in the year 2014. It has been
steadily growing @annual CAGR of around 5% since then. Many companies in India have announced the
biosimilar launch of Adalimumab. Biocon Biologics, a subsidiary of Biocon launched a biosimilar version
of Humira in the US market under brand name HULIO in July,2023. Hetero Drugs had launched its
biosimilar Mabura in 2018 in Indian market, while Glenmark Pharmaceuticals Ltd signed a licencing
agreement with Zydus Cadila to create another adalimumab brand, Adaly. Cadila had already launched
their generic version Cadalimab in 2020 in Indian market.
1.https://www.statista.com/statistics/318206/revenue-of-humira

2. https://marketdataforecast.com/market-reports/global-humira-market

33 | Page IMPENDING PATENT CLIFF 2022-2030

Keytruda

Innovator Company:

Merck & Co.

API/Salt/Composition:

Pembrolizumab

Pharmacological Classification:

Monoclonal Antibody

Dosage Form:

Intravenous Injection

Dosage Strength:

● For injection: 50 mg lyophilized powder in a single-use vial for reconstitution

● Injection: 100 mg/4 mL (25 mg/mL) solution in a single-use vial

Patent Number and Expiration Date:

● US94458307P June 13, 2028

● US8551967B2 September 5, 2031
Merck has filled 129 patents linked to Keytruda which could extend its exclusivity to 2036. 74% cover
different indications and formulations of the drug, not the key antibody

Indications:

Melanoma, Non-small Cell Lung Cancer, Head and Neck Cancer

Global Market:

Keytruda is one of the best-selling drugs worldwide, generating nearly 21 billion U.S. dollars in revenue
during 2022 & forecast to bring annual revenue of 22.2 billion U.S. dollars by 2025. 1,2

Potential Generic Manufacturers in INDIA:

NeuClone and Serum Institute of India has agreed to co-develop biosimilar monoclonal antibodies and
has reached the Preclinical Phase.

1. https://www.statista.com/statistics/1269401/revenues-of-keytruda/
2. https://www.pharmaceutical-technology.com/comment/keytruda-projections/

34 | Page IMPENDING PATENT CLIFF 2022-2030

Revlimid

Innovator Company:

Celgene (Bristol Myers Squibb)

API/Salt/Composition: Lenalidomide

Pharmacological Classification:

Immunomodulatory Drugs (ImiDs)

Dosage Form: Capsules

Dosage Strength:

● 2.5mg, 5mg, 10mg, 15mg, 20mg, 25mg

Patent Number and Expiration Date:

● US7855217 November 24, 2024

● US7465800 April 27, 2027

As per FDA’s orange book, Celgene has 27 patents for Revlimid listed. Four are listed as patents for active
ingredient & five are "drug product" patents.

Indications:

Multiple Myeloma, maintenance therapy following autologous hematopoietic stem cell transplantation,
Transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS),
Mantle cell lymphoma (MCL), follicular lymphoma, Marginal zone lymphoma (MZL)

Global Market:

Top product Revlimid between 2008 to 2022 became the leading cancer drug, generating 10 billion US
dollars. The Global Lenalidomide market is growing at a CAGR of 6.5% in the forecast period (2023-
2030).1,2

Potential Generic Manufacturers in INDIA:

The Indian market for Revlimid was estimated to be around USD 2.3 Billion in the year 2021. Many
generic lenalidomide variants are present in the Indian market. Natco Pharma Ltd, Dr Reddy’s
Laboratories Ltd, Sun Pharmaceuticals Ltd, Cipla Ltd, Panacea Biotec Ltd, United Biotech Pvt Ltd, Intas
Pharmaceuticals Ltd, SR Pharmaceuticals, Zydus Cadila are the companies that have launched their
generics in the Indian market.

1. https://www.statista.com/statistics/1269411/revenues-of-revlimid/

2. https://dataintelo.com/report/lenalidomide-drug-market

35 | Page IMPENDING PATENT CLIFF 2022-2030

Eliquis
Innovator Company:

Bristol Myers Squibb / Pfizer

API/Salt/Composition: Apixaban

Pharmacological Classification: Factor Xa Inhibitors

Dosage Form: Tablets

Dosage Strength:

● 2.5mg, 5mg

Patent Number and Expiration Date:

● US6967208 November 21, 2026

There are 169 international patents filed for Apixaban by Bristol
Myers Squibb.

Indications:

● Stroke risk reduction in nonvalvular AF

● DVT/PE treatment & reduction in risk of recurrence following initial therapy
● Prophylaxis of DVT after hip or knee replacement surgery

Global Market:

Eliquis has added over $1 billion in sales each year since 2014. While the strong growth could continue
for Eliquis in the coming years. It is estimated that the drug’s revenues could grow at a CAGR of 11%. In
2022, the market was valued at USD 1.76 billion and would grow to USD 2.90 Billion by 2030.1,2

Potential Generic Manufacturers in INDIA:

Cipla planned to launch the generic version of Apixaban under the probable brand name Apigy.
Emcure, Natco, Pulse, Intas, La Renon Healthcare, Cadila, Torrent, Sun, and Micro Labs had already
launched their apixaban generics in India.

1. https://www.forbes.com/sites/greatspeculations/2019/08/23/can-eliquis-continue-to-add-1-billion-in-annual-sales-for-bristol-myers-squibb/?sh=2ee2b3712267

2. https://www.databridgemarketresearch.com/reports/global-apixaban-market#:~:text=The%20market%20was%20valued%20at,USD%202%2C908.17%20million%20by%202030.

36 | Page IMPENDING PATENT CLIFF 2022-2030

Eylea
Innovator Company:

Regeneron and Bayer

API/Salt/Composition:

Aflibercept

Pharmacological Classification:

Vascular Endothelial Growth Factor A (VEGF-A)

antagonists

Dosage Form: Intravitreal Injection

Dosage Strength:

● 2 mg/0.05 mL

Patent Number and Expiration Date:

● US7070959B2 November 11, 2024

Regeneron listed 29 patents in connection with EYLEA, four of which do not expire until 18 August 2040

Indications:

● Neovascular (Wet) Age-Related Macular Degeneration (AMD)

Global Market:

Eylea's Market size was valued at USD 7.2 Billion in 2021, USD 7.42 billion in 2022 to USD 7.79 billion in
2023 with a compound annual growth rate (CAGR) of 5.0% and is projected to reach USD 10 Billion by
2030, growing at a CAGR of 3.72% from 2023 to 2030.1,2

Potential Generic Manufacturers in India:

Joint venture Bayer Zydus Pharma of Bayer Healthcare and Zydus Cadila has been operating in the Indian
Market, focusing on women's healthcare, metabolic disorders, diagnostic imaging, cardiovascular
diseases, anti-diabetic treatments and oncology. This joint venture has launched Eylea in the Indian
Market.

1. https://www.verifiedmarketresearch.com/product/eylea-market/

2. https://www.researchandmarkets.com/report/eylea

37 | Page IMPENDING PATENT CLIFF 2022-2030

Stelara

Innovator Company:

Janssen Biotech

API/Salt/Composition:

Ustekinumab

Pharmacological Classification:

Human IgG1 Monoclonal Antibody

Dosage Form:

Subcutaneous Injection, IV Infusion

Dosage Strength:

● 130 mg/26 mL

Patent Number and Expiration Date:

● US7279157B2 January 13, 2022

● US9409984B2 February 27, 2022
● US7166285B2 May 3, 2022
● US8080247B2 August 2, 2022
● US6902734B2 September 25, 2023
Still, there are 23 Patents protecting Stelera.

Indications:

● Moderate to Severe Active Crohn’s Disease

● Moderate to Severe Active Ulcerative Colitis

Global Market: Stelara was introduced in 2009 and has been J&J’s top-selling drug since 2019, with sales
reaching USD 9.7 billion in 2022. Currently, it is expected J&J to bring in USD 54.5 billion in 2025.
According to Market Statsville Group, the global ustekinumab market size is expected to grow at a CAGR
of 8.1% from 2023 to 2033. 1,2,3

Potential Generic Manufacturers in INDIA: Indian drugmaker Intas Pharmaceuticals received a grant
for rights to commercialise DMB-3115, a proposed biosimilar to Janssen’s Stelara (ustekinumab), in all
global markets excluding Japan, South Korea and other Asian countries.

1. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-stelara-1127413/

2. https://www.reuters.com/business/healthcare-pharmaceuticals/stelara-patent-deal-puts-jj-back-path-57-bln-2025-revenue-forecast-2023-06-05/

3. https://www.linkedin.com/pulse/ustekinumab-market-size-expected-grow-cagr-81-2033-manjeet-ahirwar/

38 | Page IMPENDING PATENT CLIFF 2022-2030

Opdivo
Innovator Company: Bristol Myers Squibb

API/Salt/Composition: Nivolumab

Pharmacological Classification:

Vascular Endothelial Growth Factor A

(VEGF-A) antagonists

Dosage Form: Intravitreal Injection

Dosage Strength:

● 2 mg/0.05 mL

Patent Number and Expiration Date:

● US9393301B2 July 2, 2023

● US8168179B2 July 2, 2023
● US9067999B1 July 2, 2023
● US9073994B2 July 2, 2023
● US9439962B2 July 2, 2023
● US9402899B2 February 5, 2024
● U57595048B2 August 8, 2024
● US8728474B2 August 8, 2024

There are still One hundred and 92 patents active for Opdivo.

Indications:

Non-Small Cell Lung Cancer (NSCLC), Melanoma, Advanced Kidney Cancer, Bladder or Urinary Tract
Cancer (Urothelial), Colorectal Cancer (MSI-H/dMMR), Classical Hodgkin Lymphoma, Gastric or
Gastroesophageal Junction or Esophageal Cancers, Malignant Pleural Mesothelioma

Global Market:

The Global Drug size of Opdivo was USD 1.78 billion in 2020 and sales stood at USD 9.5 Billion in 2022
and are expected to reach USD 25.68 billion by 2028, at a CAGR of 33.3% during the forecast period. 1,2

Potential Generic Manufacturers in INDIA:

There is no generic/biosimilar for Nivolumab in India to date. But many potential Anticancerous drug
manufacturers that can launch their biosimilars are Sun Pharma, Cadila, Dr Reddy’s, Natco, Hetero,
Glenmark etc.

1. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-opdivo-1127420/

2. https://dataintelo.com/report/global-nivolumab-drugs-sales-market/

39 | Page IMPENDING PATENT CLIFF 2022-2030

Tivicay

Innovator Company:

Viiv Healthcare

API/Salt/Composition:

Dolutegravir

Pharmacological Classification:

HIV integrase Inhibitors

Dosage Form:

Intravitreal Injection

Dosage Strength:

● Tablets: 10mg, 25mg, 50mg

● Paediatric Oral Suspension: 5mg

Patent Number and Expiration Date:

● US8129385 October 5, 2027

● US9242986 December 8, 2029
● US10426780 January 24, 2031
This drug has patent family members in 33 countries,

Indications:

● HIV/AIDS

Global Market:

Dolutegravir and Its Combination Drug market are expected to grow annually by 6.2% (CAGR 2023 -
2030), and the global revenue of Tivicay was USD 3.74 Billion in 2022(£ 285 million). 1,2

Potential Generic Manufacturers in INDIA:

Aurobindo Pharma, Cipla and Emcure Pharmaceuticals have launched their generic Dolutegravir for
HIV treatment in India.

1.https://www.marketwatch.com/press-release/dolutegravir-and-its-combination-drug-market-size-global-revenue-volume-market-share-production-cost-and-forecast-at-a-forecasted-62-
cagr-forecasted-from-2023-to-2030-2023-05-04

2.https://www.gsk.com/media/9847/fy-2022-results-announcement.pdf

40 | Page IMPENDING PATENT CLIFF 2022-2030

Ibrance
Innovator Company: Pfizer

API/Salt/Composition: Palbociclib

Pharmacological Classification:

CDK 4/6 inhibitors

Dosage Form: Capsules, Tablets

Dosage Strength:

● Capsule/Tablet: 125mg

Patent Number and Expiration Date:

● US6936612 January 16, 2023

● US7208489 January 16, 2023
● USRE47739 March 5, 2027
● US10723730 February 8, 2034

There are 6 patents protecting Ibrance and two Paragraph IV challenges.

Indications:

Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-)
Breast Cancer

Global Market:

Palbociclib (Ibrance) is expected to generate the largest revenue of USD 37.6 Billion by the end of 2030,
up from a revenue of USD 5.3 Billion in 2020 & USD 5.12 Billion in 2022 at the expected highest CAGR
of 13.4% during the forecast period. The market is segmented into pre-menopausal, post-menopausal,
and others. Out of these, the post-menopausal segment is expected to generate the largest revenue of
USD 35.7 Billion in 2030. 1,2

Potential Generic Manufacturers in INDIA:

BDR Pharmaceuticals recently launched a new generic drug Palbociclib with the brand name Bdpalbo
for the advanced treatment of metastatic breast cancer in India. Other than this Alkem, Sun Pharma,
Hetero, Zydus, Glenmark, MSN, Dr Reddy’s, Natco and Wembrace Biopharma has their biosimilar in
the Indian Market.

1. https://www.researchnester.com/reports/cdk-46-inhibitor-drugs-market/2533

2. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-ibrance-1127394/

41 | Page IMPENDING PATENT CLIFF 2022-2030

Januvia

Innovator Company: Merck & Co.

API/Salt/Composition: Sitagliptin

Pharmacological Classification:

Dipeptidyl Peptidase-4 (DDP-4) inhibitor

Dosage Form: Tablet

Dosage Strength:

● Tablet: 25mg, 50mg, 100mg

Patent Number and Expiration Date:

● US7326708 May 24, 2027

This drug has one hundred and twenty-seven patent family
members in forty-six countries. There has been litigation on patents covering JANUVIA.

Indications:

● Type-2 Diabetes

Global Market:

Januvia comprises the molecule Sitagliptin and Janumet contains Sitagliptin with metformin. Both drugs
treat type-2 diabetes and have a market size of USD 5.2 Billion & USD 4.5 Billion for the full year globally
in 2021 & 2022 respectively. The global diabetes treatment market is forecasted to grow at a CAGR of
5.02% from 2023 to 2028 and will be worth USD 118.77 billion by 2028 from USD 92.97 Billion.1,2,3

Potential Generic Manufacturers in INDIA:

Indian market for Sitagliptin was estimated to be around INR 3600 Crores in year 2022. Sun Pharma,
Torrent, Lupin, Glenmark, Dr Reddy’s, Medipol, Zydus, Aristo and Quest Pharma have launched their
Generics of Sitagliptin in the Indian Market.

1.https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2022-financial-results/

2. https://www.marketdataforecast.com/market-reports/global-diabetes-treatment-market

3. https://www.drugdiscoverytrends.com/50-of-2022s-best-selling-pharmaceuticals/

42 | Page IMPENDING PATENT CLIFF 2022-2030

Trulicity
Innovator Company: Eli Lilly

API/Salt/Composition: Dulaglutide

Pharmacological Classification: Glucagon-like peptide-4

(DPP-4) Inhibitor

Dosage Form: Injection

Dosage Strength: Injection: 0.75mg, 1.5mg, 3.0mg, 4.5mg

(0.5ml)

Patent Number and Expiration Date:

● US10369003132 October 15, 2024

● US10376376B2 October 15, 2024
● US10610371B2 October 15, 2024
● US11083591B2 October 15, 2024
● US905601892 October 15, 2024
● US986771292 October 15, 2024
● US10695187B2 June 28, 2025
● US8273854B2 May 15, 2026
● US10130493B2 July 17, 2026
● US8535379B2 December 13, 2026
● US11135072B2 April 11, 2027
Trulicity is covered with 31 low-certainty patents filed by Eli Lily with an estimated patent expiry year
up to 2040.

Indications: Type-2 Diabetes and Cardiovascular Diseases,

Global Market:

In 2022, Trulicity was Eli Lilly's biggest revenue generator with about 7.4 billion U.S. dollars. The global
glucagon-like peptide 1 (GLP-1) market was valued at USD 16.53 billion in 2021 and is probable to reach
USD 24.10 billion by 2027. 1,2

Potential Generic Manufacturers in INDIA:

There are currently no biosimilar alternatives to Trulicity only Lupin has launched its biosimilar as
Aplevant in the Indian Market.
1. https://www.statista.com/statistics/278214/eli-lilly-and-companys-top-products-based-on-revenue

2. https://www.prnewswire.com/news-releases/global-glucagon-like-peptide-1-glp-1-market-report-2023-a-24-1-billion-market-by-2027-from-16-53-billion-in-2021-w

43 | Page IMPENDING PATENT CLIFF 2022-2030

Prolia/Xgeva

Innovator Company: Amgen

API/Salt/Composition: Denosumab

Pharmacological Classification:

Monoclonal Antibodies

Dosage Form: Injection

Dosage Strength:

● Prolia 60 mg/1 mL single-use

prefilled syringe: 1 syringe every
6 months
● Xgeva 120 mg/1.7 mL single-use vial

Patent Number and Expiration Date:

● US8409578B2 June 25, 2022

● US8058418B2 November 30, 2023
● US7364736B2 February 19, 2025
Amgen seeks a declaratory judgement of infringement of 21 patents that cover denosumab (the active
ingredient in Prolia and XGEVA)

Indications:

Giant Cell Tumor of Bone, Hyperglycaemia of Malignancy, Bone Metastases from solid tumour and
Multiple Myeloma

Global Market:

Prolia/Xgeva had combined worldwide net sales of USD 3.6 billion in 2022 and sales of Prolia and Xgeva
has been growing @approximate CAGR 9% per year.1,2,3,4

Potential Generic Manufacturers in INDIA:

Dr Reddy’s, Intas, Cipla, Alkem, Zydus, Bioelite Lifesciences, RPG Lifesciences, and Biorange Biologicals
have launched their Biosimilars in the Indian Market of Prolia/Xgeva.

1. https://www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab

2.https://www.amgen.com/newsroom/press-releases/2023/01/amgen-reports-fourth-quarter-and-full-year-2022-financial-results

3. https://www.amgen.com/newsroom/press-releases/2022/02/amgen-reports-fourth-quarter-and-full-year-2021-financial-results

4. https://www.drugdiscoverytrends.com/50-of-2022s-best-selling-pharmaceuticals/

44 | Page IMPENDING PATENT CLIFF 2022-2030

Entyvio

Innovator Company:

Millennium Pharmaceuticals

API/Salt/Composition: Vedolizumab

Pharmacological Classification:

Integrin Receptor Antagonist

Dosage Form: Injection

Dosage Strength:

● Injection: 300mg in a single dose

Patent Number and Expiration Date:

● WO2016086147A1 June 2023

Entyvio is covered with 23 Low Certainty patents.

Indications:

● Moderately to severely active Ulcerative Colitis

● Moderately to severely active Crohn’s Disease

Global Market:

According to Global Data, the Entyvio global market size was USD 6.4 Billion in 2022, it is estimated that
the market growth for ulcerative colitis and Inflammatory Bowel disease is expected to grow at a
compound annual growth rate (CAGR) of 3.6% and 5.7% from 2023 to 2030 respectively.1,2,3

Potential Generic Manufacturers in INDIA:

There are no other Biosimilar of Vedolizumab in the market only Baxter India Pvt Ltd and Takeda have
launched it as Kynteles in Indian market.

1. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-entivio-1127430/

2. https://www.researchandmarkets.com/reports/5457623/inflammatory-bowel-disease-treatment-market

3. https://www.alliedmarketresearch.com/ulcerative-colitis-market

45 | Page IMPENDING PATENT CLIFF 2022-2030

Victoza

Innovator Company: Novo Nordisk

API/Salt/Composition: Liraglutide
Pharmacological Classification: GLP-1 Analog
Dosage Form: Injection
Dosage Strength: 1.2mg/1.8mg
Patent Number and Expiration Date:
● US6268343 February 22, 2023
● US8114833 February 13, 2026

This drug has one hundred and 97 patent family

members in 32 countries. There has been litigation on patents covering VICTOZA.

Indications:
● Along with diet and exercise to lower blood sugar (glucose) in adults and children 10
years of age and older with type 2 diabetes mellitus.
● To reduce the risk of major cardiovascular events such as heart attack, stroke, or death
in adults with type 2 diabetes mellitus with known heart disease.

Global Market:
According to the Novo Nordisk annual report, the global sale of Victoza was recorded at USD
1.80 Billion in 2022. It is estimated that the market size for liraglutide drugs is expected to grow
at a CAGR of 5.8% from 2021 to 2028.1,2

Potential Generic Manufacturers in INDIA:

The Indian market for Liraglutide is estimated to be INR 27 Crores in the year 2023.There are no
current biosimilars of Liraglutide available in the market. But many market players are good in this
therapeutic area, including Biocon.

1. https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/annual_report/2023/novo-nordisk-annual-report-2022.pdf

2. https://dataintelo.com/report/global-liraglutide-drugs-market/

46 | Page IMPENDING PATENT CLIFF 2022-2030

Cosentyx
Innovator Company: Novartis
API/Salt/Composition: Secukinumab
Pharmacological Classification:
Monoclonal Antibodies

Dosage Form:
Subcutaneous Injection

Dosage Strength:
● Injection: 150 mg/mL solution in a
single-use Sensoready® pen
● Injection: 150 mg/mL solution in a
single-use prefilled syringe
● For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution for
healthcare professional use only

Patent Number and Expiration Date:

● US7807155 Feb 09, 2030
There are 47 patents protecting this drug of Novartis.

Indications:
● Moderate to severe plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy.
● Adults with active psoriatic arthritis (PsA).
● Adults with active ankylosing spondylitis (AS).

Global Market: The Global Drug sales of Cosentyx stood at USD 4.78 Billion in 2022. And is
expected to grow at a CAGR growth rate of 5.80% by 2029. 1,2

Potential Generic Manufacturers in INDIA: There are no currently other biosimilars in the
market for Secukinumab. Glenmark, Dr Reddy’s, and Sun Pharma are among the top companies
in India that manufacture medicines in plaque psoriasis and ankylosing spondylitis.

1. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-cosentyx-1127410/

2. https://www.databridgemarketresearch.com/reports/global-secukinumab-market

47 | Page IMPENDING PATENT CLIFF 2022-2030

Avastin

Innovator Company:

Genentech

API/Salt/Composition:

Bevacizumab

Pharmacological Classification:

Monoclonal Antibody and Anti-Angiogenesis Drug

Dosage Form: Intravenous injection

Dosage Strength:

● 100mg/4 mL

Patent Number and Expiration Date:

● US20150147317A1 2022

There are 24 High confidence patents covering Genentech’s Avastin.

Indications:

Metastatic Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC), Glioblastoma (GBM), Metastatic
Kidney Cancer (mRCC), Advanced Cervical Cancer (CC), Ovarian Cancer (OC), Hepatocellular Carcinoma
(HCC)

Global Market:

The Global Drug Sale of Avastin is USD 2.32 Billion in 2022. As the patent is expiring the market of
Bevacizumab is estimated to reach USD 12.96 Billion in 2030 and is expected to CAGR of 9.2%. 1,2

Potential Generic Manufacturers in INDIA:

Indian market for Bevacizumab was estimated to be INR 223 Cr in the year 2018. Mumbai-based
Reliance Life Sciences has launched a biosimilar and is the first company that brings the first biosimilar
of Bevacizumab to India.

1. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-avastin-1127427/

2. https://www.databridgemarketresearch.com/reports/global-bevacizumab-market

48 | Page IMPENDING PATENT CLIFF 2022-2030

Enbrel

Innovator Company: Amgen

API/Salt/Composition: Etanercept

Pharmacological Classification:

Anti-TNFs or TNF blockers

Dosage Form:

Subcutaneous Injection

Dosage Strength:

● 2 mg/0.05 mL

Patent Number and Expiration Date:

● US8163522B1 April 24, 2029

● US8063182B1 November 22, 2028
● NL300129I2 July 02, 2023
Amgen holds 19 active patent applications and many approved patents

Indications:

● Moderate to severe Rheumatoid Arthritis

● Psoriatic Arthritis
● Moderate to severe Plaque Psoriasis
● Ankylosing Spondylitis
● Moderate to severe polyarticular Juvenile Idiopathic Arthritis

Global Market:

The global market size of Enbrel was USD 4.12 Billion in 2022 and is expected to grow up to 20.8 billion
USD at a CAGR growth rate of 3.3%. 1,2

Potential Generic Manufacturers in INDIA:

Indian Companies Like Intas, Cipla, Taj Pharma, Reliance Life Sciences, and Lupin have Launched their
biosimilar as Intacept, Etaacept, Enbrol, Etanerrel, and Rymti respectively for Pfizer’s Etanercept.

1. https://www.statista.com/statistics/312378/enbrel-global-revenues-by-region-amgen/

2. https://www.globenewswire.com/en/news-release/2022/05/10/2440034/0/en/At-CAGR-of-3-3-Global-Etanercept-Market-Size-Share-2022-2028-Projected-to-Hit-at-USD-20-8-Billion

-Etanercept-Industry-Trends-Value-Analysis-Forecast-Report-by-Facts-Factors.html

49 | Page IMPENDING PATENT CLIFF 2022-2030

OxyContin

Innovator Company: Purdue Pharma LLP

API/Salt/Composition: Oxycodone
Pharmacological Classification:
Opiate (narcotic) analgesics

Dosage Form: Tablets

Dosage Strength:
● Tablets: 10mg, 20mg, 40mg, 80mg, 160mg

Patent Number and Expiration Date:

● US10696684 March 30, 2025
● US10407434 March 30, 2025
● US9522919 March 30, 2025
● US9073933 March 30, 2025

Oxycodone hydrochloride has 602 patent family members in forty-nine countries. There are twelve
drug master file entries for oxycodone

Indications:

● Moderate to Severe Pain

Global Market:

The Oxycodone Market Size is projected to exceed value to USD 8.9 Billion by 2022 this marks
a significant increase from its current value of USD 5.11 Billion in 2023 and is expected to grow
at a CAGR of 5.7% between 2023 to 2033.1,2

Potential Generic Manufacturers in INDIA:

Taj Pharma is the only Oxycodone generic manufacturer in India at present.

1. https://finance.yahoo.com/news/oxycodone-market-estimated-cross-worth-163000919.html

2. https://www.futuremarketinsights.com/reports/oxycodone-market

50 | Page IMPENDING PATENT CLIFF 2022-2030

 Lantus
Innovator Company:

Sanofi

API/Salt/Composition:

Insulin Glargine

Pharmacological Classification:

Long-acting insulin

Dosage Form: Subcutaneous Injection

Dosage Strength:

● 100Units/ml

Patent Number and Expiration Date:

● US8048854B2 July 05, 2027

● EP2575865B1 May 27, 2031

Sanofi has filed 74 patent applications in 2018, on Lantus in the U.S. with the aim of preventing
competition for a total of 37 years.

Indications:

Paediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus

Global Market:

Lantus was Sanofi's second best-selling pharmaceutical product in 2022 according to the company's
latest annual financial report and generated USD 2.3 Billion, is expected to reach USD 6.2 Billion by 2028,
growing at a CAGR of 18 % during the forecast period (2022-2028).1,2

Potential Generic Manufacturers in INDIA:

Indian market for Insulin Glargine was estimated to be USD 376 Million in the year 2020.Biocon has
launched its biosimilar of Insulin Glargine with the name BASALOG in India and some other countries
like Malaysia, Algeria, Morocco, Tanzania, Colombia, and Kazakhstan.

1. https://www.statista.com/statistics/266506/sanofi-top-pharmaceutical-products/
2. https://www.coherentmarketinsights.com/market-insight/insulin-glargine-market-5231

51 | Page IMPENDING PATENT CLIFF 2022-2030

Lucentis

Innovator Company: Genentech (Roche)

API/Salt/Composition: Ranibizumab

Pharmacological Classification:

Vascular Endothelial Growth Factor A

(VEGF-A) Antagonists

Dosage Form: Intravitreal Injection

Dosage Strength:

● Single-use prefilled syringe 0.05 mL for

intravitreal injections: -
10 mg/mL solution (LUCENTIS 0.5 mg)
6 mg/mL solution (LUCENTIS 0.3 mg)
● Single-use glass vial 0.05 mL for intravitreal
injections: -
10 mg/mL solution (LUCENTIS 0.5 mg)
6 mg/mL solution (LUCENTIS 0.3 mg)

Patent Number and Expiration Date:

● DE202012011260U1 November 24, 2022

Lucentis is covered with 36 US Patents and 9 High Confidence Patents.

Indications:

Wet age-related macular degeneration (Wet AMD), Diabetic retinopathy and diabetic macular oedema
(DR and DME), Myopic choroidal neovascularisation (mCNV), Macular oedema following retinal vein
occlusion (RVO)

Global Market:

Lucentis’ global sales of USD 1.8 billion in 2022. The age-related macular degeneration market size was
valued at USD 9.84 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR)
of 6.9% from 2022 to 2030.1,2

Potential Generic Manufacturers in INDIA:

Sun Pharmaceuticals and Intas Pharmaceuticals received the grant to manufacture Ranibizumab and
launched biosimilars such as Oceva and Razumab.

1. https://www.novartis.com/investors/financial-data/product-sales

2. https://www.grandviewresearch.com/industry-analysis/age-related-macular-degeneration-market-report

52 | Page IMPENDING PATENT CLIFF 2022-2030

Symbicort

Innovator Company: AstraZeneca

API/Salt/Composition:

Budesonide/Formoterol

Pharmacological Classification:

Long-acting beta-agonists

Dosage Form: Inhalation Aerosol

Dosage Strength:

● Budesonide (80 or 160 mcg) + Formoterol (4.5mcg)

Patent Number and Expiration Date:

● US20210069215A1 January 29, 2023

There are 11 patents protecting this drug and one Paragraph IV challenge.
This drug has 258 patent family members in 43 countries.
Indications:

● Asthma
● Chronic Obstructive Pulmonary Disease (COPD)

Global Market:

The global revenue of Symbicort was USD 2.54 Billion in 2022, global smart inhaler market size is
estimated to be valued at USD 4.86 Billion by 2028, growing at a promising CAGR of 18.01% from 2023
to 2028. 1,2,3

Potential Generic Manufacturers in INDIA:

Indian market for Budesonide/Formoterol was estimated to be USD 226.4 Million in the year 2021. Cipla,
Lupin, Zydus Cadila, Macleods Pharma, Glenmark, Mankind, Intas, and Sun Pharmaceuticals are the
companies that have launched their generics in the Indian Market.

1. https://www.fiercepharma.com/special-reports/top-10-drugs-losing-us-exclusivity-2023

2. https://www.marketdataforecast.com/market-reports/smart-inhaler-market

3. https://www.astrazeneca.com/content/dam/az/PDF/2022/fy/Full-year-and-Q4-2022-results-announcement.pdf

53 | Page IMPENDING PATENT CLIFF 2022-2030

Crestor
Innovator Company: AstraZeneca

API/Salt/Composition: Rosuvastatin

Pharmacological Classification:

HMG-CoA Reductase Inhibitors (Statins)

Dosage Form: Tablet

Dosage Strength:

● Tablets: 5 mg, 10 mg, 20 mg, and 40 mg

Patent Number and Expiration Date:

● US6316460B1 August 04, 2020

● US6858618 June 17, 2022

This drug has 43 patent family members in thirty-four

countries. There are 42 drug master file entries for the
compound.

Indications:

● Risk of Stroke, Myocardial Infarction and arterial revascularisation

● As an adjunct to diet to LDL-C
● As an adjunct to diet for the treatment of adults with:
○ Primary Dysbetalipoproteinemia.
○ Hypertriglyceridemia

Global Market:

Crestor, Rosuvastatin had already become the number one lipid-lowering drug in the world with a sales
value of over USD 6 billion in 2012. In 2022, the revenue amounted to 1.05 billion U.S. dollars and is
expected to grow at a CAGR of 6% from 2022 to 2030. 1,2,3

Potential Generic Manufacturers in INDIA:

Like many other drugs rosuvastatin also have its generics in the Indian Market from Sun Pharma, USV
Ltd, Torrent, Lupin, Dr Reddy’s, Cipla, Eris Lifesciences and Intas.
1. https://www.reportsanddata.com/report-detail/rosuvastatin-market

2. https://dataintelo.com/report/global-rosuvastatin-market/

3. https://www.astrazeneca.com/content/dam/az/PDF/2022/fy/Full-year-and-Q4-2022-results-announcement.pdf

54 | Page IMPENDING PATENT CLIFF 2022-2030

Lyrica

Innovator Company: Pfizer

API/Salt/Composition:

Pregabalin

Pharmacological Classification: Alpha-2 Delta Ligand

Dosage Form:

Capsule/Oral Solution

Dosage Strength:

● Capsules: 25mg, 50mg, 75mg, 100mg, 150mg,

200mg, 225mg, 300mg
● Oral Solution: 20mg per ml

Patent Number and Expiration Date:

● US8044227B2 October 10, 2028

There are three patents protecting this drug and two Paragraph IV challenges. There are forty-one drug
master file entries for the compound.
Indications:

● Fibromyalgia
● Diabetic Nerve Pain
● Spinal Cord Injury Nerve Pain
● Pain After Shingles
● Partial Onset Seizure

Global Market:

Worldwide total Lyrica revenue in 2018 was USD 1.13 Billion, with an expected projected value of USD
1.12 Billion in 2023, and is expected to grow at a CAGR of 7.67%, to reach a staggering USD 1.89 Billion
by 2030. 1

Potential Generic Manufacturers in INDIA:

Indian market for Pregabalin was estimated to be USD 244 Million 2022. Dr Reddy's Laboratories is one
of the leading manufacturers and suppliers globally for Pregabalin API. Sun Pharmaceuticals, Torrent,
Intas, Unichem, La Renon, Icon and IPCA have Pregabalin generics in India.

1. https://www.researchandmarkets.com/report/pregabalin

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Xarelto
Innovator Company: Janssen Pharmaceuticals/Bayer

API/Salt/Composition: Rivaroxaban

Pharmacological Classification:

Factor Xa Inhibitors

Dosage Form: Tablets/Oral Suspension

Dosage Strength:

● Tablets: 2.5mg, 10mg, 15mg, 20mg

● Oral Suspension: 1mg/ml

Patent Number and Expiration Date:

● US7157456 August 28, 2024

This drug has 156 patent family members in 47 countries. There has been multiple litigation on patents
covering XARELTO.

Indications:

● Risk of Stroke and Systemic Embolism, Deep Vein Thrombosis (DVT) & Pulmonary Embolism
(PE), Prophylaxis of DVT which may lead to PE, Venous Thromboembolism (VTE) and recurrent
VTE, Prophylaxis of Venous Thromboembolism (VTE)
● Thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease

Global Market:

Xarelto is approved in over 130 countries by respective regulatory bodies. The U.S. global rivaroxaban
market size was valued at USD 5.6 Billion in 2017, 7.4Billion in 2022 and is expected to witness a CAGR
of 1.5% over the forecast period (2018 – 2026) on account of patent expiry during the forecast period. 1,2

Potential Generic Manufacturers in INDIA:

Like Pregabalin, For Rosuvastatin is also Dr Reddy’s one of the leading manufacturers and suppliers
globally for Rivaroxaban API. Zydus Cadila, Cheminnova Lifesciences, Alniche Life Sciences, Cadila,
Macleods, Tas Med, Conatus, and HAB Pharma are some companies that have their generics in India.

1. https://www.drugdiscoverytrends.com/50-of-2022s-best-selling-pharmaceuticals/

2. https://www.coherentmarketinsights.com/market-insight/rivaroxaban-market-1962

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5. GENERIC PHARMACEUTICAL INDUSTRY
5.1 Overview and Market Size of Global Generic Pharmaceutical Industry
The global generic pharmaceutical market is a significant segment of the overall pharmaceutical
industry. Generic drugs are copies of brand-name drugs that have lost their patent protection.
These drugs are bioequivalent to the original brand-name drugs and offer the same therapeutic
effects but at lower costs. The global generic pharmaceutical market has been experiencing
steady growth over the years. Factors such as the expiry of patents on branded drugs,
increasing healthcare costs, the need for affordable medications, and growing demand for
generic drugs in emerging economies have been driving this growth. According to a report by
Grand View Research, the global generic drugs market was valued at approximately $228 billion
in 2020 and is expected to reach a value of $380 billion by 2030, growing at a compound annual
growth rate (CAGR) of around 6.2% during the forecast period.
The global generic pharmaceutical market is highly competitive, and several major players
operate on a global scale. These companies have established themselves as leaders in the
generic drug industry, supplying a wide range of affordable medications worldwide. Below are
some of the major global generic pharmaceutical players:
1. Teva Pharmaceutical Industries Ltd. (Israel)
2. Mylan N.V. (United States)
3. Sandoz International GmbH (Switzerland)
4. Sun Pharmaceutical Industries Ltd. (India)
5. Dr Reddy's Laboratories Ltd. (India)
6. Lupin Limited (India)
7. Cipla Limited (India)
8. Aurobindo Pharma Limited (India)
9. Zydus Cadila (India)
10. Torrent Pharmaceuticals Ltd. (India)
11. Hikma Pharmaceuticals PLC (Jordan)
12. Endo International PLC (Ireland)
13. Fresenius Kabi AG (Germany)
14. Apotex Inc. (Canada)
15. STADA Arzneimittel AG (Germany)

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These companies have a global presence, extensive product portfolios, and established
distribution networks. They supply generic drugs to various markets, including the United
States, Europe, Asia, Africa, and Latin America. Additionally, some of these companies also
engage in research and development (R&D) activities to develop new generic formulations and
enhance existing products.
5.2 Indian Generic Pharmaceutical Industry
The Indian generic pharmaceutical industry is one of the largest and fastest-growing sectors in
the country. It has gained significant prominence both domestically and globally due to its cost-
effective production capabilities and high-quality generic drugs. The Indian generic
pharmaceutical market has witnessed remarkable growth over the years. As per the
Department of Pharmaceutical’s Annual report 2022-23, the total annual turnover of
Pharmaceuticals in the fiscal year 2021-22 in India was approximately USD 42.34 Bn (Exhibit:9)
and the pharmaceutical sector contributed around 1.32% of the Gross Value Added (at 2011-
12 constant prices) of the Indian Economy in 2020-21
Exhibit 9: Indian Pharma Industry Revenues growth over the last years

Source: Department of Pharmaceutical Annual report 2022-23

India plays a significant role in the global generic pharmaceutical market. Indian pharmaceutical
industry also plays significant role globally. India has the highest number of United States Food
and Drug Administration (USFDA) compliant Pharma plants outside of USA. As per the Fiscal
year 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more
than 600 USFDA registered manufacturing sites, constituting nearly 12.5% of all registered
manufacturing sites operating outside US. There are 500 API manufacturers contributing about

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8% in the global API Industry. India is the largest supplier of generic medicines with 20% share
in the global supply by manufacturing 60000 different generic brands across 60 therapeutic
categories. Access to affordable HIV treatment from India is one of the greatest success stories
in medicine. India is one of the biggest suppliers of low-cost vaccines in the world. The country
is recognized as the "pharmacy of the world" due to its substantial production and export of
generic drugs. Here are some key aspects of India's contribution:

Cost-Effective Production: India has a competitive advantage in terms of cost-effective

production capabilities. The country has a vast network of pharmaceutical manufacturers that
can produce high-quality generic drugs at lower costs compared to many other countries.
Large Export Market: India is one of the largest exporters of generic drugs worldwide. Indian
pharmaceutical companies export generic drugs to various countries, including the United
States, Europe, Africa, and other emerging markets. Indian generics are known for their
affordability and accessibility. With Indian pharmaceutical exports reaching $25.4 billion in
FY23, the future looks promising for the Indian pharmaceutical industry as it continues to
contribute significantly to global healthcare. Interestingly, India exports approximately 30% of
its total pharmaceutical exports to the US.

Strong Domestic Market: India also has a robust domestic market for generic pharmaceuticals.
The country has a large population and a growing middle class, resulting in increased demand
for affordable medications. This domestic market contributes significantly to the overall sales
and growth of the Indian pharmaceutical industry.
1. Regulatory Compliance: Indian generic pharmaceutical companies adhere to
international quality standards and regulatory requirements. They follow the guidelines
set by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European
Medicines Agency (EMA), and World Health Organization (WHO).
2. Research and Development (R&D): Indian pharmaceutical companies invest in R&D
activities to develop new generic drugs and improve existing formulations. This focus
on innovation enables them to bring cost-effective alternatives to the market,
expanding the range of available generic medications.
Competitive Landscape: The industry exhibits intense competition among both domestic and
multinational companies. The major players compete based on factors such as product quality,
pricing, research and development capabilities, manufacturing capacities, distribution
networks, and regulatory compliance. This competition drives innovation and cost efficiency in
the industry.
Regulatory Environment: The Indian pharmaceutical industry operates under the regulation of
several authorities, including the Central Drugs Standard Control Organization (CDSCO) and the
Drug Controller General of India (DCGI).

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5.3. PESTEL Analysis of Indian Pharmaceutical Industry
Understanding the political, economic, sociocultural, technological, environmental, and legal factors is
vital for assessing the opportunities and challenges in the pharmaceutical market in India. The industry
must adapt to changes in these external factors, navigate regulatory requirements, leverage technology
advancements, and align their strategies with the evolving needs of the pharmaceutical industry to
succeed in the global market.

Exhibit 10 Below Table summarizes the PESTEL Analysis for the Indian Pharmaceutical Industry:

Exhibit 10 : PESTEL Analysis of India CRO Market

5.3.1. Political

The political landscape in is quite stable with a government which believes in promoting the Indian
Pharmaceutical industry at a global level. The government has consistently raised the budget spending
on healthcare which has gone up by 13 per cent to Rs 89,155 crore in FY24. Of this, Rs 2,980 crore has
been earmarked for healthcare research. Department of Pharmaceuticals under the aegis of Ministry of
Chemicals and Fertilizers, Government of India has been running various schemes under the initiative
“Strengthening of Pharmaceutical Industry (SPI)", with a total financial outlay of Rs.500 Cr (USD 60.9
million) for the period from FY 21-22 to FY 25-26. The key regulatory bodies overseeing the industry are
the Department of Pharmaceuticals (Ministry of Chemicals and Fertilizers), Central Drugs Standard
Control Organization (CDSCO) and the Ministry of Health and Family Welfare. The regulatory scenario
in India, including drug approval processes, clinical trial regulations, and intellectual property protection
has significantly improved significantly post 2014. Further progressive and industry friendly changes in
government policies, regulations, and the enforcement of ethical guidelines are going to positively
influence the operational and legal frameworks within which pharmaceutical industry operate. The

60 | Page IMPENDING PATENT CLIFF 2022-2030

government is planning to table New Drugs, Medical Devices and Cosmetics Bill, 2023, in the Indian
Parliament in the upcoming session which seeks to regulate “the import, manufacture, distribution and
sale of drugs, medical devices and cosmetics; and ensure their quality, safety, efficacy, performance and
clinical trial of new drugs and clinical investigation of investigational medical devices and clinical
performance evaluation of new in vitro diagnostic medical device including AYUSH drugs, medical
devices and cosmetics with the objective of highest possible regulatory standards and a transparent
regulatory regime and to repeal the Drugs and Cosmetics Act, 1940.

5.3.2. Economical

India's economic growth and overall investment in healthcare and pharmaceutical sectors play a
significant role in the growth of the CRO market. The Indian economy is expected to grow at an average
rate of 6.7 percent till 2026 fiscal. Per capita income of India is steadily increasing implying more
spending on healthcare specifically by middle class and rich Indians. This also means that pharmaceutical
companies will have to invest more in R&D to understand the health profile of their consumer segment.
As per a latest report by FICCI (refer Exhibit 11) the total Market size of Indian Pharmaceutical industry
is expected to reach US$130 bn by 2030.In addition, India's comparatively lower labour costs and
operational expenses contributes to the growth of the Indian Pharmaceutical market. The Government
has allowed up to 100 percent FDI through automatic route to Greenfield pharmaceutical projects. For
Brownfield projects also Indian government has permitted the FDI allowed is up to 74% through
automatic route and beyond that through government approval.

Exhibit 11: Indian Pharma’s ambition 2030 (Source FICCI report 2021)

Source: FICCI-EY Report 2021

5.3.3. Social

India has a huge population of 1.4 billion with one of highest disease burden. There is an urgent need
for new drugs, therapies medical devices and healthcare facilities to cater to increasing healthcare need
of this populations. The prevailing lifestyle of Indians specially in urban areas has resulted in life long
chronic lifestyle disease. There is also a big chunk of old and elderly people above 60 years of age
(numbering about 138 million) in this population who require specialized healthcare services. The
availability and quality of healthcare infrastructure in India impact the capabilities and attractiveness of
the pharmaceutical market. State of Art manufacturing plant and research and development centre

61 | Page IMPENDING PATENT CLIFF 2022-2030

approved by international regulatory agencies, adequate healthcare facilities, medical and para medical
resources, well qualified pharmacy and life sciences educated workforce etc. contribute to create a
conducive environment for the growth of Indian Pharmaceutical industry.

5.3.4. Technological

Indian Pharma industry has been gradually acknowledging the rapid advancements in technology and
are adopting technologies such as Artificial intelligence, Machine learning, High throughput drug
screening, electronic data capture, cloud computing and big data analytics. Many companies have
started focussing on high end Precision medicine and Gene Editing based products which are crucial to
pharmaceutical development. In future, these technologies could become the turning point in the quest
to discover new drugs. Indian pharma industry needs to stay updated with emerging technologies to
enhance their capabilities, improve efficiency, and offer innovative solutions to pharmaceutical clients.

5.3.5. Environmental

Increasing environmental awareness and regulations regarding waste management, biocontainment,

local municipality rules and environmental impact influence the pharmaceutical industry. The
pharmaceutical companies need to ensure compliance with applicable environmental regulations and
adopt sustainable practices.

5.3.6. Legal

The Indian Patents Act, 1970, governs the granting and protection of patents. The Patents Act
governs the grant, administration, and revocation of patents in India. It allows for the grant of
product patents for inventions that are novel, non-obvious, and have industrial applicability.
However, there are specific provisions within the Act to prevent the grant of patents for certain
categories of inventions, including those related to traditional knowledge and pharmaceutical
substances. India has IPR laws in place to protect pharmaceutical innovations and ensure a
balance between promoting innovation and providing affordable access to medicines. The
Patents Act, 1970 (Act) is an example of a well-balanced legislation, which balances the
interests of the pharmaceutical industry as well as the public. The Act encourages the
pharmaceutical industry to come up with 'actual inventions' by excluding incremental
inventions from the purview of patentability, thereby safeguarding public health. Such
provision ensures that essential medicines remain accessible to the public at affordable price.
The United Nations Secretary General's High-Level Panel on Access to Medicines Report, 2016
stated as follows in respect of India's Patent Laws: 'India is the most often cited example of how
a government used their freedom to adapt domestic intellectual property laws to meet national
objectives”. The legal framework and regulations also included The Acts like Drugs and
Cosmetics Act 1940 and Rules 1945, schedule Y for clinical research by Central Drugs Standard
Control Organisation or CDSCO and the ICMR and GCP guidelines covers a set of regulations to
assure safety, protection and welfare of subjects in conducting clinical trials in India. In addition,
Clinical Trial Rules, 2019 issued by Government of India has comprehensive set of rules which
regulates the process for approval of medicines in India. These rules cover new drugs,
investigational new drugs for human use, clinical trials, bio equivalence studies, bio availability
studies and provide for the constitution, registration and role of the ethics committees in a
clinical trial. India pharmaceutical industry is also governed by The Drugs and Magic Remedies
(Objectionable Advertisements) Act, 1954 which prohibits the pharmaceutical companies from

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advertising and promotion of drugs by making false or misleading claims about their efficacy or
safety. On the price front, the National Pharmaceutical Pricing Authority (NPPA) under the aegis
of Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers regulates the prices of
essential medicines through the Drug Price Control Order (DPCO)] to ensure their availability
and affordability.

5.4. SWOT Analysis of Indian Pharmaceutical Industry:

As per the Annual report of Department of Pharmaceuticals for the year 2022-2023, the
pharmaceutical industry contributes around 1.32% to the gross domestic product (GDP) of
the India. The Indian pharmaceutical industry is currently the world’s third-largest in volume
and tenth-largest in size. A SWOT Analysis of this industry in Exhibit 12 can help policy
makers in making informed decisions on the interventions for future.
Exhibit 12 : SWOT Analysis of Indian Pharmaceutical Industry

5.4.1. Strengths of Indian Pharmaceutical Sector:

● Large and Diverse Market: The Indian pharmaceutical industry benefits from a large
and diverse domestic market, providing opportunities for a wide range of products and
therapeutic areas. The overall scale of the industry (including medications and medical

63 | Page IMPENDING PATENT CLIFF 2022-2030

 devices) is about US$43 billion and is currently seeing a growth pace of 7–8% in the drug
market. Net exports (medicines and medical equipment) amount to about US$20 billion,
of which about 90% are medicines (DoP, 2022). Branded generic products lead the
Indian pharmaceutical industry, contributing 70% of the market share in revenues. The
generic drug market contributes 21%, while over-the-counter contributes 9% of the
Indian pharmaceutical market of overall US$ 20 billion revenue.

● Cost Advantage: India has a competitive advantage in terms of cost of production,

including lower labour costs and affordable manufacturing infrastructure. This allows
Indian pharmaceutical companies to offer products at competitive prices globally.

● Skilled Workforce: India has a strong pool of scientific and technical talent, including
skilled researchers, scientists, and professionals in the pharmaceutical field. This talent
pool contributes to the industry's research and development capabilities.

● Generic Drug Manufacturing Hub: India is one of the leading global manufacturers of
generic drugs, supplying a significant portion of the world's generic medications. Indian
generic medications account for 20% of global exports, making the country the world’s
top provider of generic pharmaceuticals in volume. Indian products are shipped to over
200 countries around the globe, with Japan, Australia, West Europe and the US as the
main destinations.

● Regulatory Exposure : As of April 2023, Indian pharmaceutical companies have secured

6316 market authorizations granted by the US Food and Drug
Administration (USFDA)(Source:www.thehindubusinessline.com). In addition to a large
number of WHO approved manufacturing Plants, there has been a consistent increase
in the registration of manufacturing sites in India approved by the US and European
regulators as well.

5.4.2. Weaknesses of Indian Pharmaceutical Sector

● Regulatory Complexity & Challenges: Regulatory frameworks and policies can change,
both domestically and internationally, impacting market access, pricing, and compliance
requirements. Adapting to evolving regulations and meeting global quality standards
can be a challenge for the industry. Companies need to navigate through various
regulatory processes, including drug approvals, pricing controls, and intellectual
property rights.

● Quality Concerns: Maintaining consistent quality and compliance with Good

Manufacturing Practices (GMP) is crucial for the reputation and success of
pharmaceutical companies. Instances of non-compliance or quality issues can lead to
regulatory actions, import bans, and damage to the industry's image. While India has
many reputable pharmaceutical manufacturers, the industry has also faced concerns

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 regarding the quality and compliance of some products. The Indian pharmaceutical
market has faced challenges with counterfeit and substandard drugs. These products
not only pose risks to patient safety but also harm the reputation of the industry.
Strengthening regulatory oversight and implementing robust supply chain controls are
necessary to address this issue. Recent instances of non-compliance with quality and
regulatory standards have brought India into media’s scrutiny from regulatory
authorities.

5.4.3. Opportunities for Indian Pharmaceutical Sector:

● Growing Domestic Market: The Indian pharmaceutical market continues to grow due
to factors such as increasing healthcare awareness, rising disposable income, and
expanding healthcare infrastructure. This presents opportunities for both domestic and
international pharmaceutical companies to cater to the growing demand.

● Increasing Focus on Research and Development: The Indian pharmaceutical industry is

gradually shifting its focus towards research and development activities. Investments in
R&D can lead to the development of innovative drugs and novel therapies, providing
opportunities for growth and differentiation.

● Expansion into Emerging Markets: In the years between 2022-30, the pharmaceutical
sector in India will undergo landmark changes as a number of drugs are expected to go
off-patent and provide an opportunity for the entry of generic products. Expiry of
patents is very promising for the Indian generic drug market as it is expected to expand
and grow further with inclusion of these new drugs. Indian pharmaceutical companies
can explore opportunities in these markets, where there is a growing demand for
affordable healthcare and generic medications. Expansion into these markets can
contribute to revenue growth and market diversification.
5.4.4 Threats for Indian Pharmaceutical Sector

● Pricing Pressure: Price controls and regulations in India, both for domestic and export
markets, can put pressure on the profitability of Indian pharmaceutical companies. The
global pharmaceutical industry, including India, faces pricing pressure due to factors
such as healthcare cost containment measures, competitive markets, and the rise in
price of APIs and excipients. Price erosion can impact profitability and sustainability of
Indian Pharmaceutical companies.

● Intellectual Property Challenges: Intellectual property rights and patent protection

continue to be a challenge for the Indian pharmaceutical industry. Patent litigation and
potential restrictions on the production and export of generic drugs can impact the
industry's competitiveness. Striking a balance between promoting generic drug

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 manufacturing and protecting intellectual property rights remains an addressable
subject.

● Research and Development (R&D) Investment: Indian generic business investors have
limited risk appetite. Limited R&D spending, compared to global counterparts, hampers
the development of new drugs and therapies in India. Therefore; while the Indian
pharmaceutical industry has made immense progress in generic pharmaceutical
industry, there is still a need for increased investment in innovative research.

● Global Competition: Indian pharmaceutical companies face competition from both

domestic and international players. Global competition, particularly from countries like
China, can impact market share and pricing dynamics. Indian companies need to stay
competitive by investing in technology, innovation, and expanding their global presence
India faces competition from other countries, particularly in the generic drug
manufacturing sector. Countries like China and emerging Southeast Asian economies
also have competitive advantages in terms of cost and manufacturing capabilities.

5.5. Major Pharmaceutical Players in the Indian Market

The Indian generic pharmaceutical industry consists of numerous players, ranging from
large multinational companies to small and medium-sized enterprises. Some of the major
players in the industry include:

1. Sun Pharmaceutical Industries Ltd.

2. Cipla Limited
3. Dr Reddy's Laboratories Ltd.
4. Lupin Limited
5. Aurobindo Pharma Limited
6. Cadila Healthcare Limited
7. Torrent Pharmaceuticals Ltd.
8. Glenmark Pharmaceuticals Ltd.
9. Alkem Laboratories Ltd.
10. Biocon Limited

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 5.6. Major Therapeutic Areas Opportunities for Indian Generic Companies

The patent cliff will provide an opportunity to Indian generic companies to enter the US
and other regulated markets and produce more affordable versions of those medications.
It's important to note that while the patent cliff presents opportunities for Indian
companies, there are many challenges for Indian companies have to face in developing new
generic drugs. Indian companies seeking to manufacture or distribute generic drugs require
up-to-date information on any existing ANDAs and the exclusivity patents recognized by
the FDA. Gathering and organizing the FDA guidance along with drug technical data can be
challenging and must be kept current. These company need to comply with the appropriate
approval processes and demonstrate bioequivalence and therapeutic efficacy to ensure the
safety and effectiveness of their generic products before launch in global markets. This
presents several opportunities for Indian generic companies in various therapeutic areas.

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5.6.1. Cardiovascular diseases:
Global Market Size in 2020: USD 82 Billion

Expected Global Market Size in 2026: USD 110 Billion

Expected CAGR: 5%

Types of Conditions that come under the therapeutic area:

● Hypertension
● Dyslipidaemia Heart failure
● Ischemic heart disease
Key Drivers of the Global Cardiovascular Market:
Several factors contribute to the growth of the cardiovascular
therapeutic area. These include the rising prevalence of
cardiovascular diseases globally
● An ageing population,
● unhealthy lifestyles,
● increasing awareness about early diagnosis and treatment.
Additionally, advancements in drug therapies and innovations in medical devices for
cardiovascular interventions drive market growth.
Key Drug Classes in Cardiovascular Area: The global cardiovascular therapeutic area
encompasses various drug classes. Some of the key drug classes include:
● Antihypertensive agents (such as ACE inhibitors, beta-blockers, and calcium channel
blockers),
● Lipid-lowering agents (such as statins and PCSK9 inhibitors),
● Antiplatelet agents, anticoagulants, and heart failure medications (such as beta-
blockers and angiotensin receptor blockers)

Prominent Markets for Cardiovascular Drugs:

The global cardiovascular market is geographically diverse. North America, including the United
States, holds a significant market share, driven by a high prevalence of cardiovascular diseases
and robust healthcare infrastructure. Europe also accounts for a considerable portion of the
market, primarily due to the ageing population. The Asia-Pacific region, particularly countries
like China and India, is expected to witness substantial growth due to increasing awareness,
rising healthcare spending, and a growing patient population.
Competitive Landscape: The global cardiovascular market is highly competitive, with both
multinational pharmaceutical companies and generic drug manufacturers competing in this
space. Major pharmaceutical companies such as Pfizer, Novartis, AstraZeneca, Merck & Co.,
and Bristol Myers Squibb have a strong presence in the cardiovascular therapeutic area.
However, generic manufacturers, including Indian companies like Sun Pharma, Dr Reddy's, and
Lupin, also play a significant role in providing affordable cardiovascular medications.

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Emerging Therapies in Cardiovascular Area: The cardiovascular therapeutic area is witnessing
advancements in treatment approaches. There is an increasing focus on precision medicine,
targeted therapies, and innovative drug delivery systems. Additionally, research and
development efforts are underway to explore new therapeutic modalities like gene therapies
and regenerative medicine for cardiovascular conditions.
Challenges in the Cardiovascular Area: The cardiovascular therapeutic area faces challenges
such as stringent regulatory requirements, pricing pressures, and the need for rigorous clinical
trials to demonstrate efficacy and safety. Additionally, access to healthcare in developing
regions and compliance issues related to medication adherence remain areas of concern.
Overall, the global cardiovascular therapeutic area presents significant opportunities for
pharmaceutical companies, including generic manufacturers, as the demand for effective and
affordable cardiovascular treatments continues to rise. The market growth is driven by the
increasing prevalence of cardiovascular diseases and the need for improved management and
preventive strategies. Many patents for widely used cardiovascular drugs have expired or are
set to expire soon. This includes medications for high blood pressure, cholesterol management,
and antiplatelet agents. Indian generic companies can capitalize on these opportunities by
manufacturing and distributing generic versions of these drugs, providing affordable options to
patients. Several Indian generic companies have been actively working on Abbreviated New
Drug Application (ANDA) submissions in the cardiovascular therapeutic areas.
Below are some of reputed Indian generic companies that have been successfully involved in
developing generic versions of cardiovascular drugs and pursuing ANDA submissions:

1. Sun Pharmaceutical Industries Ltd

2. Dr. Reddy's Laboratories Ltd
3. Lupin Ltd.
4. Torrent Pharmaceuticals Ltd.
5. Zydus Cadila

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5.6.2 Central Nervous System Disorders:

Global Market Size in 2020: USD 83 Billion (Source: Statista)

Expected Global Market Size in 2026: USD 105 Billion. Expected CAGR: 4%

Types of Conditions that come under the therapeutic area:

● Alzheimer's disease
● Parkinson's disease
● Epilepsy
● Depression
● Anxiety disorder
● Schizophrenia, and
● Multiple sclerosis

Key Drivers of Global CNS Market: Overall, the global CNS therapeutic area presents significant
opportunities for pharmaceutical companies, including generic manufacturers. The market
growth is driven by the increasing prevalence of CNS disorders, advances in neuroscience
research, and the need for improved treatments.
Key Drug Classes in CNS area:
● Antidepressants
● Antipsychotics
● Anxiolytics
● Mood stabilizers
● Antiepileptic drugs
● Cognitive enhancers
● Neurodegenerative diseases

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Competitive Landscape: The CNS therapeutic area is highly competitive, with both
multinational pharmaceutical companies and generic manufacturers competing in this space.
Major pharmaceutical companies such as Johnson & Johnson, Pfizer, Novartis, Eli Lilly, and
AstraZeneca have a strong presence in the CNS market. Additionally, there are several
specialized biopharmaceutical companies and generic manufacturers that focus on CNS
disorders.
Challenges in CNS areas: The CNS therapeutic area faces challenges such as complex disease
mechanisms, the blood-brain barrier limiting drug delivery, high failure rates in clinical trials,
and the need for long-term safety and efficacy assessments. Additionally, the stigma associated
with mental health disorders and the high cost of treatment pose challenges for patients' access
to care.
Below are some of reputed Indian generic companies that have been successfully involved in
developing generic versions of nervous system disorder drugs and pursuing ANDA submissions:
1. Sun Pharmaceutical Industries Ltd
2. Dr. Reddy's Laboratories Ltd
3. Lupin Ltd.
4. Torrent Pharmaceuticals Ltd.
5. Zydus Cadila
6. Intas Pharmaceuticals
7. Aurobindo Pharmaceuticals

5.6.3. Oncology
Global Market Size in 2020: USD 150 Billion (Source: Statista)

Expected Global Market Size in 2026: USD 250 Billion

Expected CAGR: 8%

Types of Conditions that come under the therapeutic area:

The oncology therapeutic area encompasses various cancer
types, including
● Breast cancer
● Lung cancer
● Colorectal cancer
● Prostate cancer
● Leukaemia
● Lymphoma
● Melanoma

Each cancer type requires different treatment approaches

and has specific market dynamics.

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Key Drivers of the Oncology Market: Several factors contribute to the growth of the oncology
therapeutic area. These include the increasing prevalence of cancer worldwide, advancements
in cancer research and treatment, a growing ageing population, and the introduction of
innovative therapies such as targeted therapies, immunotherapies, and precision medicine
approaches. Additionally, rising awareness, early detection, and improving access to healthcare
services drive market growth.
Major Treatment Therapies:
● Chemotherapy
● Radiation therapy
● Surgery
● Targeted therapies
● Immunotherapies
● Hormonal therapies

Competitive Landscape: The global oncology market is highly competitive, with major
pharmaceutical companies actively involved in the development and commercialization of
oncology drugs. Key players in the industry include Roche, Novartis, Pfizer, Merck & Co., Bristol
Myers Squibb, AstraZeneca, and Johnson & Johnson, among others. Additionally, smaller
biopharmaceutical companies and generic manufacturers play a role in providing cost-effective
oncology therapies.

In terms of Emerging Therapies, the oncology therapeutic area is witnessing rapid

advancements, particularly in the field of targeted therapies and immunotherapies. Precision
medicine approaches, such as genomic profiling and liquid biopsies, are gaining prominence,
allowing for personalized treatment decisions.
Additionally, cell-based therapies like CAR-T cell therapy and gene therapies are emerging as
potential game-changers in certain cancer types.
Challenges: The oncology therapeutic area faces challenges such as high development costs,
complex regulatory pathways, increasing pricing pressures, and the need for extensive clinical
trials to demonstrate safety and efficacy. Additionally, access to innovative therapies and the
affordability of cancer treatments pose challenges in some regions.
The global oncology therapeutic area presents significant opportunities for pharmaceutical
companies, with strong market growth driven by the increasing incidence of cancer and
advancements in treatment options. The industry's focus is shifting towards precision medicine
and targeted therapies, providing personalized and effective cancer treatments. Below Indian
generic companies that have been involved in developing generic versions of oncology drugs
and have made multiple ANDA submissions:
1. Natco Pharma Limited
2. Cipla Limited
3. Glenmark Pharmaceuticals Limited

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 4. Aurobindo Pharma Limited
5. Intas Pharmaceuticals Ltd

5.6.4. Respiratory Disorders:

Global Market Size in 2020: USD 40 Billion (Source: Statista)

Expected Global Market Size in 2026: USD 55 Billion

Expected CAGR: 5%

Types of Conditions that come under the therapeutic

area:

The respiratory therapeutic area covers various respiratory conditions. Asthma and COPD are
the most prevalent respiratory diseases, affecting a large population globally. Other respiratory
conditions include
● Respiratory tract infections,
● Pulmonary arterial hypertension,
● Idiopathic pulmonary fibrosis, and
● Sleep apnea
Major Treatment Modalities in Respiratory Area:
● Corticosteroids
● Bronchodilators
● Combination therapies
● Immunomodulators
● Antibiotics
● Mucolytics
● Inhalers and Nebulizers

Prominent Markets for Respiratory Drugs: North America, particularly the United States,
accounts for a significant share of the global respiratory market due to a high prevalence of
respiratory conditions and a well-established healthcare system. Europe also holds a
considerable market share, driven by an aging population and environmental factors.
The Asia-Pacific region, including countries like China and India, is witnessing significant growth
due to improving healthcare infrastructure, rising pollution levels, and increasing awareness of
respiratory diseases.
Competitive Landscape: The global respiratory market is competitive, with both multinational
pharmaceutical companies and generic manufacturers operating in this space. Key players in
the market include GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, and Teva

73 | Page IMPENDING PATENT CLIFF 2022-2030

Pharmaceuticals. Generic manufacturers also play a role in providing affordable respiratory
medications.
Emerging Therapies in Respiratory Area: The respiratory therapeutic area is witnessing
advancements in treatment approaches. There is ongoing research and development to
explore innovative therapies, including biologics, gene therapies, and targeted therapies, for
respiratory conditions like severe asthma and cystic fibrosis.
The COVID-19 pandemic has significantly impacted the respiratory therapeutic area. The
demand for respiratory medications and devices surged due to the respiratory complications
associated with COVID-19. The development of vaccines and antiviral therapies targeting
respiratory infections has also gained prominence.
Additionally, digital health solutions, such as telemedicine and remote patient monitoring, are
being integrated into respiratory care.
Challenges: The respiratory therapeutic area faces challenges such as increasing healthcare
costs, regulatory complexities, and adherence to treatment regimens. Furthermore,
environmental factors such as air pollution and tobacco smoking contribute to the rising burden
of respiratory diseases.
Overall, the global respiratory therapeutic area presents significant opportunities for
pharmaceutical companies and generic manufacturers. The market growth is driven by the
increasing prevalence of respiratory conditions, environmental factors, and advancements in
treatment options. However, challenges related to pricing pressures, regulatory requirements,
and the impact of external factors like pollution remain important considerations in the
respiratory market
Below are a few examples of Indian generic companies that have been involved in developing
generic versions of respiratory drugs and pursuing ANDA submissions:
1. Cipla Limited
2. Sun Pharmaceutical Industries Ltd
3. Lupin Limited
4. Glenmark Pharmaceuticals Limited
5. Zydus Cadila

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5.6.5 Diabetes:
Global Market Size in 2020: USD 26.5 Billion (Source: Statista)
Expected Global Market Size in 2026: USD 42.4 Billion
Expected CAGR: 8.1%
Types of Conditions that come under the therapeutic area:
The diabetes therapeutic area covers conditions like Type-1
Diabetes and Type-2 Diabetes.
With the expiration of patents for various antidiabetic drugs,
Indian generic companies can play a significant role in providing
affordable options for patients with diabetes. This includes
generic versions of oral antidiabetic agents, insulin, and other
related medications. Indian generic companies have been
actively working on ANDA submissions in the diabetes therapeutic areas as well. Here are a few
examples of Indian generic companies that have been involved in developing generic versions
of diabetes drugs and pursuing ANDA submissions:

1. Biocon Ltd
2. Sun Pharmaceutical Industries Ltd
3. Dr Reddy's Laboratories Ltd
4. Lupin Limited
5. Torrent Pharmaceuticals Ltd
6. Zydus Cadila

5.6.6 Autoimmune Disorders:

Global Market Size in 2020: USD 62 Billion
Expected Global Market Size in 2026: USD 100 Billion
Expected CAGR: 8%
Types of Conditions that come under the therapeutic area:
The autoimmune diseases therapeutic area encompasses a
wide range of disorders, including
● Rheumatoid arthritis,
● Psoriasis,
● Systemic lupus erythematosus (SLE),
● Multiple sclerosis (MS),
● Inflammatory bowel disease (IBD),
● Type 1 diabetes, and others.

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Treatment Modalities in Autoimmune Therapeutic Area: Various treatment modalities are
used in the autoimmune diseases therapeutic area. These include immunosuppressants,
disease-modifying anti-rheumatic drugs (DMARDs), biological therapies, corticosteroids,
nonsteroidal anti-inflammatory drugs (NSAIDs), and targeted therapies. The use of biologics
and targeted therapies has been transformative in managing certain autoimmune disorders.
Prominent Markets of Autoimmune Therapeutic Area: North America, particularly the United
States, holds a significant share of the global autoimmune diseases market due to a high
prevalence of autoimmune disorders, advanced healthcare infrastructure, and favourable
reimbursement policies. Europe is also a prominent market, driven by increasing disease
prevalence and investments in research and development. The Asia-Pacific region, including
countries like China and India, is witnessing significant growth due to improving healthcare
infrastructure, increasing awareness, and rising disease burden.
Competitive Landscape: The global autoimmune diseases market is highly competitive, with
major pharmaceutical companies actively involved in the development and commercialization
of therapies. Key players include AbbVie, Johnson & Johnson, Pfizer, Novartis, Bristol Myers
Squibb, and Roche. Additionally, specialized biopharmaceutical companies and generic
manufacturers also play a role in providing affordable therapies for autoimmune diseases.
Emerging Therapies in Autoimmune Disorders Area: The autoimmune diseases therapeutic
area is witnessing advancements in treatment options. There is ongoing research and
development to explore novel drug targets, develop more specific and effective therapies, and
harness immunomodulatory approaches. Additionally, personalized medicine and precision
therapies are gaining attention in certain autoimmune disorders. The COVID-19 pandemic has
had an impact on the autoimmune diseases therapeutic area. Concerns about
immunosuppressive therapies and their effects on COVID-19 susceptibility and severity have
emerged. Additionally, disruptions in healthcare services and delays in clinical trials have
affected the development and access to new therapies
Challenges in the Development of Drugs in the area of Autoimmune Disorder: The
autoimmune diseases therapeutic area faces challenges such as complex disease mechanisms,
high development costs, regulatory requirements, and the need for long-term safety
assessments. Additionally, autoimmune disorders often require a multidisciplinary approach,
and managing comorbidities and treatment adherence can be challenging.
Below are of few of Indian generic companies that have been involved in developing generic
versions of autoimmune drugs and pursuing ANDA submissions:
1. Sun Pharmaceutical Industries Ltd
2. Lupin Limited
3. Dr. Reddy's Laboratories Ltd
4. Zydus Cadila
5. Torrent Pharmaceuticals Ltd

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5.7. Competitive Landscape for Indian Generic Companies

The industry exhibits intense competition among both domestic and multinational companies.
The major players compete based on factors such as product quality, pricing, research and
development capabilities, manufacturing capacities, distribution networks, and regulatory
compliance. This competition drives innovation and cost efficiency in the industry. In addition
to the innovator companies, the Indian generic companies face competition from other global
generic companies as well. The profiles of some of such global generic companies are
mentioned ahead in the report.

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 Teva
Headquarters: Petah Tikva, Israel

2021 generic drug sales: $8.99 billion

2020 generic drug sales: $9.31 billion

Change: -3%

About Company and their Mission:

Teva’s mission is to be a global leader in generics and biopharmaceuticals, improving the lives
of patients across the world. In a complex world, their mission is simple: to improve the lives of
patients across the globe. They believe that everyone should have access to quality medicines
whether it be for managing disease, fighting infections, or simply improving overall health. Teva
played a key role in developing the industry over the last 40 years. Teva sells more than 550
generic products and has more than 1,100 generics in its pipeline. Teva have strong operational
base, global infrastructure with 53 production sites globally.

Management Team:
Richard Francis President and Chief Executive Officer, Member of the Board of Directors
Richard Daniell Executive Vice President, European Commercial
Dr. Sven Dethlefs Executive Vice President, North America Commercial
Eric Drape Executive Vice President, Global Commercial
Dr Eric A. Hughes Executive Vice President, Global R&D and Chief Medical Officer
Focus Therapeutic Area:
Teva is focused on developing innovative medicines in core therapeutic areas in movement
disorders and neurodegeneration, Migraine, Neuropsychiatry and Respiratory.

Key Developments:
● Alvotech and Teva Secures U.S. License for Stelara® Proposed Biosimilar AVT04 on June 12,2023
● Teva and Natco Launched additional strengths for Generic Version of Revlimid® (lenalidomide)
Capsules, in U.S. on March 09, 2023
● Teva collaborated with Rimidi & Healthsnap to expand its Respiratory Digital Health Platform
on November 14, 2022.
● Teva launched First Market Generic Version of Narcan® (Naloxone Hydrochloride Nasal Spray),
in the U.S on December 22, 2021
● Teva launched generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide) on December
01, 2021
https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

www.tevapharm.com

https://www.tevapharm.com/news-and-media/latest-news/

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 Novartis’ Sandoz
Headquarters: Basel, Switzerland

2021 generic drug sales: $7.5

billion

2020 generic drug sales: $7.7 billion

Change: -2.6%

About Company and their Mission:

Sandoz is a global leader in generic pharmaceuticals and biosimilars and a division of the
Novartis Group. Sandoz contributes to society’s ability to support growing healthcare needs by
pioneering novel approaches to help people around the world access high-quality medicine.
Their global portfolio comprises approximately 1 000 molecules, covering a wide range of
therapeutic areas, which accounted for 2022 sales of USD 9.2 billion.

Management Team:
Richard Saynor Chief Executive Officer
Francisco Ballester President International
Martin Bischof Head of Ethics, Risk and Compliance
Focus Therapeutic Area:
Sandoz holds strong global positions in areas ranging from generic cardiovascular, central
nervous system (CNS), pain and ophthalmology to oncology and respiratory. Their broad
portfolio is backed by a range of state-of-the-art technologies, formulations and devices,
including prolonged-release and multiple-unit tablets, creams and gels, orodispersible films,
transdermal patches, lyophilized products, implants and inhalers.

Key Development:
● Sandoz received positive CHMP opinion for multiple sclerosis biosimilar natalizumab on July 24,
2023
● Sandoz made an announcement about the plan to build a biosimilar Technical Development
Centre in Slovenia to support future growth of biosimilar pipeline on July 20, 2023.
● Sandoz has launched Hyrimoz (adalimumab-adaz) high concentration formulation, in US on July
01, 2023.
● Sandoz’s application for marketing authorization for biosimilar denosumab accepted by EMA
on May 25, 2023.

https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

https://www.sandoz.com

https://www.sandoz.com/news/news-archive

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 Viatris
Headquarters: Pittsburgh, Pennsylvania

2021 generic drug sales:

$5.63 billion (excluding complex generics)

2020 generic drug sales:

$5.29 billion (excluding complex generics)

Change: +6%

About Company and their Mission:

Viatris are uniquely positioned to deliver their mission of empowering people worldwide to live
healthier at every stage of life. As a global healthcare company, improving access and
sustainably delivering high-quality medicine is our relentless pursuit. Viatris has more than 40
manufacturing facilities.

Management Team:
Robert J. Coury Executive Chairman
Scott A Smith Chief Executive Officer
Rajiv Malik President
Sanjeev Narula Chief Financial Officer

Focus Therapeutic Area:

Viatris offers quality treatment options across more than 10 major therapeutic areas covering
a wide variety of noncommunicable and communicable diseases like Cardiovascular, CNS and
Anesthesia, Dermatology, Diabetes and Metabolism, Eye Care, Gastroenterology, Immunology,
Infectious diseases, Oncology, Respiratory and Allergic and Women Healthcare.

Key Developments:
● Viatris seeked approval for a generic Tyrvaya on June 13, 2023
● Viatris and Mapi Pharma highlighted achieved results of Multiple Sclerosis Research at
American Academy of Neurology 75th Annual Meeting on April 24, 2023.
● Viatris got Approval for Emissions Reduction Targets by the Science Based Target initiative
(SBTi) on December 14, 2022
● Viatris completed their transaction of Biosimilars with Biocon Biologics on November 29, 2022.

https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

https://www.viatris.com/en

https://newsroom.viatris.com/press-releases

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 Fresenius Kabi
Headquarters: Bad Homburg, Germany

2021 generic drug sales: $3.72 billion

(estimate)

2020 generic drug sales: $3.58 billion

(estimate)

Change: +4%

About Company and their Mission:

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and
technologies for infusion, transfusion and clinical nutrition. Fresenius Kabi’s products and
services are used for the therapy and care of critically and chronically ill patients.

Management Team:
Sanjay Gupta Managing Director - South Asia
Kaushal Gupta Chief Financial Officer - South Asia
Focus Therapeutic Area:
Fresenius Kabi offers quality treatment options across various therapeutic areas like
Anaesthesia, Blood volume substitution, critical Illness, Diabetes Fluid management, Internal
and External Administration, Liver Insufficiency, Maldigestion/Malabsorption, Nutritional
Support, Oncology, Paediatrics, Renal Insufficiency, Transfusion medicine and cell therapies
and Biosimilars.

Key Developments:
● Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456 received positive CHMP opinion
on July 21, 2023.
● Fresenius Kabi has launched citrate free Idacio (adalimumab-aacf) biosimilar in the US on July
03, 2023.
● On July 12, 2023: Fresenius Kabi’s denosumab biosimilar FKS518 has showed positive clinical
trials results.
● Fresenius Kabi was awarded breakthrough technology agreement with premier Inc. for the
Ivenix Infusion System on May 23, 2023.
● Fresenius Kabi has launched its biosimilar Stimufend® (pegfilgrastim-fpgk) in the U.S. on
February 16, 2023.

https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

https://www.fresenius-kabi.com/

https://www.fresenius-kabi.com/news

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 Aspen Pharmacare
Headquarters: Durban, South Africa

2021 generic drug sales: $2.2 billion

2020 generic drug sales: $1.96 billion

Change: +12%

About Company and their Mission:

With a 170-year heritage, Aspen is a global specialty and branded multinational pharmaceutical
company with a presence in both emerging and developed markets. Aspen focuses on
marketing and manufacturing a broad range of post-patent, branded medicines and domestic
brands covering both hospital and consumer markets through their key business segments. The
key business segments are Manufacturing and Commercial Pharmaceuticals comprising
Regional Brands and Sterile Focus Brands. The manufacturing capabilities cover a wide variety
of product types including steriles, oral solid dose, liquids, semi-solids, biologicals and active
pharmaceutical ingredients.

Management Team:
Stephan Saad Group Chief Executive
Sean Capazorio Chief Financial Officer
Gus Attridge Group Chief Advisor
Richelle Crots Regional Chief Executive Officer, SA Commercial
Focus Therapeutic Area:
Aspen provides high quality, affordable medicines and products, focusing on niche therapeutic
areas like Anaesthetics, Thrombosis, High Potency & Cytotoxics, Nutraceuticals and some
regional brands for sleeping aid, respiratory analgesic, ARV and Uric Acid production inhibitor.

Key Developments:
● Aspen, Saudi Chemical Company holding and its subsidiary AJA Pharma enter into a
memorandum of understanding on March 07, 2023.
● Aspen, CEPI and the Bill & Melinda Gates Foundation has expanded their commitments of
improving access to vaccines in Africa on December 12, 2023.

https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

https://www.aspenpharma.com/
https://www.aspenpharma.com/media/press-releases

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 Hikma
Headquarters: London

2021 generic drug sales: $1.88 billion

2020 generic drug sales: $1.73 billion

Change: 9%

About Company and their Mission:

Hikma creates high-quality medicines and making them accessible to the people who need
them, Hikma are helping to shape a healthier world that enriches all our communities. They
are a trusted, reliable partner and dependable source of over 760+ high-quality generic,
specialty and branded pharmaceutical products that hospitals, physicians and pharmacists
need to treat their patients across North America, MENA and Europe. Hikma has 32
manufacturing plants and 8 R&D centres.

Management Team:
Said Darwazah Executive Chairman and Chief Executive Officer
Mazen Darwazh Executive Vice Chairman, President of MENA
Focus Therapeutic Area:
Hikma brings patients across North America, MENA and Europe a broad range of generic,
specialty and branded Injectables and Ophthalmic pharmaceutical products

Key Developments:
● Hikma launched Neostigmine Methylsulfate Injection prefilled syringe on June 15, 2023.
● Hikma launched Midazolam in 0.9% Sodium Chloride Injection in the US market on june 30,
2023.
● Hikma launched Dobutamine injection exceeding 150 injectable medicines in US market on
June 14, 2023.
● Hikma and Celltrion Healthcare has signed exclusive licensing agreement for ustekinumab &
YuflymaTM for the Middle East and North Africa region on January 03, 2023 & July 18, 2022
respectively.
● Hikma Ventures has lead Series A extension in NuvoAir to support its platform for patient-
centric care and clinical trials on January 19, 2022.

https://www.fiercepharma.com/pharma/top-10-generic-drugmakers-2021-revenue

https://www.hikma.com/

https://www.hikma.com/newsroom/

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6. CHALLENGES FOR INDIAN GENERIC COMPANIES - PATENT CLIFF 2022-30
6.1 Overview: Indian companies involved in developing generic versions of drugs going off-
patent face several challenges and risks. Despite these challenges and risks, Indian companies
have been successful in the generic drug industry by leveraging their manufacturing
capabilities, cost advantages, and regulatory expertise. It is important for Indian companies to
proactively address these challenges and perform risk assessment and build strong capabilities
to navigate the evolving landscape of generic drug development and manufacturing.
Developing and filing a 505(b)(2) ANDAs for the drugs nearing patent expiry can present
opportunities for Indian generic manufacturers to enter the much more bigger and lucrative
markets. By carefully assessing and managing the risks, Indian generic companies can navigate
the regulatory landscape and seize market opportunities out of the impending patent cliffs.
Some of the key challenges and risks include:
6.1.1 Complex Intellectual Property Landscape: Developing generic drugs involves navigating
complex intellectual property landscapes. Indian generic companies face legal
challenges from patent holders who may try to extend their exclusivity rights or sue the
Indian companies for patent infringement. Most of the originator companies choose to
initiate patent litigation against the Indian generic manufacturer. Resolving these
disputes can be time-consuming and costly. This results in delays in the approval and
launch of the generic version, as well as additional substantial legal costs for the Indian
generic companies. Further, the patent landscape is dynamic, and new patents or
changes to existing patents can impact the development of generic drugs. Indian
companies need to closely monitor patent expiration dates, patent challenges, and legal
developments to identify opportunities for generic drug development. The innovator
companies also try evergreening the patents by extending the exclusivity period of the
drugs by obtaining additional patents or regulatory exclusivities. This can delay the entry
of Indian generic competitors into the market.

6.1.2 Lack of R&D and Innovation: Developing generic drugs requires reverse engineering of
the drugs many time the incremental innovation in the pharmaceutical products. Indian
generics have the technical know-how for these processes however it requires
significant investment in research and development (R&D) and ensure bioequivalence
with the original branded drug. Indian companies face the challenge of balancing R&D
investments with the cost pressures of generic manufacturing.

6.1.3 Regulatory Compliance: Indian companies need to adhere to stringent regulations and
guidelines set by regulatory bodies such as the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMA). Further, regulatory policies and
requirements can change over time, potentially affecting the drug approval processes.
Changes in regulations, guidelines, or interpretation of regulatory standards can create
uncertainties and impact timelines for approval for Indian companies. Filing a 505(b)(2)
ANDA requires demonstrating that the proposed generic drug has the same active
ingredient as the reference listed drug (RLD) and relies, in part, on data from studies

84 | Page IMPENDING PATENT CLIFF 2022-2030

 conducted by others. There are challenges in obtaining the necessary data, navigating
the regulatory requirements, and addressing any deficiencies or inquiries from the
regulatory authorities. Non-compliance leads to delays in approvals or even rejection of
the generic versions.

6.1.4 Manufacturing and Quality Issues: Like any industry, the pharmaceutical sector is
subject to regulatory oversight and quality control measures to ensure the safety and
efficacy of drugs. Regulatory authorities such as the U.S. Food and Drug Administration
(FDA), the European Medicines Agency (EMA), and India's Central Drugs Standard
Control Organization (CDSCO) have systems in place to monitor and regulate
pharmaceutical manufacturing practices. Ensuring compliance with Good
Manufacturing Practices (GMP) and maintaining consistent quality during
manufacturing is crucial. Any deviations or issues in the manufacturing process can
result in delays in approval or even rejection of the ANDA. Failure to meet the prescribed
GMP standards can result in recalls, regulatory penalties, and damage to the company's
reputation Maintaining high-quality standards is crucial for generic drug manufacturers.
Occasional instances of quality and safety concerns have recently arisen due to factors
such as manufacturing issues, inadequate quality control, human errors, or non-
compliance with regulatory standards through-out the world and India is no exception
to it. While the majority of Indian pharmaceutical companies maintain high standards
of quality and safety, there have been some instances where quality and safety
compromises have been reported in Indian generic companies resulting in the import
ban on the products manufactured by such Indian companies. However, it is important
to note that such instances are generally exceptions rather than the norm, and the vast
majority of Indian generic pharmaceutical companies strive to maintain high-quality
standards and comply with safety, efficacy and regulatory requirements. When quality
or safety issues arise, regulatory authorities typically investigate the matter, take
appropriate actions, monitor the companies and may impose penalties or restrictions
to ensure compliance and protect public health. Additionally, many Indian
pharmaceutical companies have taken steps to address these issues, improve their
quality control systems, and strengthen their manufacturing practices Indian companies
need to move up the ladder and comply with Good Manufacturing Practices (GMP) as
per the standards of USFDA and EU rather than mere WHO standards. This will help
their products reach the more lucrative and profitable pharmaceutical markets rather
than supplying to third world countries of world. The increasing number of recognized
manufacturing sites by USFDA can reinforce India’s credibility as a reliable and quality-
focused pharmaceutical manufacturer.

6.1.5 Competition and Market Dynamics: The patent cliff is going to expand the market size
for global generic drugs as the expiration of patents allows multiple companies to enter
and compete. The $251 billion USD patent cliff presents a substantial opportunity for
generic companies to capture the market, share and generate revenue. However,
navigating the competitive landscape requires strategic planning, international

85 | Page IMPENDING PATENT CLIFF 2022-2030

 expansion, Life cycle management, efficient operations, regulatory compliance, and a
focus on differentiation to succeed in the impending evolving and dynamic market.
Market Barriers can pose as hurdles in accessing international markets as the Indian
companies have to navigate complex regulatory processes and obtain marketing
approvals from multiple authorities in different countries. Market-specific regional
factors such as local pricing policies, reimbursement systems, and market acceptance
of generics also pose challenges The acceptance of a generic drug by physicians,
patients, and healthcare providers can vary. The Indian companies sometimes face
hurdles in establishing relationships with distributors, pharmacy benefit managers
(PBMs), or negotiating favourable reimbursement agreements with payers. Further, the
pricing of generic drugs is subject to intense competition. When multiple generic
versions of a drug enter the market after patent expiry, it can lead to intense
competition and price erosion over the period. The pricing of the generic drug can be
significantly lower compared to the originator's product, impacting the profitability of
the generic manufacturer. Indian companies face challenges in maintaining profitability
due to price erosion caused by increased competition from other generic
manufacturers. Additionally, fluctuations in raw material costs and currency exchange
rates can affect the profitability of generic drug manufacturing.

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7 WAY FORWARD FOR INDIAN GENERIC COMPANIES TO MITIGATE BUSINESS RISKS

1. Investment in Incremental Innovation: Indian generic companies have a limited risk

appetite for the new drug development. However, the Indian companies are not
hesitant to invest in research and development (R&D) of generic incrementally
innovative pharmaceuticals formulations. This includes the development of novel drug
delivery systems, improved dosage forms, and enhanced therapeutic efficacy.
Innovation helps generic companies differentiate themselves from competitors and
gain a competitive edge in the market. In addition, R&D investment is necessary to
comply with stringent regulatory requirements. Generic pharmaceutical companies
must demonstrate bioequivalence to the reference product or the innovator drug
through comprehensive studies and clinical trials. Investing in R&D enables companies
to generate the necessary clinical data and evidence required for regulatory
submissions and approvals. By investing in R&D, generic companies can develop
patents, trademarks, and proprietary technologies. This helps in building a strong IP
portfolio, protecting their innovations, and ensuring market exclusivity for a certain
period, thus providing a competitive advantage. R&D investment allows generic
companies to expand their product portfolio by developing and launching a wider range
of generic drugs. This diversification enables them to target different therapeutic areas,
address unmet medical needs, and cater to a larger customer base. generic companies
in managing the lifecycle of their products effectively. By investing in R&D, they can
extend product life cycles through various strategies such as line extensions,
reformulations, and developing combination therapies. This allows them to maximize
product value and market presence even after the expiry of the reference product's
patent. A well-diversified portfolio enhances revenue opportunities and reduces
dependency on a few products.

2. Market Differentiation: R&D investment enables generic companies to develop niche

or specialty products that may have limited competition. These products may target
rare diseases, orphan indications, or specific patient populations. By focusing on
specialized therapeutic areas, generic companies can differentiate themselves,
command higher pricing, and establish a unique market position. Unique product
portfolio opens doors for Indian generic companies to collaborations and partnerships
with other global pharmaceutical companies, research institutions, and academic
organizations. Such partnerships can leverage shared expertise, resources, and
infrastructure to accelerate the development of new generic products, access external
knowledge, and gain a competitive advantage.

3. Cost Reduction and Efficiency: Indian companies need to invest into their process
improvements to ensure operational efficiencies and cost optimization. By investing in
research, generic companies can discover more efficient manufacturing techniques,
improve quality control processes, and reduce production costs. This can result in
competitive pricing, higher profit margins, and improved operational efficiency.

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 4. Product Diversification: Product diversification is crucial for Indian generic companies
to reduce risk, enhance competitiveness, and achieve sustainable growth in the ever-
changing pharmaceutical industry. By expanding their product offerings and targeting
diverse markets, generic companies can build resilience, adapt to market dynamics, and
capture a larger share of the global healthcare market Product diversification is the need
of hour for Indian generic companies for several reasons. The pharmaceutical industry
is highly competitive, and generic companies face numerous risks such as long and
costly patent litigations, regulatory hurdles, and intense competition. Diversification
helps mitigate these risks by spreading them across multiple products and therapeutic
areas. If one product faces challenge or fails to perform as expected, other products can
compensate for the loss, reducing the overall impact on the company's financial health.
By diversifying their product portfolio, Indian generic companies can target a broader
range of therapeutic areas, which allows them to access larger markets and reach a
wider customer base. This helps reduce reliance on a single product or therapeutic
category, making the company less vulnerable to fluctuations in demand or changes in
market dynamics. A well-diversified product portfolio provides more stable revenue
streams. Different products may have varying lifecycles, market dynamics, and
competitive landscapes. By having a mix of products at different stages of their lifecycle,
Indian generic companies can balance revenue fluctuations and maintain a consistent
revenue stream over time. Diversification enables generic companies to differentiate
themselves from competitors. By offering a wide range of products, they can cater to
diverse customer needs and preferences. This can create a competitive advantage by
attracting a larger customer base, better distributorship network, building brand
recognition, and establishing strong relationships with healthcare providers.

5. Partnerships and Collaborations: Indian Generic companies need to always look for
Partnerships and collaborations to take advantage of the potential opportunities
created due the patent expiration. In case of inadequate inhouse research and
development capabilities or limited products in R&D kitty, partnering with research
institutions, academic organizations, or other pharmaceutical companies provides
generic companies with access to additional R&D capabilities and expertise. This
enables them to accelerate the development of generic versions of drugs whose patents
are expiring. Collaborations can help expedite the research process, reduce
development costs, and enhance the likelihood of timely market entry.

6. Knowledge and Technology Transfer: Collaborating with partners who have expertise
in specific therapeutic areas or technologies allows generic companies to gain valuable
insights and knowledge. This knowledge transfer can aid in understanding the intricacies
of the branded drugs and their formulations, facilitating the development of effective
generic alternatives. Access to partner technologies can also improve manufacturing
processes and enhance the quality of generic products. Establishing local manufacturing
capabilities or entering into technology transfer agreements can enhance market

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 presence of Indian generic companies and overcome the country specific trade barriers.
Local production can lead to cost savings, improved supply chain efficiency, and
regulatory advantages, while technology transfer facilitates knowledge sharing and
capacity building, supporting local economic growth and market expansion. Regulatory
requirements for generic drug approvals vary across different regions, and partnering
with companies or organizations experienced in navigating regulatory landscapes can
help expedite the approval process. Collaborators can assist in compiling the necessary
documentation, conducting bioequivalence studies, and addressing regulatory queries,
ensuring a smoother path to market entry.

7. Market Access and Distribution: Partnering with established pharmaceutical

companies or distributors can help Indian generic companies gain access to established
distribution networks and market channels across the globe. Collaborations can provide
opportunities to leverage existing sales and marketing capabilities, enabling generic
products to reach a wider customer base more efficiently. Partnerships can also help
navigate complex market dynamics, negotiate pricing and reimbursement agreements,
and create market entry strategies. By joining forces with complementary partners,
generic companies can offer value-added services, differentiated product formulations,
or unique therapeutic combinations. Such collaborations enhance the competitive
advantage and increase the attractiveness of generic alternatives in the market.

8. Risk Sharing and Cost Optimization: Collaborations allow for risk sharing and cost
optimization. Developing generic alternatives to branded drugs requires significant
investments in R&D, clinical trials, and regulatory compliance. By partnering with other
companies or organizations, the financial burden and risks associated with these
activities can be shared. Collaboration can help reduce costs, increase efficiency, and
improve resource allocation, thereby maximizing the potential return on investment.

9. Business Development and Licensing Opportunities: Collaborations can provide Indian

generic companies with access to potential licensing and business development
opportunities. Partnering with innovative pharmaceutical and biopharmaceutical
companies or research institutions may open avenues for in-licensing or acquiring new
drug candidates or technologies. This enables generic companies to expand their
pipeline, explore new revenue streams, and drive future growth. Partnering with other
pharmaceutical companies can facilitate portfolio expansion and diversification. By
combining resources and capabilities, generic companies can expand their product
offerings and target a broader range of therapeutic areas. This enables them to capture
a larger market share, mitigate risks associated with a single product, reduce
dependence on a limited portfolio and establish a stronger presence in the market

10. Market Research: Conducting thorough market research is essential for Indian generic
companies to understand the demand, competition, pricing dynamics, and regulatory

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 landscape in different geographies. By identifying market opportunities, unmet needs,
and emerging trends, Indian generic companies can develop targeted strategies for
market entry and expansion. Customizing product offerings based on regional market
needs can enhance acceptance and adoption of Indian generic companies and their
products. Gradual expansion into new geographical regions is a common approach
whereby Indian companies can start by targeting regions with favourable regulatory
environments, growing healthcare infrastructure, and high demand and acceptance of
generic drugs. Once a strong foothold is established, further expansion into
neighbouring countries or other strategic markets can be pursued by such companies.
Investing in regulatory expertise and building a strong regulatory affairs team can
further facilitate market access and expansion of Indian generic companies. Indian
Generic pharmaceutical companies can collaborate with international pharmaceutical
companies for licensing, distribution, or manufacturing agreements to access new
markets. Developing an efficient and reliable supply chain is crucial for global expansion.
Once the Indian company develops any international collaboration, ensuring
uninterrupted supply of raw materials (API and excipients) & finished products, reducing
lead times, and managing logistics effectively are essential to meet customer demand
in different regions. Collaborating with reliable suppliers, optimizing inventory
management, and implementing robust distribution strategies are key elements of a
successful global supply chain. Partnering with established local companies in foreign
countries that have a strong presence and distribution networks in specific regions can
help Indian generic companies navigate regulatory complexities and cultural nuances,
enabling market entry and expansion. Acquiring or merging with local companies or
competitors in target markets can expedite market entry and expansion for Indian
companies. This strategy provides access to established infrastructure, distribution
networks, customer relationships, and regulatory knowledge.

11. Authorized Generics Model: In some cases, Indian generic companies may enter into
agreements with the original brand manufacturer to produce and market an
"authorized generic" version of the drug. These authorized generics are essentially
identical to the branded drug and are often priced competitively (substantially less than
the innovator but relatively higher than the generic products) to capture a significant
market share. This strategy leverages the brand recognition of the original drug while
offering a more affordable alternative. Pharma major Dr Reddy’s Laboratories Ltd has
expanded its collaboration with Amgen in India to market and distribute three of the
latter’s medicines in the domestic market. As part of the collaboration, Hyderabad-
based Dr Reddy’s commercialized Amgen’s XGEVA (denosumab), Vectibix
(panitumumab) and Prolia (denosumab) in the therapeutic areas of oncology and
osteoporosis.

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 8. WAY FORWARD FOR INDIAN GENERIC COMPANIES TO MITIGATE QUALITY RISKS

Quality assurance and safety are paramount during the development of generic versions of
patented drugs. When evaluating the quality and safety of pharmaceutical products, it is
essential for Indian generic companies to consider the overall regulatory framework,
compliance track record, and reputation of the specific company. Regulatory authorities, such
as the FDA, EMA, and CDSCO, play a critical role in ensuring adherence to standards and
addressing any reported issues. By adhering to stringent quality assurance measures,
conducting thorough testing and evaluations, and complying with regulatory requirements,
generic drug manufacturers can mitigate safety concerns and ensure that their products are
safe, effective, and of high quality for patients. Generic pharmaceutical companies exploring
the markets of off-patent drugs need to implement robust quality assurance and compliance
measures to ensure the safety, efficacy, and quality of their products. By implementing the
quality assurance and compliance measures, generic pharmaceutical companies can ensure the
consistent quality of their products, meet regulatory requirements, and build trust among
healthcare professionals and patients. A strong focus on quality, compliance, and patient safety
is paramount to the success and reputation of Indian generic companies in the global
marketplace. Below are some key measures that should be taken by Indian Generic companies:

1. Establish a Quality Management System (QMS): Establishing a comprehensive QMS is

vital for Indian generic companies with global aspirations. A well-designed QMS
encompasses procedures, policies, and processes that ensure consistent quality
throughout the entire product lifecycle, from product development to manufacturing,
distribution, and post-marketing surveillance. This includes documentation control,
change management, internal audits, and continuous improvement initiatives.
Implementing a culture of continuous improvement is crucial for generic companies to
stay competitive and maintain high-quality standards. This involves monitoring key
performance indicators, conducting regular quality reviews, and implementing
corrective and preventive actions to address any deviations or non-conformities. The
Indian generic companies with global aspirations should establish robust testing
protocols and employ analytical techniques, such as chromatography, spectroscopy,
and dissolution testing, to assess the product's compliance with established
specifications. Learning from quality incidents, customer feedback, and emerging
industry trends helps drive continuous improvement initiatives.

2. Active Pharmaceutical Ingredient (API) and Key Starting Material (KSM) Sourcing:
Generic manufacturers need to ensure the quality and safety of the API and KSM used
in their products. Most of this raw material is imported by Indian companies from
countries like China. Indian Generic companies should have a robust supplier
qualification process in place to ensure the quality and reliability of raw materials, APIs,
and other components sourced from external suppliers. Conducting regular audits of
suppliers, assessing their quality systems, and verifying compliance with quality
standards are important steps to mitigate supply chain risks. The Indian companies need

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 to perform proper due diligence before the selection of API suppliers and should not be
dependent only on the documents like Certificate of Analysis (CoA) issued by the
suppliers of raw materials. The Indian generic companies should have systems in place
for the testing of incoming raw materials ensuring compliance with regulatory
requirements for purity, stability, and impurity levels. If the companies, do not have the
such inhouse testing capabilities for checking the quality of incoming APIs and KSMs,
they can outsource the testing activities to NABL accredited laboratories after proper
due diligence of such labs. Ensuring the quality of imported APIs and KSMs is the most
important step Indian companies need to take with the immediate effect.

3. Manufacturing Standards: Generic drug manufacturers need to adhere to Good

Manufacturing Practices (GMP) to maintain quality standards throughout the
manufacturing process. GMP regulations cover various aspects, including facility design,
equipment qualification, raw material sourcing, process controls, packaging, labelling,
and quality control testing. However, surprisingly the GMP standards have a unsaid
grading system whereby GMP standards of USFDA & European countries are rated
above the WHO GMP and the GMP requirements of semi-regulated markets. Indian
generic companies should keep a long-term perspective and invest in facilities,
equipment, and systems as per the requirements of regulators like USFDA and EMEA.
Compliance with GMP as per US & EU standards ensures consistent quality and safety
of the generic drugs. Rigorous quality control testing should be conducted throughout
the manufacturing process to ensure that the generic drug meets the required
specifications for identity, strength, purity, and quality. These tests include assays,
dissolution testing, impurity analysis, stability testing, and other quality parameters to
confirm product quality and safety. In addition, the generic companies should establish
comprehensive batch release procedures to ensure that each batch of the product
meets the required specifications before being released for distribution. Batch release
includes a thorough review of manufacturing records, quality control test results, and
compliance with applicable regulatory requirements. The documentation associated
with batch release should be maintained as part of the company's quality records.
4. Conducting Bioequivalence Studies of Generic Drugs in reputed CROs: For the generic
pharmaceutical products, the pharmaceutical companies do not need to go through
entire clinical development cycle of Phase I to Phase IV. It is because the innovator drugs
are in the market for a long period and have been already been proven to be safe and
efficacious in a particular disease indication. In such case, generic versions of drugs must
demonstrate bioequivalence to the Reference Listed Drug (RLD) in terms of
pharmaceutical equivalence and bioavailability. Indian generic companies need to
conduct Robust comparative studies, including pharmacokinetic and pharmacodynamic
assessments, to establish the similarity of the generic drug to the RLD. Ensuring
bioequivalence is crucial for the safety and efficacy of the generic version and also a part
of the regulatory dossiers submitted to various regulatory agencies to obtain marketing
authorisation in respective countries. Most of the pharmaceutical companies outsource
the Bioequivalence studies to the specialized BA/BE CROs in India. There have been

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 some instances related to misconduct and data integrity violations by their hired CROs
particularly working in the domain clinical bioequivalence and bioavailability studies.
The Indian generic companies need to be very careful and conduct proper due diligence
while selecting the CROs for conducting the bioequivalence studies because the data
integrity issues can lead to jeopardizing the entire ANDA submission of the generic
pharmaceutical companies.
5. Stability Testing: Pharmaceutical companies need to conduct stability testing as per the
different zone requirements to assess the shelf life and storage conditions of the generic
drugs. Conducting product stability studies is crucial to determine the shelf life and
storage conditions of off-patent drugs. These studies assess the chemical, physical, and
microbiological stability of the product over time and under different environmental
conditions. It helps to determine the expiration date and provide for the shipping and
storage recommendations to ensure that the drug maintains its quality, safety, and
efficacy during the transient and throughout its intended shelf life.
6. Pharmacovigilance and Adverse Event Reporting: Continuous monitoring of the
generic drug's safety and effectiveness after it enters the market is essential. Post-
marketing surveillance programs help detect and assess any potential safety issues that
may not have been apparent during clinical trials. Timely reporting and response to
safety concerns are crucial to ensure patient well-being. Implementing a robust
pharmacovigilance system is crucial for monitoring and reporting adverse events
associated with off-patent drugs. Indian Generic companies with global aspirations
should establish processes to capture, evaluate, and report any safety concerns
promptly. Compliance with pharmacovigilance regulations ensures the ongoing
7. Labelling and Patient Information: Generic companies need to ensure compliance with
applicable regulatory requirements of labelling in each market they operate in. This
includes obtaining necessary regulatory approvals, adhering to labelling and packaging
regulations, and complying with pharmacopeial standards. Keeping abreast of
regulatory updates and changes is essential to maintain compliance and meet evolving
regulatory expectations. Accurate and comprehensive labelling and patient information
are essential for ensuring the safe use of generic drugs. Clear instructions, warnings, and
precautions must be provided to healthcare professionals and patients to minimize any
potential risks and promote safe and effective use of the medication.

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 9. PRICING STRATEGIES FOR INDIAN GENERIC COMPANIES

Patent expiration a natural milestone in a product’s lifecycle and could mean the end of a
product’s value however the innovator companies similar to market launch strategically plan it
to ensure optimum returns. Prior to executing a successful generic product launch strategy, it
is critical to understand existing product dynamics across stakeholders, namely physician,
pharmacy and patient. Indian Generic pharmaceutical companies have several pricing
strategies that they can consider after the patent of a drug expires. Implementing competitive
pricing strategies, especially in price-sensitive markets, can facilitate market penetration and
expansion. There is no standard pricing model which can be opted by all Indian companies for
all types of drugs. Indian generic pharmaceutical companies can explore differential pricing
models based on regional economic factors and healthcare systems to ensure affordability and
improve accessibility.

The Indian companies need to monitor the market dynamics, generic competitor's pricing
strategy, innovator's pricing actions and customer feedback to assess the effectiveness of their
pricing strategies and make the necessary adjustments as needed. In addition, the factors such
as production costs, competition, market demand, regulatory requirements, and
reimbursement scenario need to be factored in while determining the pricing strategies. Given
the high variation in affordability and lower prices of branded generics, patent cliff is going to

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create economic incentives for physicians and patients (and payors in limited cases) to shift
volume from innovator brands to generics. The resulting rapid decline in a brand’s volume and
market share becomes the primary concern of brands facing loss of exclusivity (LoEs). While
some degree of branded volume erosion due to generics seems inevitable, the extent of a
brand’s decline can be mitigated even by the innovator companies through strategic initiatives.
Key factors which influence the prices of generic/biosimilar drugs are tabled below:

Key factors influencing the prices of biosimilars/ Generics

S. No. Factor(s) Impact on price

1. Market share The price varies as per the market share of generic medicines.
Competition from generic medicines leads to price reductions.
Generic market share is directly proportional to a decrease in
prices.
2. Market The chances of generic suppliers responding to factors influencing
competition and demand size and market competition are high. Originators set
demand prices strategically to reduce compulsory licensing and generic
competition threats.
3. Entry of new The introduction of the new biosimilar/generic drug generally
biosimilar/Generics result in substantial cost savings for healthcare.
4. Efficacy and safety A biosimilar/generic's price is only one aspect of its full value. In
addition to taking into account development and manufacturing
expenses, the outcomes of efficacy and safety in comparison to the
reference biologic/innovator’s medicine are also taken into
account.
5. Per capita income Per capita GDP is important factor while pricing the drugs. For
example, the price of insulin drugs originating from OECD countries
is higher than that imported from developing countries.
6. List prices, net The price drop is observed for originators after the entry of
prices, discounts biosimilars/generics or other substitutes in the market. The entry
of biosimilars/generics stops the increase in list prices but net
prices commence to decrease due to discounts offered by
companies.

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 7. Trust and To increase the market acceptance of biosimilars/generics,
confidence of the clinicians' and users' trust and confidence are essential. This may
physician increase the demand and impact the price.
8. Originator vs Switching originator drugs to generics can result in savings of upto
generics 65% for patients.

9. Selection strategy The price of the originator varies with the selection strategy
between branded and generic drugs in out-of-hospital pharmacies,
but not in in-house pharmacies of medical facilities.
10. Differential pricing Differential pricing policies are feasible mostly for ‘global’ diseases,
policies where drugs through worldwide sales recoup their R&D costs. The
differential prices vary with the pharmaceutical industry and do
not encourage sustainability or autonomy in developing countries.
11. Pricing policies Despite many efforts toward the implementation of policies like
internal reference, tendering and generic substitution to increase
biosimilar/generics adoption, a large difference remains in the
price and uptake of medicines between countries.
12. Price cap A continuous decline in the ceiling prices is associated with a high
Regulations incidence of exit of innovator firms from markets.

The ultimate objective of any generic company is to offer affordable alternatives to the branded
drugs while quickly maximizing market share and profitability. Engaging in discussions with
governments, payers, and healthcare providers to promote the benefits of generic medicines
and advocate for favourable reimbursement policies can also support market access. Below are
some of the pricing strategies that can be opted by Indian Generic companies:

1. Competitive Pricing Strategy: Generic companies often adopt a competitive pricing

strategy to gain a significant market share. They typically set their prices lower than the
branded drug but higher than other generic competitors. This strategy aims to attract
customers who prioritize cost savings while still maintaining a reasonable profit margin.
For example, the price of the generic version of Lipitor, a cholesterol-lowering drug, is
70% to 90% lower than the branded version's price. Generic Pharmaceutical companies
use reference pricing to compete with other generic drug manufacturers in the market .

2. Cost-Plus Pricing Strategy: Cost-plus pricing involves determining the manufacturing

and distribution costs associated with the generic drug and adding a predetermined

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 profit margin to arrive at the selling price. This strategy ensures that the price reflects
the actual costs incurred by the generic company while allowing them to generate a
reasonable profit. The development of a new drug can cost between $2.6 billion to $3
billion for innovator companies. Innovator Pharmaceutical companies add a markup to
the production cost, which can range from 50% to 500%, to set the drug's price. Generic
companies do not have to spend on the fundamental research and development of
these drugs and therefore once they have the marketing approval for their generic
version, they can play on the markup depending on the region, patient base and the
reimbursement policies.

3. Market Penetration Pricing Strategy: Market penetration pricing involves setting the
initial price of the generic drug lower than the competing branded drug or other generic
alternatives. This strategy aims to quickly capture a significant market share by enticing
customers with a lower-priced option. Once the market share is established, the
company may consider adjusting the price upwards to align with competitors

4. Price Skimming Strategy: After the loss of exclusivity, the Indian generic Companies
specially the ones which are able to get exclusivity for 3 months can set the initial price
of the generic drug relatively high to capitalize on customers who are willing to pay a
premium for early access to the generic version. They can set the price slightly lower
than the innovator company so as to provide a small cost benefit to the customers who
are early adopters. This strategy is often employed when there is limited initial
competition in the market. Over time, as more competitors enter the market, the price
is gradually reduced to attract price-sensitive customers. In Indian scenario, this has
been a quite prevalent trend followed by the generic companies.

5. Value-Based Pricing Strategy: Value-based pricing focuses on pricing the generic drug
based on the perceived value it provides to patients, healthcare providers, or payers.
The price is determined by considering factors such as therapeutic benefits, cost-
effectiveness, convenience, and patient outcomes compared to the branded drug. This
strategy requires a deep understanding of the market and the ability to demonstrate
the value proposition of the generic product. For example, a drug that can cure a life-
threatening disease has a higher perceived value than a drug that treats a common
ailment. Pharmaceutical companies use value-based pricing to set the price of high-
value drugs, such as cancer medications.

6. Differential Pricing Strategy: Differential pricing strategy, also interchangeably known

as ‘tiered pricing’ or ‘equity pricing’, refer to the adjustment of drugs' costs according
to the consumer's ability to purchase the goods. This strategy could take an important
part in improving access to essential medicines by regulating prices so that the
medicines are more affordable for the people in developing countries. Once the Indian
generic companies get the Marketing authorisation in regulated markets like US and

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 Europe, the companies can go ahead with setting different prices for different market
segments or geographic regions based on factors such as purchasing power, market
demand, and competitive dynamics. Because larger doses are sold in developing
countries, differential pricing may be beneficial for all stakeholders. Differential pricing
can also be feasible as there are substantial fixed costs, and variable or marginal costs
(the costs of production and distribution) are relatively low as the pharmaceutical
industry may have invested heavily on this in the high-income economies. Hence,
differential pricing allows low-income markets to pay only for marginal costs and high-
income countries to pay more than marginal costs to cover the costs of research and
development. Differential pricing can be in the interests of all parties as far as the
markets could be effectively segregated. The segmentation would prevent diversion of
low-priced products into high-income markets and a readiness on the part of consumers
in high-income economies to accept the higher prices. Indian Generic companies may
offer lower prices in less affluent regions or negotiate discounted prices with bulk
purchasers, such as government healthcare programs or hospital chains, while
maintaining relatively higher prices in more affluent markets.

However sometimes, the highly skewed income distributions within lower-middle and
middle-income countries seriously hinder the ability of the generic companies to do
differential pricing. Inter-country differential pricing cannot guarantee affordable prices
to the poorest population segments in lower-middle and middle-income countries, as
that would imply pharmaceutical companies forego the profits from the higher income
segments in these countries. At the same time, the poorest segments and their
advocacy groups feel ―en tled to the prices provided to low income and least
developed countries. Differential pricing is however not based on differences in the
prices offered on contract but on a complex system of rebates and discounts. The price
of drugs paid by the consumer is determined by a system of negotiated volume-rate
contracts between manufacturers, pharmacy benefit managers (PBMs), wholesale
distributors, pharmacies, and health insurance companies. The price charged by each
entity in the chain is largely driven by the ability of contracting entities to sell specific
volumes of certain drugs or achieve a certain share of a specified market. It is also
affected partially by the value each entity brings to the subsequent actors in the supply
chain.

Differential pricing solutions are generally unworkable unless the different categories
of buyers can be prevented from trading with one another. Covid Vaccines present good
examples of intra-country differential pricing. For example, the Covid -19 vaccine was
offered Serum Institute at two different price points within India. It was sold to the
private sector market around INR 700, and to the government and NGOs around INR
200/dose. Other examples of differential pricing that has been successfully
implemented in pharmaceutical industry include oral contraceptives; and medicines for
human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS),
tuberculosis (TB) and malaria. With differential pricing, some of these drugs, namely

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 vaccines and oral contraceptives, cost as much as 200 times less for low-income
markets. As a result, millions of people obtained access to these pharmaceutical
products. However, some of the limitations of differential prices include the availability
at minimum cost on a long-term basis, transparency in prices and setting minimum
conditions to verify the eligibility of developing countries.

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10. REFERENCES

Below mentioned product specific literature has been referred to

https://www.rxabbvie.com/pdf/humira.pdf
https://www.keytruda.com/
https://www.drugs.com/keytruda.html

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.revlimid.com/
https://medlineplus.gov/druginfo/meds/a608001.html

https://www.eliquis.bmscustomerconnect.com/
https://en.wikipedia.org/wiki/Apixaban
https://www.medicalnewstoday.com/articles/eylea
https://eylea.us/s
https://www.stelarainfo.com/
https://www.drugs.com/stelara.html
https://www.rxlist.com/opdivo-drug.htm
https://www.opdivo.com/
https://us.tivicay.com/
https://www.webmd.com/drugs/2/drug-164908/tivicay-oral/details

https://www.ibrance.com/about-ibrance
https://www.januvia.com/
https://www.trulicity.com/
https://www.xgeva.com/
https://www.prolia.com/

https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf
https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&docume
ntnumber=1
https://www.novo-pi.com/victoza.pdf
https://www.gene.com/download/pdf/avastin_prescribing.pdf
https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-
com/Enbrel/enbrel_pi_CURNT.pdf
https://app.purduepharma.com/xmlpublishing/pi.aspx?id=o
https://products.sanofi.us/Lantus/Lantus.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf

100 | Page IMPENDING PATENT CLIFF 2022-2030

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf
https://www.lyrica.com/en
https://www.rxlist.com/lyrica-drug.htm

https://www.janssenlabels.com/package-insert/product-monograph/prescribing-
information/XARELTO-pi.pdf

India's Cadila launches first cheaper copy of world's top-selling drug | Reuters

Natco Pharma announces launch of first generic of top selling cancer drug Revlimid - The Economic
Times (indiatimes.com)
Top diabetic drug goes off patent, prices to fall by 3rd - Times of India (indiatimes.com)
Dr Reddy's laboratories: Dr Reddy's launches Roche's Avastin biosimilar in India - The Economic Times
(indiatimes.com)
India: insulin and biosimilars market value 2020 | Statista
https://www.indianpharmapost.com/drug-approval/alembic pharmaceuticals-receives-pas-approval-
from-usfda-for-pregabalin-capsules-13493
https://www.statista.com/statistics/1202009/india-market-value-of-leading-molecules-in-cardiac-
segment/#:~:text=Rosuvastatin%20was%20the%20leading%20molecule,top%20ten%20molecules%20
that%20year
https://twitter.com/CapitalMarket17/status/1730132935817175060

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 ANNEXURE - A
S.No Drug Salt Indication Molecular Size Patent Number Year of Patent Expiry Parent Company Potential Indian Generic Manufacturers Dosage Form Pharmacological Classification
1 Tafinlar Dabrafenib Mesylate Braf (V600)-Mutated Metastatic Melanoma Small US7994185 January 20, 2030 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Reversible ATP-Competitive Kinase Inhibitor
US8415345 January 20, 2030 Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
US8703781 October 15, 2030
2 Cosentyx Secukinumab Moderate To Severe Plaque Psoriasis In Adult Large US7807155 February 09, 2030 Novartis Intas, Cipla, Reliance , Lupin Subcutaneous Monoclonal Antibodies
Patients Who Are Candidates For Systemic Pharmaceuticals Corp Injection
Therapy Or Phototherapy.
Adults With Active Psoriatic Arthritis (Psa).
Adults With Active Ankylosing Spondylitis (AS)
3 Copiktra Duvelisib Chronic Lymphocytic Leukemia, Small Small US8193182 February 13, 2030 Secura Bio Inc Natco, Dr Reddy's, sun pharma, Cipla, Panacea Oral Kinase Inhibitor
Lymphocytic Lymphoma, And Follicular USRE46621 May 17, 2032 Biotec, United Bioted, Intas Pharma, SR pharma,
Lymphoma Zydus Cadila
4 Seglentis Celecoxib/Tramadol Management And Treatment Of Pain Small US10238668 April 19, 2030 Kowa Pharmaceutical Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Opioid Analgesics
Hydrochloride US9012440 April 19, 2030 America Inc Alembic
US8598152 April 19, 2030
US10245276 April 19, 2030
5 Veltassa Patiromer High Blood Potassium Small US8337824 May 29, 2030 Vifor Pharma Inc Lupin, Cipla, Unimark Oral Potassium Removing Agent
6 Olumiant Baricitinib Rheumatoid Arthritis And Covid-19 Small US8158616 June 8, 2030 Eli Lily and Co Intas, Cipla, Reliance, Lupin Oral Janus Kinase (Jak) Inhibitor
7 Voxzogo Vosoritide Achondroplasia Large US8198242 June 11, 2030 Biomarin Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous C Type Natriuretic Peptide (CNP) Analog
Inc Macleods, Mankind, Cipla, Torrent
8 Apadaz Acetaminophen/Benzhydr Moderate To Severe Pain Small US9132125 July 1, 2030 Kvk Tech Inc Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Subcutaneous Analgesics (Pain Relievers) And Antipyretics (Fever
ocodone Hydrochloride US9549923 July 1, 2030 Alembic Reducers)/Narcotic Analgesics
US8748413 July 10, 2030
US8461137 February 22, 2031
9 Segluromet Ertugliflozin-Metformin Type 2 Diabetes Small US8080580 July 13, 2030 Merch Sharp and Dohme Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Subcutaneous Sodium-Dependent Glucose Cotransporters
Hydrochloride Corp Medipol, Zydus, Aristo and Quest Pharma Inhibitor/Biguanides
10 Qinlock Ripretinib Advanced Gastrointestinal Stromal Tumor Small US8188113 July 27, 2030 Deciphera BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8461179 June 7, 2032 Pharmaceutical Llc Zydus, Glenmark, MSN, Dr Reddy, Natco
11 Parsabiv Etelcalcetide Secondary Hyperparathyroidism Small US9701712 July 29, 2030 kai pharmaceutical Inc Abbott, Macleods, Intas, Lupin Intravenous An Oligopeptide
US9278995 July 29, 2030
US8377880 July 29, 2030
US8999932 February 7, 2031
12 Alunbrig Brigatinib Non Small Cell Lung Cancer Small US9012462 July 31, 2030 Takeda Pharmaceutical BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Tyrosine Kinase Inhibitor
US10385078 November 10, 2035 USA Inc Zydus, Glenmark, MSN, Dr Reddy, Natco
13 Brexafemme Ibrexafungerp Citrate Vulvovaginal Candidiasis Small US8188085 August 28, 2030 Scynexis Inc Abbott, Cadila Oral Triterpenoid Antifungal Agent
US10174074 January 19, 2035
US10927142 January 19, 2035
14 Nubeqa Darolutamide Non-Metastatic Castration-Resistant Prostate Small US8975254 October 27, 2030 Bayer Healthcare BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Androgen Receptor Inhibitors
Cancer US9657003 October 27, 2030 Pharmaceuticals Inc Zydus, Glenmark, MSN, Dr Reddy, Natco
US11046713 October 27, 2030
US10711013 October 27, 2030
US10383853 January 28, 2036
US10010530 January 28, 2036
US11168058 February 27, 2038
15 Harvoni/Hepcinat-LP Ledipasvir/Sofosbuvir Hepatitis C Small US8822430 November 12, 2030 Gilead Sciences Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Direct-Acting Antiviral Agents
US8088368 November 12, 2030 Macleods, Mankind, Cipla, Torrent
US10039779 July 30, 2034
16 Rinvoq Upadacitinib Rheumatoid Arthritis And Psoriatic Arthritis Small USRE47221 December 1, 2030 Abbvie Inc Intas, Cipla, Reliance , Lupin Oral Janus Kinases Inhibitor
US8962629 January 15, 2031
US10981923 October 17, 2036
US9951080 October 17, 2036
US11186584 October 17, 2036
17 Nerlynx Neratinib Breast Cancer Small US7399865 December 29, 2030 Puma Biotechnology BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
18 Lamictal Odt Lamotrigine Epilepsy Small US7919115 January 4, 2029 GlaxoSmithKline Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Triazine
Macleods, Mankind, Cipla, Torrent
19 Wakix Pitolisant Hydrochloride Excessive Daytime Sleepiness Small US8207197 February 25, 2029 Harmony Biosciences LIc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral H3 Autoreceptors Blocker
Macleods, Mankind, Cipla, Torrent
20 Caplyta Lumateperone Tosylate Schizophrenia And Bipolar Disorder Small US9586960 March 12, 2029 Intra-cellular Therapies Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotics
USRE48825 March 12, 2029 Inc India, Reliance Formulation
US8648077 December 1, 2029
21 Desyrel Trazodone Hydrochloride Major Depressive Disorder, Anxiety Disorders, Small US8133893 March 13, 2029 Pragma Pharmaceutical Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Serotonin-Antagonist-And-Reuptake-Inhibitor
And Difficulties With Sleep India, Reliance Formulation
22 Neuraceq Florbetaben F-18 Alzheimer's Disease Small US7807135 March 18, 2029 Life Molecular Imaging Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Stilbenoids
Ltd Macleods, Mankind, Cipla, Torrent
23 Monoferric Ferric Derisomaltose Iron Deficiency Anemia Small US10414831 March 25, 2029 Pharmacosmos As Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Iron Carbohydrate Oligosaccharide
US8815301 August 14, 2029 Macleods, Mankind, Cipla, Torrent
24 Gemtesa Vibegron Overactive Bladder Small US8653260 April 2, 2029 Urovant Sciences Gmbh Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Beta-3 Adrenergic Agonists
US8247415 December 1, 2030 Macleods, Mankind, Cipla, Torrent
25 Kerendia Finerenone Kidney Function Small US8436180 April 12, 2029 Bayer Healthcare Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Mineralocorticoid Receptor (MR) Antagonists
Pharmaceuticals Inc Macleods, Mankind, Cipla, Torrent
26 Triferic Ferric Pyrophosphate Iron Deficiency Anemia Large US7816404 April 17, 2029 Rockwell Medical Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Phosphate Binders And Iron Replacement Products
Citrate Macleods, Mankind, Cipla, Torrent
27 Cipro Ciprofloxacine Bacterial Infection Small US9603796 April 21, 2029 Alk-Abello Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous, Fluoroquinolones
Macleods, Mankind, Cipla, Torrent Topical
28 Veklury Remdesivir Antiviral Small USRE46762 April 22, 2029 Gilead Sciences Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Nucleoside Analog
US8318682 April 22, 2029 Macleods, Mankind, Cipla, Torrent
US8008264 September 6, 2029
US10065958 September 16, 2031
US9724360 October 29, 2035
US9949994 October 29, 2035
29 Zejula Niraparib Tosylate Anti-Cancer Small US8436185 April 24, 2029 GlaxoSmithKline BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Active Poly (ADP-Ribose) Polymerase (PARP) Inhibitor
US8071623 March 27, 2031 Zydus, Glenmark, MSN, Dr Reddy, Natco
30 Zeposia Ozanimod Hydrochloride Multiple Sclerosis And Ulcerative Colitis Small US8481573 May 14, 2029 Celgene International Li Sun Pharma, Alkem, Micro Labs, Abbott, Intas, Oral Sphingosine L-Phosphate Receptor Modulators
US8796318 May 14, 2029 Sarl Lupin, Torrent, IPCA
31 Tauvid Flortaucipir (18F) Radioactive Diagnostic Agent Small US8932557 May 19, 2029 Avid Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Small Lipophilic Tracer
Radiopharmaceuticals Macleods, Mankind, Cipla, Torrent
Inc
32 Opana Er Oxymorphone Severe Pain Small US7851482 July 10, 2029 Endo Pharmaceuticals Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Opioid Agonist
Hydrochloride US8871779 November 22, 2029 Inc Alembic
33 Braftovi Encorafenib Melanoma Small US8946250 July 23, 2029 Array Biopharma Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitors.
US8541575 February 26, 2030 Macleods, Mankind, Cipla, Torrent
US9593099 August 27, 2030
US8501758 March 4, 2031
34 Odomzo Sonidegib Phosphate Cancer Small US8178563 July 24, 2029 Sun Pharmaceutical BDR pharmaceuticals, Alkem, Hetero, Zydus, Oral A Hedgehog Signaling Pathway Inhibitor
US8063043 September 15, 2029 Industries Ltd Glenmark, MSN, Dr Reddy, Natco
35 Zepatier Elbasvir/Grazoprevir Hepatitis C Small US7973040 July 24, 2029 Merch Sharp and Dohme Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral HCV NS5A Inhibitors/Protease Inhibitors
US8871759 May 4, 2031 Corp Macleods, Mankind, Cipla, Torrent
36 Talzenna Talazoparib Tosylate Breast Cancer Small US8420650 July 27, 2029 Pfizer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Poly (ADP-Ribose) Polymerase (PARP) Inhibitors
US8012976 October 19, 2029 Zydus, Glenmark, MSN, Dr Reddy, Natco
US10189837 October 20, 2031
US8735392 October 20, 2031
37 Evotaz Atazanavir HIV/AIDS Small US8148374 September 3, 2029 Bristol-Myers Squibb Co Cipla, Emcure Pharma, Sun Pharma Oral Protease Inhibitor / Pharmacokinetic Boosters
Sulfate/Cobicistat
38 Piqray Alpelisib Breast Cancer Small US8476268 September 10, 2029 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8227462 September 28, 2030 Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
39 Tykerb Lapatinib Ditosylate Breast Cancer Small US8821927 September 18, 2029 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
40 Treanda Bendamustine Chronic Lymphocytic Leukemia, Multiple Small US8445524 September 26, 2029 Cephalon Inc Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Intravenous Alkylating Agents
Hydrochloride Myeloma, And Non-Hodgkin’s Lymphoma Biotec, United Biotech, Intas Pharma, SR Pharma,
Zydus Cadila
41 Ingrezza Valbenazine Tardive Dyskinesia Small US8039627 October 6, 2029 Neurocrine Bioscience Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Intravenous Vesicular Monoamine Transporter 2 Inhibitors
US10065952 October 28, 2036 Inc Formulation
US10844058 October 28, 2036
US10851103 October 28, 2036
US10851104 October 28, 2036
US10906902 December 22, 2036
US10919892 December 22, 2036
US10906903 December 22, 2036
42 Vitrakvi Larotrectinib Sulfate Cancer Small US9127013 October 21, 2029 Bayer Healthcare BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8513263 December 23, 2029 Pharmaceuticals Inc Zydus, Glenmark, MSN, Dr Reddy, Natco
US10172861 November 16, 2035
US10799505 August 15, 2036
43 Rezurock Belumosudil Mesylate Chronic Graft Versus Host Disease Small US8357693 October 30, 2029 Kadmon Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Serine/Threonine Kinase Inhibitors
Pharmaceuticals Macleods, Mankind, Cipla, Torrent
44 Cotellic Cobimetinib Fumarate Cancer Small US7803839 November 10, 2029 Genentech Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US10478400 June 29, 2036 Zydus, Glenmark, MSN, Dr Reddy, Natco
US10590102 June 30, 2036
45 Recarbrio Imipenem/Cilastatin Urinary Tract And Complicated Intra-Abdominal Small US8487093 November 19, 2029 Merch Sharp and Dohme Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Carbapenem Antibiotics/ Dehydropeptidase Inhibitors/ Beta
Sodium/Relebactam Infections Corp Macleods, Mankind, Cipla, Torrent Lactamase Inhibitor
46 Belsomra Suvorexant Insomnia Small US7951797 November 20, 2029 Merch Sharp and Dohme Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Orexin Receptor Antagonists
Corp Macleods, Mankind, Cipla, Torrent
47 Verzenio Abemaciclib Breast Cancer Small US7855211 December 15, 2029 Eli Lily and Co BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
48 Tavneos Avacopan Anti-Neutrophil Cytoplasmic Auto Small US8906938 December 21, 2029 Chemocentryx Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Complement Inhibitors
Antibody-Associated Vasculitis US8445515 February 3, 2031 Macleods, Mankind, Cipla, Torrent
49 Ibsrela Tenapanor Hydrochloride Irritable Bowel Syndrome Small US8541448 December 30, 2029 Aedelyx Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Sodium/Hydrogen Exchanger Isoform 3 Transporter Inhibitor
US8969377 December 30, 2029 Macleods, Mankind, Cipla, Torrent
50 Eucrisa Crisaborole Atopic Dermatitis Small US8039451 December 29, 2029 Anacor Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Phosphodiesterase Inhibitors
Inc Macleods, Mankind, Cipla, Torrent
51 Mutamycin Mitomycin Upper Gastro-Intestinal Cancers, Anal Cancers, Small US9539241 January 2, 2028 Biochem Pharmaceutical BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Powder Antineoplastic Antibiotic
And Breast Cancers Industries Zydus, Glenmark, MSN, Dr Reddy, Natco For Injection
52 Farydak Panobinostat Lactate Various Cancer Small US7989494 January 17, 2028 Secura Bio Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Latency-Reversing Agents
Zydus, Glenmark, MSN, Dr Reddy, Natco
53 Sivextro Tedizolid Phosphate Complicated Skin And Skin-Structure Infections Small US8420676 February 23, 2028 Cubist Pharmaceuticals Cipla, Mylan, Zydus Cadila, Alkem, United Biotech Oral, Intravenous Oxazolidinone-Class Antibiotic
(CSSSIS) US7816379 June 20, 2028
US9624250 February 3, 2030
US9624250 February 3, 2030
US8426389 December 31, 2030
54 Xenleta Lefamulin Pneumonia Small US8153689 March 19, 2028 Nabriva Therpeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Pleuromutilin Antibiotics
US8071643 January 16, 2029 Macleods, Mankind, Cipla, Torrent
US9120727 May 23, 2031
55 Vosevi Sofosbuvir/Velpatasvir/ Hepatitis C Small US7129232 May 15, 2028 Gilead Sciences Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Nucleotide Polymerase Inhibitors/ HCV NS5A Replication
Voxilaprevir US8685957 September 27, 2032 Zydus, Glenmark, MSN, Dr Reddy, Natco Complex Inhibitors / HCV NS3/4A Protease Inhibitor, And
US8476425 September 27, 2032 P-Glycoprotein Inhibitor, And Breast Cancer Resistance
US8906898 May 28, 2034 Protein Inhibitor, And Organic Anion Transporting
Polypeptide 1b1 Inhibitor And Organic Anion Transporting
Polypeptide 1b3 Inhibitor
56 Zerbaxa Ceftolozane/Tazobactam Urinary Tract Infection Small US8242294 May 16, 2028 Merck & Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Cephalosporin Antibiotic / Beta-Lactamase Inhibitor
Macleods, Mankind, Cipla, Torrent
57 Tepmetko Tepotinib Non-Small Cell Lung Cancer Small US8921357 May 30, 2028 EMD Serono Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8329692 October 30, 2029 Zydus, Glenmark, MSN, Dr Reddy, Natco
US8580781 March 19, 2030
58 Kisqali Ribociclib Breast Cancer Small US8324225 June 17, 2028 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8415355 August 21, 2029 Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
US8685980 May 25, 2030
US9193732 November 9, 2031
59 Osmoprep Sodium Phosphate Constipation Small US7687075 June 22, 2028 Salix Pharmaceuticals Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Saline Laxatives
Monobasic Monohydrate Macleods, Mankind, Cipla, Torrent
/ Sodium Phosphate
Dibasic Anhydrous
60 Rozlytrek Entrectinib Non-Small Cell Lung Cancer Small US9029356 July 8, 2028 Genentech Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8299057 March 1, 2029 Zydus, Glenmark, MSN, Dr Reddy, Natco
US9085565 May 22, 2033
US10738037 May 18, 2037
61 Minivelle Estradiol Menopause Small US9724310 July 10, 2028 Noven Pharmaceuticals Bayer Zydus, Abbott, Bharat Serum & Vaccine, Transdermal Estrogenic Steroid
US8231906 July 4, 2030 Emcure, Mylan, Serum Institute of India, Intas
62 Truseltiq Infigratinib Cholangiocarcinoma Small US9067896 August 6, 2028 Helsinn Healthcare Sa Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitors
US8552002 August 25, 2029 Macleods, Mankind, Cipla, Torrent
63 Syndros Dronabinol Nausea And Vomiting Caused By Chemotherapy Small US9345771 August 6, 2028 Benuvia Therapeutics Inc Dr Reddy's, Glenmark, Torrent, Alkem Oral Cannabinoids
US8222292 August 6, 2028
US10265293 August 6, 2028
US11253472 August 6, 2028
64 Vizimpro Dacomitinib Non-Small Cell Lung Cancer Small US7772243 August 26, 2028 Pfizer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
65 Viekira Pak Ombitasvir/Paritaprevir/ Hepatitis C Small US8501238 September 17, 2028 Abbvie Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Hepatitis C Virus (HCV) NS5A Inhibitor / Acylsulfonamide
Ritonavir US8188104 May 17, 2029 Macleods, Mankind, Cipla, Torrent Inhibitor / Protease Inhibitors
US8642538 September 10, 2029
US8420596 April 10, 2031
US8691938 April 13, 2032
66 Epclusa Sofosbuvir/Velpatasvir Hepatitis C Small US8580765 September 21, 2028 Gilead Sciences Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Nucleotide Polymerase Inhibitor / HCV NS5A Replication
US8334270 September 21, 2028 Macleods, Mankind, Cipla, Torrent Complex Inhibitors
US9085573 September 21, 2028
US7964580 September 26, 2029
US8633309 September 26, 2029
US9284342 March 13, 2031
US8618076 June 11, 2031
US8575135 May 16, 2033
US8921341 May 16, 2033
US8940718 May 16, 2033
67 Lyrica Pregabalin Fibromyalgia, Diabetic Nerve Pain, Spinal Cord Small US8044227B2 October 10, 2028 pfizer Dr Reddy's, Sun, Torrent, Intas, Unichem, La Renon, Capsule/Oral Solution Alpha-2 Delta Ligand
Injury Nerve Pain, Pain After Shingles, Partial Icon, IPCA
Onset Seizure
68 Inqovi Decitabine/Cedazuridine Myelodysplastic Syndromes (MDS) And Chronic Small US9567363 October 16, 2028 Otsuka Phamaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Hypomethylation Agents / Cytidine Deaminase Inhibitors
Myelomonocytic Leukemia (CMML) US8268800 August 22, 2030 Co Ltd Macleods, Mankind, Cipla, Torrent
69 Erivedge Vismodegib Basal-Cell Carcinoma Small US7888364 November 11, 2028 Genentech Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Hedgehog Pathway Inhibitors
Macleods, Mankind, Cipla, Torrent
70 Zemdri Plazomicin Urinary Tract Infection Small US9688711 November 21, 2028 Cipla USA inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Aminoglycoside Antibiotic
US8383596 June 2, 2031 Macleods, Mankind, Cipla, Torrent
71 Remodulin Treprostinil Pulmonary Arterial Hypertension Small US9604901 December 15, 2028 Biochem Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous, Prostacyclin Vasodilator
US9593066 December 15, 2028 Industries Macleods, Mankind, Cipla, Torrent Subcutaneous
72 Vraylar Cariprazine Schizophrenia, Bipolar Mania, And Bipolar Small US7943621 December 16, 2028 Allergan Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotics
Depression US7737142 September 17, 2029 India, Reliance Formulation
73 Procysbi Cysteamine Bitartrate Cystinosis Small US9925158 January 26, 2027 Horizon Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Eye Drops Mercaptoethylamine Compound
US9925157 January 26, 2027 Macleods, Mankind, Cipla, Torrent
US9925156 January 26, 2027
74 Ongentys Opicapone Parkinson's Disease Small US8907099 May 12, 2027 Neurocrine Biosciences, Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Oral Peripheral, Selective, And Reversible
US8168793 April 2, 2029 Inc Formulation Catechol-O-Methyltransferase (Comt) Inhibitor
US9630955 December 12, 2032
75 Iclusig Ponatinib Hydrochloride Chronic Myeloid Leukemia (CML) And Small US8114874 January 24, 2027 Takeda Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitors
Philadelphia Chromosome-Positive (Ph+), Acute US9493470 December 12, 2033 Macleods, Mankind, Cipla, Torrent
Lymphoblastic Leukemia (ALL). US11192897 December 12, 2033
76 Ovide Malathion Pediculosis Small US7560445 February 1, 2027 Taro Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Organophosphate Agent
Macleods, Mankind, Cipla, Torrent
77 Altabax Retapamulin Impetigo Small US7875630 February 14, 2027 GlaxoSmithKline Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Pleuromutilin Antibacterial
Macleods, Mankind, Cipla, Torrent
78 Stribild Elvitegravir/Cobicistat/Em HIV/AIDS Small US7176220 February 27, 2027 Gilead Sciences Inc Cipla, Emcure Pharma, Sun Pharma Oral Antivirals
tricitabine/Tenofovir US7635704 April 26, 2027
Disoproxil US8981103 April 26, 2027
79 Duavee Conjugated Hot Flashes, Osteoporosis Small US7683051 March 10, 2027 Wyeth Pharmaceuticals Alkem, Bayer Zydus, Abbott, Bharat Serum & Oral Hormones / Selective Estrogen Receptor Modulators
Estrogens/Bazedoxifene Llc Vaccine, Emcure, Mylan, Serum Institute of India, (Serms)
Intas
80 Zolinza Vorinostat Cutaneous T Cell Lymphoma Small US7456219 March 11, 2027 Merck & Co Natco, Dr Reddy's, sun pharma, Cipla, Panacea Oral Histone Deacetylase Inhibitors
Biotec, United Bioted, Intas Pharma, SR pharma,
Zydus Cadila
81 Erleada Apalutamide Prostate Cancer Small US9388159 March 27, 2027 Janssen-Cilag BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Androgen Receptor Inhibitors
US8445507 September 15, 2030 International NV Zydus, Glenmark, MSN, Dr Reddy, Natco
US9481663 June 4, 2033
82 Varubi Rolapitant Hydrochloride Nausea And Vomiting Caused By Chemotherapy Small US8178550 April 4, 2027 Tesaro Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Antiemetics
US7049320 August 19, 2028 Macleods, Mankind, Cipla, Torrent
83 Symdeko Tezacaftor-Ivacaftor Cystic Fibrosis Small US10239867 April 9, 2027 Vertex Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Cystic Fibrosis Transmembrane Conductance Regulator
US8623905 May 1, 2027 Macleods, Mankind, Cipla, Torrent Correctors / Cystic Fibrosis Transmembrane Conductance
US7645789 May 1, 2027 Regulator Potentiators
US7776905 June 3, 2027
84 Synjardy Empagliflozin/Metformin Type 2 Diabetes Small US7713938 April 15, 2027 Boehringer Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Enzyme Inhibitor/Biguanide Class
US7579449 August 1, 2028 Ingelheim/Eli Lilly And Medipol, Zydus, Aristo and Quest Pharma
Company
85 Savaysa Edoxaban Tosylate Venous Thromboembolism Small US7365205 April 18, 2027 DaiiChi Sankyo Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Factor Xa Inhibitor
Laboratories, Intas, Zydus Cadila, Alkem
86 Amyvid Florbetapir (18f) Alzheimer's Disease Small US8506929 April 30, 2027 Avid Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Radiopharmaceutical compound
US7687052 April 30, 2027 Radiopharmaceuticals Macleods, Mankind, Cipla, Torrent
Inc
87 Mekinist Trametinib Dimethyl Melanoma Small US7378423 May 29, 2027 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
Sulfoxide Macleods, Mankind, Cipla, Torrent
88 Altavera/Alysena/Ame Ethinylestradiol/Levonorg Contraception Small US7838042 June 1, 2027 Bayer Healthcare Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Oral Contraceptives / Progestins
thyst estrel Pharmaceuticals Inc Macleods, Mankind, Cipla, Torrent
89 Antizol Fomepizole Ethylene Glycol And Methanol Poisoning Small US7553863 June 30, 2027 Paladin Labs Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Competitive Inhibitor Of Alcohol Dehydrogenase
Macleods, Mankind, Cipla, Torrent
90 Vokanamet Canagliflozin/Metformin Type 2 Diabetes Small US7943788 July 14, 2027 Janssen-Cilag Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Intravenous Sodium-Glucose Co-Transporter 2 Inhibitors / Biguanide
Hydrochloride US8513202 December 3, 2027 International NV Medipol, Zydus, Aristo and Quest Pharma Class
US7943582 February 26, 2029
91 Asacol/Lialda/Pentasa Mesalazine Ulcerative Colitis And Crohn's Disease Small US7645801 July 24, 2027 Tillotts Pharma Ag. Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral, Rectal Aminosalicylates
Medipol, Zydus, Aristo and Quest Pharma
92 Daklinza Daclatasvir Hydrochloride Hepatitis C Small US9421192 August 8, 2027 Bristol-Myers Squibb Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Direct-Acting Antiviral Agent Against Hepatitis C Virus (HCV)
US8642025 August 11, 2027 Macleods, Mankind, Cipla, Torrent
US8329159 July 24, 2029
US8629171 June 13, 2031
93 Xtandi Enzalutamide Prostate Cancer Small US7709517 August 13, 2027 Astellas Pharma Inc. BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Androgen Receptor Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
94 Azilect Rasagiline Mesylate Parkinson's Disease Small US7815942 August 27, 2027 Teva Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Monoamine Oxidase Type B Inhibitors
Macleods, Mankind, Cipla, Torrent
95 Tivicay Dolutegravir Sodium HIV/AIDS Small US8129385 October 5, 2027 Viiv Healthcare Cipla, Emcure Pharma, Sun Pharma Oral HIV Integrase Inhibitors
US9242986 December 8, 2029
US10426780 January 24, 2031
96 Imcivree Setmelanotide Genetic Obesity Small US9458195 October 13, 2027 Rhythm Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Melanocortin 4 Receptor Agonists
US8039435 October 13, 2027 Macleods, Mankind, Cipla, Torrent
97 Xcopri Cenobamate Partial Epilepsies Small US7598279 October 30, 2027 SK Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Anticonvulsants
Macleods, Mankind, Cipla, Torrent
98 Pylarify Piflufolastat F-18 Prostate Cancer Metastasis Small US8487129 November 7, 2027 Progenics BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Radioactive Diagnostic Agent
US9861713 July 31, 2029 Pharmaceuticals Zydus, Glenmark, MSN, Dr Reddy, Natco
US8778305 September 21, 2030
US10947197 June 9, 2037
99 Korsuva Difelikefalin Itching Small US10793596 November 12, 2027 Cara Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Kappa Opioid Receptor Agonists
US10017536 November 12, 2027 Macleods, Mankind, Cipla, Torrent
US8536131 November 12, 2027
US7727963 November 12, 2027
US7713937 November 12, 2027
US7402564 November 12, 2027
100 Empaveli Pegcetacoplan Paroxysmal Nocturnal Hemoglobinuria Small US9169307 November 18, 2027 Apellis Pharmaceuticals/ Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Pegylated C3 Inhibitor
US7989589 December 4, 2027 Swedish Orphan Macleods, Mankind, Cipla, Torrent
US7888323 December 4, 2027 Biovitrum
US10125171 August 2, 2033
US10875893 November 15, 2033
US10035822 November 15, 2033
101 Tabrecta Capmatinib Hydrochloride Non-Small Cell Lung Cancer Small US8461330 November 19, 2027 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Subcutaneous Kinase Inhibitors
US7767675 November 19, 2027 Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
US8420645 June 5, 2031
US10596178 July 22, 2035
102 Turalio Pexidartinib Tenosynovial Giant Cell Tumor Small US9169250 November 21, 2027 DaiiChi Sankyo Company BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Subcutaneous Kinase Inhibitors
Hydrochloride US8404700 November 21, 2027 Zydus, Glenmark, MSN, Dr Reddy, Natco
US8722702 November 21, 2027
US7893075 October 13, 2028
US10730876 May 5, 2036
US9802932 May 5, 2036
103 Toradol/Biorolac Ketorolac Tromethamine Pain Small US8008338 November 24, 2027 Cadila Healthcare Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral, Intramuscular, Nonsteroidal Anti-Inflammatory Drug Class
US7842714 August 15, 2029 Limited Alembic Intravenous, Eye
Drops, Nasal Spray
104 Entresto Sacubitril/Valsartan Heart Failure Small US8877938 November 24, 2027 Novartis Dr Reddy's, Leeford, Glenmark, Intas, Natco, Oral Neprilysin Inhibitors / Angiotensin II Receptor Blocker
August 15, 2029 Pharmaceuticals Corp Macleods
105 Xermelo Telotristat Ethyl Carcinoid Syndrome Diarrhea Small US7709493 December 11, 2027 Lexicon Pharmaceuticals Sun Pharma, Lupin, Mankind, Dr Reddy's, Torrent, Oral Tryptophan Hydroxylase Inhibitor
US7553840 December 11, 2027 Alembic, Cipla, Alkem, Zydus Cadila
US8193204 February 27, 2031
106 Jakafi Ruxolitinib Phosphate Myelofibrosis Small US8415362 December 24, 2027 Incyte Corp/Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Topical Janus Kinase Inhibitor
US7598257 December 24, 2027 Macleods, Mankind, Cipla, Torrent
US8722693 June 12, 2028
107 Nexavar Sorafenib Tosylate Renal Cell Carcinoma Small US8877933 December 24, 2027 Bayer/Onyx Natco, Bayer Zydus, Cipla, Arechar, Intas, Hetero Oral, Topical Kinase Inhibitors
Pharmaceuticals
108 Avycaz Ceftazidime / Avibactam Intra-Abdominal Infections, Urinary Tract Small US7112592 January 7, 2026 Allergan Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Infusion Cephalosporin / Beta-Lactamase Inhibitors
Sodium Infections, And Pneumonia US8471025 August 12, 2031 Macleods, Mankind, Cipla, Torrent
US9284314 June 15, 2032
US9695122 June 15, 2032
US8969566 June 15, 2032
109 Tavalisse Fostamatinib Sodium Chronic Immune Thrombocytopenia Small US8211889 January 19, 2026 Rigel Pharmaceuticals Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Kinase Inhibitors
US7538108 March 28, 2026 Laboratories, Intas, Zydus Cadila, Alkem
US7989448 June 12, 2026
US8163902 June 17, 2026
US7449458 September 4, 2026
110 Bridion Sugammadex Sodium Reversal Of Neuromuscular Blockade Induced Small USRE44733 January 27, 2026 Merck & Co Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Intraveous Selective Relaxant Binding Agent
By Rocuronium Formulation
111 Briviact Brivaracetam Partial-Onset Seizures In People 1 Month Of Small US6911461 February 21, 2026 UCB Group Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Anticonvulsant
Age And Older Macleods, Mankind, Cipla, Torrent
112 Procoralan Ivabradine Symptomatic Management Of Stable Small US7361650 February 22, 2026 Servier Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Hyperpolarization-Activated Cyclic Nucleotide-Gated (HCN)
Heart-Related Chest Pain And Heart Failure US7361649 February 22, 2026 Alembic Channel Blocker
US7879842 February 22, 2026
US7867996 December 12, 2026
113 Pradaxa Dabigatran Blood Clots, Stroke Small US7932273 March 7, 2026 Boehringer Ingelheim Cipla, Emcure, Natco, Intas, La Renon, Cadila, Oral Direct Thrombin Inhibitors
Torrent, Sun pharma
114 Ozempic Semaglutide Type 2 Diabetes Small US8536122 March 20, 2026 Nov Nordisk Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral, Subcutaneous Glucagon-Like Peptide-1 Receptor Agonist
US8129343 December 5, 2031 Medipol, Zydus, Aristo and Quest Pharma
115 Byetta/Bydureon Exenatide Synthetic Type 2 Diabetes Small US6515117 April 4, 2026 Astrazeneca Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Subcutaneous Glucagon-Like Peptide-1 Receptor Agonist
Medipol, Zydus, Aristo and Quest Pharma
116 Rexulti Brexpiprazole Schizophrenia, Major Depressive Disorder Small US7888362 April 12, 2026 Otsuka America Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotics
USRE48059 December 23, 2028 Phamaceuticals Co Ltd India, Reliance Formulation
117 Aveed / Jatenzo Nebido (Testosterone Low Testosterone Levels In Men Small US11179402 April 14, 2026 Endo Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Cipla, Leeford, Oral, Intramuscular Androgens, 3-Oxoandrosten (4) Derivative
Undecanoate) US10617696 April 12, 2030 Inc Intas Injection
118 Aptiom Eslicarbazepine Acetate Partial-Onset Seizures Epilepsy Small US9206135 April 21, 2026 Sumitomo Pharma Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Aromatic Anticonvulsant
Macleods, Mankind, Cipla, Torrent
119 Vocabria Cabotegravir HIV/AIDS Small US8410103 April 28, 2026 Viiv Healthcare Cipla, Emcure Pharma, Sun Pharma Oral, Intramascular HIV Integrase Inhibitors
US10927129 April 28, 2026 Injection
120 Jevtana Cabazitaxel Metastatic Castration-Resistant Prostate Cancer Small US7241907 June 10, 2026 Sanofi-Aventis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Taxane And Antineoplastic Agent
Zydus, Glenmark, MSN, Dr Reddy, Natco
121 Voltaren Diclofenac Inflammatory Disease Such As Gout Small US8097651 June 16, 2026 GSK Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Rectal, Non-Steroidal Anti-Inflammatory Drug
US7759394 June 16, 2026 Macleods, Mankind, Cipla, Torrent Intramuscuar,
Intravenous, Topical
122 Trintellix Vortioxetine Major Depressive Disorder Small US7144884 June 17, 2026 Takeda Pharmcaceuticals Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Serotonin Modulator
Hydrobromide US8722684 June 30, 2031 India, Reliance Formulation
123 Zelboraf Vemurafenib Late Stage Melanoma Small US8143271 June 21, 2026 Genentech Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
US7504509 October 22, 2026 Macleods, Mankind, Cipla, Torrent
US7863288 June 20, 2029
US8741920 July 27, 2030
124 Rhopressa Netarsudil Mesylate Glaucoma Small US8450344 July 11, 2026 Aerie Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Eye Drops, Topical Kinase Inhibitor
US9096569 July 11, 2026 Macleods, Mankind, Cipla, Torrent
US10174017 January 27, 2030
US10654844 January 27, 2030
US8394826 November 10, 2030
US9931336 March 14, 2034
US10588901 March 14, 2034
US9415043 March 14, 2034
125 Gilotrif Afatinib Dimaleate Non-Small Cell Lung Cancer Small USRE43431 July 13, 2026 Boehringer Ingelheim BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Tyrosine Kinase Inhibitor
US8426586 April 10, 2030 Zydus, Glenmark, MSN, Dr Reddy, Natco
126 Beleodaq Belinostat Hematological Malignancies And Solid Tumor Small US6888027 August 10, 2026 Acrotech Biopharma BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Histone Deacetylase Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
127 Cometriq Cabozantinib S-Malate Medullary Thyroid Cancer, Renal Cell Small US7579473 August 14, 2026 Exelixis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Tyrosine Kinase Inhibitor
Carcinoma, And Hepatocellular Carcinoma US11091439 January 15, 2030 Zydus, Glenmark, MSN, Dr Reddy, Natco
US8877776 October 8, 2030
128 Isturisa Osilodrostat Phosphate Cushing’s Disease Small US8835646 August 23, 2026 Recordati Rare Diseases Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral 11beta-Hydroxylase (Cyp11b1) Inhibitor
US8314097 March 27, 2029 Inc Macleods, Mankind, Cipla, Torrent
US9434754 January 13, 2031
129 Samsca Tolvaptan Hyponatremia Small US8501730 September 1, 2026 Otsuka America Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Vasopressin V2 Receptor Antagonist
Phamaceuticals Co Ltd Macleods, Mankind, Cipla, Torrent
130 Sprycel Dasatinib Chronic Myelogenous Leukemia (CML) And Small US7491725 September 28, 2026 Bristol-Myers Squibb Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
Acute Lymphoblastic Leukemia Macleods, Mankind, Cipla, Torrent
131 Aklief Trifarotene Acne Vulgaris Small US7807708 October 1, 2026 Galderma Laboratories Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Retinoic Acid Receptor Agonist
Macleods, Mankind, Cipla, Torrent
132 Symproic Naldemedine Tosylate Opioid-Induced Constipation Small USRE46375 October 5, 2026 Shionogi & Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Peripherally Acting Mu-Opioid Receptor Antagonist
USRE46365 January 11, 2028 Macleods, Mankind, Cipla, Torrent
US9108975 November 11, 2031
US10952968 May 13, 2033
133 Saphris Asenapine Schizophrenia Small USRE46375 October 5, 2026 Merck sharp & Dohme Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Sublingual Atypical Antipsychotic
USRE46365 January 11, 2028 India, Reliance Formulation
US9108975 November 11, 2031
US10952968 May 13, 2033
134 Uptravi Selexipag Pulmonary Arterial Hypertension Small US7205302 October 31, 2026 Actelion Pharmaceuticals Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Oral, Intravenous Selective Nonprostanoid IP Prostacyclin Receptor Agonists
US8791122 August 1, 2030 Alembic
135 Bevyxxa Betrixaban Venous Thrombosis Small US7598276 November 8, 2026 Portola Pharmaceuticals Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Direct Factor Xa Inhibitor Anticoagulant
Laboratories, Intas, Zydus Cadila, Alkem
136 Orkambi Lumacaftor / Ivacaftor Cystic Fibrosis Small US9216969 November 8, 2026 Vertex Pharmaceutical Lupin, Glenmark, Oral Cystic Fibrosis Transmembrane Conductance Regulator
US10597384 December 4, 2028 Corrector / Cystic Fibrosis Transmembrane Conductance
US8507534 September 20, 2030 Regulator Potentiators
137 Eliquis Apixaban Blood Clots Small US6967208 November 21, 2026 Bristol-Myers Squibb Co Cipla, Emcure, Natco, Intas, La Renon, Cadila, Oral Factor Xa Inhibitors
Torrent, Sun Pharma, Micro Labs
138 Calquence Acalabrutinib Non-Hodgkin Lymphoma, Mantle Cell Small US7459554 November 24, 2026 Astrazeneca Natco, Dr Reddy's, sun pharma, Cipla, Panacea Oral Kinase Inhibitors
Lymphoma US9290504 July 11, 2032 Biotec, United Bioted, Intas Pharma, SR pharma,
US9796721 July 1, 2036 Zydus Cadila
139 Sirturo Bedaquiline Multi-Drug-Resistant Tuberculosis Small US7498343 December 1, 2026 Janssen Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Anti-Mycobacterials
US8546428 March 19, 2029 Macleods, Mankind, Cipla, Torrent
140 Adempas Riociguat Pulmonary Hypertension Small US7173037 December 4, 2026 Bayer Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Oral SGC Stimulators
US10662188 February 18, 2034 Alembic
US11203593 February 18, 2034
141 Moxatag Amoxicillin Bacterial Infection Small US8778924 December 8, 2026 Pragma Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Penicillin-Like Antibiotics
Macleods, Mankind, Cipla, Torrent
142 Inrebic Fedratinib Myeloproliferative Small US7528143 December 16, 2026 Impact Biomedicines Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Tyrosine Kinase Inhibitor
US7825246 December 16, 2026 Macleods, Mankind, Cipla, Torrent
143 Imbruvica Ibrutinib Chronic Lymphocytic Leukemia Small US8697711 December 28, 2026 Janssen Biotech Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
US9181257 December 28, 2026 Macleods, Mankind, Cipla, Torrent
US8957079 December 28, 2026
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US7514444 December 28, 2026
US8008309 November 13, 2027
US10125140 June 3, 2033
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US10106548 June 3, 2033
US9296753 October 30, 2033
144 Kalydeco Ivacaftor Cystic Fibrosis Small US8754224 December 28, 2026 Vertex Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Cystic Fibrosis Transmembrane Conductance Regulator
US7495103 May 20, 2027 Macleods, Mankind, Cipla, Torrent Potentiator
145 Xalkori Crizotinib Non-Small Cell Lung Cancer Small US8785632 March 01, 2025 Pfizer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitor
US7230098 August 26, 2025 Zydus, Glenmark, MSN, Dr Reddy, Natco
US7858643 October 8, 2029
US8217057 November 6, 2029
146 Omegaven Fish Oil Triglycerides Parenteral Nutrition-Associated Cholestasis Small US9566260 July 11, 2025 Fresenius Kabi USA LLC Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous; Emusion Antilipemic Agent
US9629821 July 11, 2025 Macleods, Mankind, Cipla, Torrent
US10350186 November 05, 2024
147 Yupelri Revefenacin Chronic Obstructive Pulmonary Disease Small US7491736 March 10, 2025 Mylan Ireland Ltd Zydus Cadila, Abbott, Sun Pharma, Zuventus, Solution; Inhalation Anticholinergics
US7521041 March 10, 2025 Macleods, Mankind, Cipla, Torrent
US7550595 March 10, 2025
US7585879 March 10, 2025
US7910608 March 10, 2025
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US9765028 July 14, 2030
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148 Sprycel Dasatinib Chronic Myeloid Leukemia (CML), Acute Small US8680103 February 04, 2025 Bristol-Myers Squibb Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
Lymphoblastic Leukemia (ALL) Macleods, Mankind, Cipla, Torrent
149 Bosulif Bosutinib Monohydrate Chronic Phase Philadelphia Small US7417148 December 11, 2025 PF Prism CV Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Tyrosine Kinase Inhibitor
Chromosome-Positive Chronic Myelogenous US7767678 November 23, 2026 Macleods, Mankind, Cipla, Torrent
Leukemia US7919625 December 11, 2025
150 Cresemba Isavuconazonium Sulfate Invasive Aspergillosis And Mucormycosis Small US6812238 October 31, 2025 Astellas Pharma US Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Azole Antifungal
Macleods, Mankind, Cipla, Torrent
151 Antara Fenofibrate High Cholesterol And Triglycerides (Fatty Acids) Small US8026281 April 22, 2025 Lupin Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Antilipemic Agent
In Blood Macleods, Mankind, Cipla, Torrent
152 Lysteda Tranexamic Acid Cyclic Heavy Menstrual Bleeding Small US7947739 March 04, 2025 Amring Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Antifibrinolytic
US8022106 March 04, 2025 Inc Macleods, Mankind, Cipla, Torrent
US8273795 March 04, 2025
US8487005 March 04, 2025
US8791160 March 04, 2025
US8809394 March 04, 2025
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153 Bepreve Bepotastine Besilate Itching Of The Eyes Due To Allergies Small US8784789 January 13, 2025 Bausch And Lomb Inc Sun Pharma, Cipla, Lupin, Intas Eye Drops Histamine 1 (H1) Receptor Agonist
US8877168 July 30, 2023
154 Sancuso Granisetron Nausea And Vomiting Caused By Chemotherapy Small US7608282 January 22, 2025 Kyowa Kirin Inc Dr Reddy's, Glenmark, Torrent, Alkem Transdermal 5-HT3 Receptor Antagonist
155 Nucynta Tapentadol Hydrochloride Moderate To Severe Pain Small US7994364 June 27, 2025 Collegium Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Opiate (Narcotic) Analgesic
Pharmaceuticals Alembic
156 Nexlizet Bempedoic Acid, Reduce The Amount Of Cholesterol And Other Small US7335799 December 03, 2025 Esperion Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Adenosine Triphosphate-Citrate Lyase Inhibitor / Selective
Ezetimibe Fatty Substances In Blood Inc Macleods, Mankind, Cipla, Torrent Cholesterol-Absorption Inhibitor
157 Vyzulta Latanoprostene Bunod Intraocular Pressure In Patients With Small US8058467 January 5, 2025 Bausch And Lomb Inc Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Eye Drops Prostaglandin Analog
Open-Angle Glaucoma Or Ocular Hypertension US7910767 January 5, 2025 Alembic
US7273946 October 3, 2025
158 Trilipix Fenofibrate Abnormal Blood Lipid Levels Small US7259186 January 7, 2025 Abbvie Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Antilipemic Agent
Macleods, Mankind, Cipla, Torrent
159 Duaklir Aclidinium Chronic Obstructive Pulmonary Disease Small USRE46417 February 10, 2025 Almirall, SA Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Bronchodilators / Long-Acting Beta Agonist
Bromide/Formoterol Macleods, Mankind, Cipla, Torrent
160 Arcapta Indacaterol Chronic Obstructive Pulmonary Disease Small US6878721 February 25, 2025 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Long-Acting Beta Agonists
Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
161 Rukobia Fostemsavir HIV/AIDS Small US8461333 February 25, 2025 Viiv Healthcare Cipla, Emcure Pharma, Sun Pharma Oral HIV Attachment Inhibitor
US7745625 November 19, 2027
162 Incivek Telaprevir Hepatitis C Small US7820671 February 25, 2025 Johnson & Johnson Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Direct-Acting Antiviral
Macleods, Mankind, Cipla, Torrent
163 Viberzi Eluxadoline Diarrhea And Abnormal Pain Small US10213415 March 14, 2025 Allergan Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Mu-Opioid Receptor Agonist
US8609709 March 14, 2025 Alembic
US7786158 March 14, 2025
US9115091 July 7, 2028
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US7741356 May 27, 2029
164 Glucophage Metformin Type 2 Diabetes Small US7780987 March 23, 2025 Merck & Co Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Biguanide
Medipol, Zydus, Aristo and Quest Pharma
165 Roxicodone Oxycodone Moderate To Severe Pain Small US10696684 March 30, 2025 Xanodyne Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral, Sublingual, Opiate (Narcotic) Analgesic
US10407434 March 30, 2025 Pharmaceuticals Alembic Intramuscular,
US9522919 March 30, 2025 Intravenous,
US9073933 March 30, 2025 Intranasal,
Subcutaneous,
Transdermal, Rectal,
Epidural
166 Tegsedi Inotersen Nerve Damage In Adults With Hereditary Small US8101743 April 1, 2025 Akcea Therapeutics, Inc. Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Transthyretin-Directed Antisense Oligonucleotide
Transthyretin-Mediated Amyloidosis US9061044 April 29, 2031 Macleods, Mankind, Cipla, Torrent
167 Reyvow Lasmiditan Migraine With Or Without Aura Small US7423050 April 6, 2025 Eli Lily and Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Selective Serotonin Receptor Agonist
US11053214 December 5, 2037 Macleods, Mankind, Cipla, Torrent
168 Humira Adalimumab Arthritis, Plaque Psoriasis, Hidradenitis Large US6090382A December 31, 2016 AbbVie Intas, Cipla, Reliance , Lupin Injection Tumor Necrosis Factor Blockers
Suppurativa, Crohn’s Disease, Ankylosing US9187559B2 April 11, 2025
Spondylitis, Ulcerative Colitis, Non-Infectious US8969024B2 May 10, 2032
Uveitis US9315574B2 November 12, 2033
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169 Kyprolis Carfilzomib Relapsed Or Refractory Multiple Myeloma Small US8207125 April 14, 2025 Amgen Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Intravenous Proteasome Inhibitor
US7232818 April 14, 2025 Biotec, United Biotech, Intas Pharma, SR Pharma,
US8207297 April 14, 2025 Zydus Cadila
US7417042 July 20, 2026
170 Biktarvy Bictegravir/Emtricitabine/ HIV/AIDS Small US7390791 April 17, 2025 Gilead Sciences Inc Cipla, Emcure Pharma, Sun Pharma Oral Nucleoside Reverse Transcriptase Inhibitors
Tenofovir Alafenamide US9296769 August 15, 2032
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US9708342 June 19, 2035
171 Stendra Avanafil Erectile Dysfunction Small US6656935 April 27, 2025 Vivus Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Phosphodiesterase Inhibitor
Macleods, Mankind, Cipla, Torrent
172 Inlyta Axitinib Renal Cell Carcinoma Small US6534524 April 29, 2025 Pfizer Natco, Bayer Zydus, Cipla, Arechar, Intas, Hetero Oral Kinase Inhibitor
US8791140 December 14, 2030
173 Camptosar Irinotecan Colon Cancer And Small Cell Lung Cancer Small US9782349 May 2, 2025 Pfizer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous DNA Topoisomerase I Inhibitor
US9724303 May 2, 2025 Zydus, Glenmark, MSN, Dr Reddy, Natco
US8992970 May 2, 2025
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174 Jentadueto Linagliptin/Metformin High Blood Sugar Levels Caused By Type 2 Small US7407955 May 2, 2025 Boehringer Ingelheim Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Dipeptidyl Peptidase-4 Inhibitor / Biguanides
Hydrochloride Diabetes Medipol, Zydus, Aristo and Quest Pharma
175 Pexeva Paroxetine Mesylate Symptoms Of Menopause Small US7598271 May 4, 2025 Sabela Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Selective Serotonin Reuptake Inhibitor
US8946251 August 4, 2026 Macleods, Mankind, Cipla, Torrent
US8658663 April 6, 2029
176 Doptelet Avatrombopag Thrombocytopenia Associated With Chronic Small US7638536 May 5, 2025 AkaRx Inc Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Thrombopoietin Receptor Agonist
Liver Disease Laboratories, Intas, Zydus Cadila, Alkem
177 Lymphoseek Technetium Tc 99m Identify Sentinel Lymph Nodes Small US6409990 May 12, 2025 Navidea Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Radiologic Conjugating Agent
Tilmanocept US9439985 September 27, 2033 Biopharmaceuticals Macleods, Mankind, Cipla, Torrent
178 Olysio Simeprevir Hepatitis C Small US7671032 May 19, 2025 Johnson & Johnson Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Serine Protease Inhibitor
US8349869 July 28, 2026 Macleods, Mankind, Cipla, Torrent
US8754106 July 28, 2026
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179 Edarbi Azilsartan Hypertension Small US7157584 May 22, 2025 Takeda Pharmaceutical Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Oral Angiotensin-Receptor Blocking
Alembic
180 Onpattro Patisiran Polyneuropathy In People With Hereditary Small US8334373 May 27, 2025 Alnylam Pharmaceutical Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Intravenous RNA Interference Therapeutic Class
Transthyretin-Mediated Amyloidosis US8168775 October 20, 2029 Formulation
US10240152 October 20, 2029
US11079379 August 27, 2035
181 Diprivan Propofol Used To Help Patients Relax Before And During Small US8476010 June 1, 2025 Fresenius Kabi USA LLC Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Non-Barbiturate Sedative
General Anesthesia For Surgery Macleods, Mankind, Cipla, Torrent
182 Kazano Alogliptin/Metformin Blood Sugar Control In Adults With Type 2 Small US8288539 June 24, 2025 Takeda Pharmaceutical Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Selective Dpp-4 Inhibitor / Biguanide
Diabetes US7807689 June 27, 2028 Medipol, Zydus, Aristo and Quest Pharma
183 Amondys 45 Casimersen Duchenne Muscular Dystrophy (DMD) Small US9447415 June 28, 2025 Sarepta Therapeutics. Macleods, Zuventus,, Mankind, Alkem, Aristo, Intravenous Antisense Oligonucleotide Of The Phosphorodiamidate
US8524880 April 2, 2026 Lupin, IPCA Morpholino Oligomer Subclass
US10287586 November 12, 2030
US9228187 November 12, 2030
184 Exondys 51 Eteplirsen Duchenne Muscular Dystrophy (DMD) Small US10781451 June 28, 2025 Sarepta Therapeutics. Macleods, Zuventus,, Mankind, Alkem, Aristo, Intravenous Synthetic Antisense Oligonucleotide And A
US9018368 June 28, 2025 Lupin, IPCA Phosphorodiamidate Morpholino Oligomer
US9243245 October 27, 2028
185 Vyondys 53 Golodirsen Duchenne Muscular Dystrophy (DMD) Small US10227590 June 28, 2025 Sarepta Therapeutics. Macleods, Zuventus,, Mankind, Alkem, Aristo, Intravenous Synthetic Rna Antisense Oligonucleotide
US9994851 June 28, 2025 Lupin, IPCA
US9024007 June 28, 2025
US10968450 June 28, 2025
US10421966 June 28, 2025
186 Vyleesi Bremelanotide Low Sexual Desire In Women Small US6794489 June 28, 2025 Palatin Technologies Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Melanocortin Receptor Agonists
Macleods, Mankind, Cipla, Torrent
187 Zydelig Idelalisib Blood Cancer Small USRE44638 August 5, 2025 Gilead Sciences Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Phosphoinositide 3-Kinase Inhibitor
US8865730 March 5, 2033 Zydus, Glenmark, MSN, Dr Reddy, Natco
US10730879 March 5, 2033
US9469643 September 2, 2033
188 Duzallo Lesinurad/Allopurinol Gout Small US8003681 August 25, 2025 Astrazeneca Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Triazoles / Xanthine Oxidase Inhibitor
US8546436 February 29, 2032 Macleods, Mankind, Cipla, Torrent
189 Prolensa Bromfenac Ocular Inflammation And Pain After Cataract Small US8129431 September 11, 2025 Bausch And Lomb Inc Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Eyedrops Nonsteroidal Anti-Inflammatory Drugs
Surgery Alembic
190 Nuplazid Pimavanserin Parkinson's Disease Psycosis Small US7923564 September 26, 2025 Acadia Pharmaceuticals Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotic
US7732615 June 3, 2028 India, Reliance Formulation
US7601740 April 29, 2030
191 Baxdela Delafloxacin Acute Bacterial Skin And Skin Structure Small US9539250 October 7, 2025 Melinta Therapeutics Cipla, Mylan, Zydus Cadila, Alkem, United Biotech Oral, Intravenous Fourth Generation Fluoroquinolone
Infections US8273892 August 6, 2026
US7728143 November 20, 2027
US8871938 September 23, 2029
USRE46617 December 28, 2029
192 Lenvima Lenvatinib Thyroid Cancer Small US7253286 October 24, 2025 Eisai Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitor
US7612208 September 19, 2026 Zydus, Glenmark, MSN, Dr Reddy, Natco
US11186547 August 26, 2035
US10407393 August 26, 2035
US10259791 August 26, 2035
193 Cresemba Isavuconazole Aspergillosis And Mucormycosis Small US6812238 October 31, 2025 Astellas Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Triazole
Macleods, Mankind, Cipla, Torrent
194 Lybalvi Olanzapine/Samidorphan Schizophrenia And Bipolar Disorder Small US7262298 November 23, 2025 Alkermes, Inc Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Second-Generation (Atypical) Antipsychotic / Opioid
US9119848 August 30, 2031 India, Reliance Formulation Antagonist
195 Opsumit Macitentan Pulmonary Arterial Hypertension Small US7094781 December 5, 2025 Actelion Pharmaceuticals Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Oral Endothelin Receptor Antagonist
Alembic
196 Latuda Lurasidone Schizophrenia And Bipolar Disorder Small USRE45573 December 23, 2025 Sunovion Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotic
Pharmaceuticals India, Reliance Formulation
197 Klisyri Tirbanibulin Actinic Keratosis Small US8980890 December 28, 2025 Almirall, SA Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Microtubule Inhibitor
US8236799 December 28, 2025 Macleods, Mankind, Cipla, Torrent
US7300931 February 6, 2026
US7851470 February 2, 2029
US10669236 September 7, 2038
198 Signifor Pasireotide Cushing’s Disease Small US8299209 December 27, 2025 Recordati Rare Diseases Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Somatostatin Agonist
US7473761 December 14, 2026 Inc Macleods, Mankind, Cipla, Torrent Injection,
Intramuscular
Injection
199 Mulpleta Lusutrombopag Thrombocytopenia Small US7601746 September 05, 2024 Shionogi & Co Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Thrombopoietin Receptor Agonist
US8889722 July 29, 2028 Laboratories, Intas, Zydus Cadila, Alkem
US8530668 January 21, 2030
200 Invokamet XR Canagliflozin; Metformin Type 2 Diabetes Small US8785403 July 30, 2024 Janssen Pharmaceuticals Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Tablet, Extended Sodium-Glucose Co-Transporter 2 Inhibitor / Biguanide Class
Hydrochloride US8222219 March 11, 2025 Medipol, Zydus, Aristo and Quest Pharma Release; Oral
201 Revlimid Lenalidomide Multiple Myeloma And Myelodysplastic Small US7855217 November 24, 2024 Celgene Corp Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Oral Immunomodulatory Drugs
Syndromes US7465800 April 27, 2027 Biotec, United Biotech, Intas Pharma, SR Pharma,
Zydus Cadila
202 Rydapt Midostaurin Acute Myeloid Leukemia Small US7973031 October 17, 2024 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral; Capsule Kinase Inhibitor
US8222244 October 29, 2022 Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
203 Prevymis Letermovir Cytomegalovirus (CMV) Infection Small US7196086 May 22, 2024 Merck sharp & Dohme Zydus Cadila, Abbott, Sun Pharma, Zuventus, Solution; Intravenous Antivirals
US8513255 May 22, 2024 Macleods, Mankind, Cipla, Torrent
204 Vyndaqel Tafamidis Meglumine Transthyretin Amyloid Polyneuropathy Small US7214695 April 27, 2024 Foldrx Pharmaceuticals Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Capsule; Oral Transthyretin Stabilizer
US7214696 December 19, 2023 Inc Sub Pfizer Inc Formulation
US8168663 December 19, 2023
US8653119 January 28, 2024
205 Lynparza Olaparib Advanced Ovarian Cancer, Fallopian Tube Small US7151102 April 29, 2022 Astrazeneca BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Capsule; Oral Polyadenosine 5'-Diphosphoribose Polymerase (PARP)
Cancer US7449464 October 11, 2024 Zydus, Glenmark, MSN, Dr Reddy, Natco Enzyme Inhibitor
US7981889 October 11, 2024
US8912187 March 12, 2024
206 Tasigna Nilotinib Chronic Myelogenous Leukemia (CML) And Small US7169791 January 04, 2024 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Capsule; Oral Kinase Inhibitor
Acute Lymphoblastic Leukemia US8415363 January 18, 2027 Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
US8163904 February 23, 2029
US9061029 October 7, 2032
207 Xopenex HFA Levalbuterol Tartrate Chronic Obstructive Pulmonary Disease And Small US7256310 October 08, 2024 Sunovion IPCA, Sun Pharma, Intas, Taj Pharma Aerosol, Metered; Beta Agonist
Asthma Pharmaceuticals Inhalation
208 Vandazole Metronidazole Bacterial Vaginosis Small US7456207 September 22, 2024 Teva Pharmaceuticals Abbott, Cadila Gel; Vaginal Nitroimidazole Antimicrobial
209 Prialt Ziconotide Acetate Pain Reliever Small US8653033 October 10, 2024 TerSera Therapeutics Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Injectable; Intrathecal Selective N-Type Voltage-Gated Calcium Channel Blocker
US8765680 October 10, 2024 Alembic
US9707270 October 10, 2024
210 Aloxi Palonosetron Acute Nausea And Vomiting Small US7947724 January 30, 2024 Helsinn Healthcare Sa Dr Reddy's, Glenmark, Torrent, Alkem Intravenous 5-Ht3 Receptor Antagonist
Hydrochloride US7947725 January 30, 2024
US7960424 January 30, 2024
US8518981 January 30, 2024
US8598218 January 30, 2024
US9173942 January 30, 2024
US9439854 January 30, 2024
US9457020 January 30, 2024
211 Dificid Fidaxomicin Clostridioides Difficile-Associated Diarrhea Small US8586551 January 23, 2024 Merck sharp & Dohme Sun Pharma, Lupin, Mankind, Dr Reddy's, Torrent, Oral Macrolide Antibiotics
(CDAD) US7378508 January 31, 2028 Alembic, Cipla, Alkem, Zydus Cadila
US7863249 January 31, 2028
212 Linzess Linaclotide Irritable Bowel Syndrome Small US7371727 January 28, 2024 Allergan Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Guanylate Cyclase-C Receptor Agonist
US7745409 January 28, 2024 Macleods, Mankind, Cipla, Torrent
US8080526 January 28, 2024
US7704947 January 28, 2024
US7304036 August 30, 2026
213 Myfembree Relugolix/Estradiol/Noret Heavy Mentrual Bleeding Small US7300935 January 28, 2024 Myovant Sciences Bayer Zydus, Abbott, Bharat Serum & Vaccine, Oral Gonadotropin-Releasing Hormone Receptor Antagonist /
histerone Acetate US8058280 January 28, 2024 Emcure, Mylan, Serum Institute of India, Intas Estrogenic Steroid / Second-Generation Progestin
214 Auryxia Ferric Citrate Hyperphosphataemia And Iron Deficiency Small US9328133 February 18, 2024 Akebia Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Phosphate Binder
Anaemia US9757416 February 18, 2024 Macleods, Mankind, Cipla, Torrent
US8338642 February 18, 2024
US7767851 February 18, 2024
215 Isentress Raltegravir HIV/AIDS Small US7119093 February 21, 2024 Merck sharp & Dohme Cipla, Emcure Pharma, Sun Pharma Oral HIV Integrase Inhibitor
US6762180 October 1, 2025
216 Zontivity Vorapaxar Peripheral Arterial Disease Small US7304078 April 6, 2024 Merck sharp & Dohme Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Protease-Activated Receptor-1 Antagonist
US7713999 May 30, 2024 Macleods, Mankind, Cipla, Torrent
217 Bosulif Bosutinib Chronic Myelogenous Leukemia Small USRE42376 April 13, 2024 Pfizer Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitor
US7767678 November 23, 2026 Macleods, Mankind, Cipla, Torrent
218 Omontys Peginesatide Anemia Small US7084245 May 12, 2024 Affymax Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous, Erythropoietin
US7414105 May 12, 2024 Macleods, Mankind, Cipla, Torrent Intravenous
US7919118 May 12, 2024
US7528104 May 12, 2024
219 Aliqopa Copanlisib Relapsed Follicular Lymphoma Small US7511041 May 13, 2024 Bayer Natco, Dr Reddy's, sun pharma, Cipla, Panacea Intravenous Kinase Inhibitor
USRE46856 October 22, 2029 Biotec, United Bioted, Intas Pharma, SR pharma,
US10383876 March 29, 2032 Zydus Cadila
220 Mayzent Siponimod Multiple Sclerosis Small US7939519 May 19, 2024 Novartis Sun Pharma, Alkem, Micro Labs, Abbott, Intas, Oral Sphingosine L-Phosphate Receptor Modulator
Pharmaceuticals Corp Lupin, Torrent, IPCA
221 Prevymis Letermovir Cytomegalovirus (CMV) Infection Small US8513255 May 22, 2024 Merck & Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral, Intravenous Antivirals
USRE46791 May 22, 2024 Macleods, Mankind, Cipla, Torrent
222 Xifaxan Rifaximin Traveler's Diarrhea, Irritable Bowel Syndrome, Small US7612199 June 19, 2024 Salix Pharmaceuticals Inc Sun Pharma, Lupin, Mankind, Dr Reddy's, Torrent, Oral Antibiotics
Hepatic Encephalopathy US8835452 June 19, 2024 Alembic, Cipla, Alkem, Zydus Cadila
US8158781 June 19, 2024
US7045620 June 19, 2024
US7902206 June 19, 2024
US7906542 June 1, 2025
US8741904 February 27, 2026
US8193196 September 2, 2027
223 Remodulin/Orenitram Treprostinil Pulmonary Arterial Hypertension Small US9050311 May 24, 2024 United Therapeutics Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Subcutaneous, Vasodilators And Platelet-Aggregation Inhibitor
/Tyvaso US7417070 July 30, 2026 Alembic Intravenous,
US8497393 December 15, 2028 Inhalation, Oral
224 Tpoxx Tecovirimat Orthopoxviruses (Smallpox And Monkeypox) Small US8124643 June 18, 2024 SIGA technologies Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Orthopoxvirus Vp37 Envelope Wrapping Protein Inhibitor
US9339466 March 23, 2031 Macleods, Mankind, Cipla, Torrent
225 Nuvigil Armodafinil Excessive Daytime Sleepiness Small US7132570 June 18, 2024 Teva Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Wakefulness-Promoting Agent
Macleods, Mankind, Cipla, Torrent
226 Oriahnn Elagolix/Estradiol/Norethi Heavy Mentrual Bleeding Small US7419983 July 6, 2024 Abbvie Inc Bayer Zydus, Abbott, Bharat Serum & Vaccine, Oral Gonadotropin-Releasing Hormone Receptor Antagonist /
ndrone Acetate US7056927 September 10, 2024 Emcure, Mylan, Serum Institute of India, Intas Estrogenic Steroid / Second-Generation Progestin
227 Xeglyze Abametapir Head Lice Infestation Small US9839631 July 16, 2024 Dr Reddy's Laboratories Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Novel Pediculicidal Metalloproteinase Inhibitor
Macleods, Mankind, Cipla, Torrent
228 Ninlaro Ixazomib Multiple Myeloma Small US8546608 August 12, 2024 Takeda Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Oral Proteasome Inhibitor
US8003819 August 6, 2027 Biotec, United Biotech, Intas Pharma, SR Pharma,
US8530694 August 6, 2027 Zydus Cadila
US7687662 August 6, 2027
US8859504 June 16, 2029
US7442830 November 20, 2029
229 Prezista Darunavir HIV/AIDS Small US8518987 August 16, 2024 Janssen Therapeutics Cipla, Emcure Pharma, Sun Pharma Oral Proteasome Inhibitor
US7700645 June 26, 2027
230 Xarelto Rivaroxaban Blood Clots Small US7157456 August 28, 2024 Janssen Therapeutics Dr Reddy's , Zydus Cadila, Cheminnova Oral Factor Xa Inhibitors
Lifesciences, Alniche Life Sciences, Cadila,
Macleods
231 MoviPrep POLYETHYLENE GLYCOL Use For Colonoscopy Bowel Preparation Small US7169381 September 1, 2024 Velinor AG Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Osmotic Laxative
3350 US7658914 September 1, 2024 Macleods, Mankind, Cipla, Torrent
232 Aldara Imiquimod Genital Warts, Superficial Basal Cell Carcinoma, Small US7696159 October 1, 2024 3M Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Immune Response Modifier
And Actinic Keratosis Macleods, Mankind, Cipla, Torrent
233 Brilinta Ticagrelor Stroke, Heart Attack Small USRE46276 October 30, 2024 Astrazeneca Cipla, Emcure, Natco, Intas, La Renon, Cadila, Oral Platelet Activation And Aggregation Inhibitor
Torrent, Sun pharma
234 Xiidra Lifitegrast Signs And Symptoms Of Dry Eyes Small US7745460 November 5, 2024 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Eye Drops Lymphocyte Function-Associated Antigen-1 Antagonist
US7928122 November 5, 2024 Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
US7314938 March 10, 2025
US8084047 May 17, 2026
US9890141 October 21, 2030
235 Nourianz Istradefylline Levodopa/Carbidopa In Adults With Parkinson’s Small US7541363 November 13, 2024 Kyowa Kirin Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Adenosine Receptor Antagonist
Disease Macleods, Mankind, Cipla, Torrent
236 Ponvory Ponesimod Multiple Sclerosis Small USRE43728 November 16, 2024 Janssen Pharmaceuticals Sun Pharma, Alkem, Micro Labs, Abbott, Intas, Oral Sphingosine L-Phosphate Receptor Modulator
US9062014 May 6, 2032 Lupin, Torrent, IPCA
237 Tukysa Tucatinib HER2-Positive Breast Cancer Small US7452895 November 16, 2024 Seagen Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitor
US8648087 April 12, 2031 Zydus, Glenmark, MSN, Dr Reddy, Natco
238 Asclera/Aethoxysklero Polidocanol Itching Caused By Eczema And Dry Skin Small US7731986 November 17, 2024 Methapharm Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical, Subcutaneous Sclerosing Agent
l/Varithena Macleods, Mankind, Cipla, Torrent Injection
239 Zepzelca Lurbinectedin Metastatic Small Cell Lung Cancer Small US7763615 December 13, 2024 PharmaMar, S.A. BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Injection Alkylating Agent
Zydus, Glenmark, MSN, Dr Reddy, Natco
240 Victrelis Boceprevir Hepatitis C -Genotype 1 Small USRE43298 December 22, 2024 Merck & Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Protease Inhibitor
Macleods, Mankind, Cipla, Torrent
241 Entresto Sacubitril; Valsartan Chronic Heart Failure Small US8404744 July 14, 2023 Novartis Dr Reddy's, Leeford, Alkem, Glenmark, Intas, Natco, Oral Neprilysin Inhibitor / Angiotensin II Receptor Blocker
US8796331 July 14, 2023 Pharmaceuticals Corp Macleods
US7468390 November 27, 2023
US8101659 January 15, 2025
242 Spinraza Nusinersen Sodiumz Spinal Muscular Atrophy Small US7101993 September 05, 2023 Biogen Idec Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intrathecal Antisense Oligonucleotide Inhibitor
US8110560 December 05, 2025 Macleods, Mankind, Cipla, Torrent
US7838657 July 11, 2027
US8361977 May 27, 2030
243 Tegsedi Inotersen Sodium Polyneuropathy Small US7015315 March 21, 2023 Akcea Therapeutics, Inc. Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Subcutaneous Ransthyretin-Directed Antisense Oligonucleotide
US7101993 September 05, 2023 Formulation
244 Dalvance Dalbavancin To Treat Severe Skin Infection Small US6900175 December 25, 2023 Allergan Sales LLC Cipla, Mylan, Zydus Cadila, Alkem, United Biotech Intravenous; Powder Lipoglycopeptide Antibiotic
Hydrochloride US7115564 November 14, 2023
US7119061 November 14, 2023
US8143212 November 14, 2023
245 Zykadia Ceritinib Lung Cancer Small US9416112 January 31, 2023 Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8188276 January 31, 2023 Pharmaceuticals Corp Zydus, Glenmark, MSN, Dr Reddy, Natco
US9018204 January 31, 2023
US8835430 January 31, 2023
US7893074 April 25, 2026
US9018204 November 20, 2027
US7964592 April 29, 2028
US8039479 June 29, 2030
US9309229 January 18, 2032
246 Promacta Eltrombopag Olamine Thrombocytopenia Small US7160870 May 20, 2023 Novartis Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Thrombopoietin Receptor Agonist
US7547719 January 13, 2026 Pharmaceuticals Corp Laboratories, Intas, Zydus Cadila, Alkem
247 Rubraca Rucaparib Camsylate BRAC-Mutated Ovarian Cancer Small US6495541 November 22, 2023 Clovis Oncology Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Anticancer Drug And Poly (ADP-Ribose) Polymerase (PARP)
US9045487 February 10, 2031 Zydus, Glenmark, MSN, Dr Reddy, Natco Inhibitor
US8754072 February 10, 2031
248 Mektovi Binimetinib Unresectable Or Metastatic Melanoma With A Small US7777050 March 13, 2023 Array Biopharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Kinase Inhibitors
BRAF V600 Mutation US8178693 March 13, 2023 Macleods, Mankind, Cipla, Torrent
US8193229 March 13, 2023
US8513293 March 13, 2023
US9562016 October 18, 2033
249 Zosyn Piperacillin Sodium, Bacterial Infection Small US6900184 April 14, 2023 Wyeth Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Penicillins And Beta-Lactamase Inhibitor
Tazobactam Sodium US7915229 April 14, 2023 LLC Macleods, Mankind, Cipla, Torrent
US8133883 April 14, 2023
250 Boniva Ibandronate Sodium Osteoporosis Small US7192938 May 06, 2023 Hoffmann La Roche Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Bisphosphonates
US7410957 May 06, 2023 Macleods, Mankind, Cipla, Torrent
US7718634 May 06, 2023
251 Votrient Pazopanib Hydrochloride Soft Tissue Sarcomas And Advanced Renal Cell Small US7105530 October 19, 2023 Novartis Natco, Bayer Zydus, Cipla, Arechar, Intas, Hetero Oral Kinase Inhibitors
Carcinoma Pharmaceuticals Corp
252 Tyzeka Telbivudine Chronic Hepatitis B Small US7858594 September 11, 2023 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral; Solution Nucleoside Analogue
US7589079 September 11, 2023 Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
253 Exforge Amlodipine Besylate; Hypertension Small US8101599 May 16, 2023 Novartis Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Oral Calcium Channel Blocker / Hiazide Diuretic /Angiotensin II
Hydrochlorothiazide; US8475839 May 16, 2023 Pharmaceuticals Corp Alembic Receptor Blocker
Valsartan
254 Ozurdex Dexamethasone Macular Edema Following Branch Retinal Vein Small US8034366 January 09, 2023 Allergan Sun Pharmaceuticals, Intas Pharmaceuticals, Zydus Implant; Intravitreal Corticosteroid
Occlusion (BRVO) Or Central Retinal Vein US8034370 January 09, 2023 Cadila
Occlusion (CRVO) US9192511 January 09, 2023
US10076526 January 09, 2023
US6899717 November 01, 2023
US8506987 January 09, 2023
US10702539 January 09, 2023
255 Feraheme Ferumoxytol Iron Deficiency Anemia Small US6599498 June 30, 2023 Amag Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Iron Replacement Product
Macleods, Mankind, Cipla, Torrent
256 Patanase Olopatadine Congestion, Sneezing, And Runny Nose Caused Small US7977376 February 02, 2023 Novartis Sun Pharma, Cipla, Lupin, Intas Spray, Metered; Nasal Mast Cell Stabilizer
Hydrochloride By Seasonal Allergies US8399508 September 17, 2022 Pharmaceuticals Corp
257 Mozobil Plerixafor Non-Hodgkin’s Lymphoma Or Multiple Small US6987102 July 22, 2023 Genzyme Corp Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Subcutanous Injection Hematopoeitic Stem Cell Mobilizer
Myeloma US7897590 July 22, 2023 Biotec, United Biotech, Intas Pharma, SR Pharma,
Zydus Cadila
258 Oraverse Phentolamine Mesylate Used For Reversal Of The Soft-Tissue Small US7229630 June 20, 2023 Septodont Holding SAS Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Nonselective Alpha-Adrenergic Antagonist
Anesthesia US7569230 October 17, 2023 Macleods, Mankind, Cipla, Torrent
259 Ryzolt Tramadol Hydrochloride Severe Pain Small US7988998 October 27, 2023 Purdue Pharma Products Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Tablet, Extended Opiate (Narcotic) Analgesic
LP Alembic Release; Oral
260 Toviaz Fesoterodine Overactive Bladder Syndrome Small US6858650 January 3, 2023 Pfizer Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Antimuscarinics
Macleods, Mankind, Cipla, Torrent
261 Ibrance Palbociclib HR-Positive And HER2-Negative Breast Cancer Small US6936612 January 16, 2023 pfizer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral CDK 4/6 Inhibitors
US7208489 January 16, 2023 Zydus, Glenmark, MSN, Dr Reddy, Natco
USRE47739 March 5, 2027
US10723730 February 8, 2034
262 Vizamyl Flutemetamol Used As A Diagnostic Tool For Alzheimer’s Small US7351401 January 24, 2023 GE Healthcare Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Radioactive Diagnostic Agent
Disease US8236282 May 21, 2024 Macleods, Mankind, Cipla, Torrent
US7270800 September 3, 2025
263 Janumet Sitagliptin/Metformin Type 2 Diabetes Small US6699871 January 26, 2023 Merck & Co Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Dipeptidyl Peptidase-4 (Dpp-4) Inhibitor / Biguanide
US7326708 May 24, 2027 Medipol, Zydus, Aristo and Quest Pharma
264 Lexapro Escitalopram Major Depressive Disorder Or Generalized Small US6916941 February 12, 2023 Lundbeck Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Selective Serotonin Reuptake Inhibitors
Anxiety Disorder India, Reliance Formulation
265 Victoza Liraglutide Type 2 Diabetes, Obesity, And Chronic Weight Large US6268343 February 22, 2023 Novo Nordisk Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Subcutaneous Incretin Mimetics
Management US8114833 February 13, 2026 Medipol, Zydus, Aristo and Quest Pharma
266 Fosamax Alendronic Acid Osteoporosis And Paget’s Disease Of Bone Small US7964212 March 6, 2023 Merck & Co Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Bisphosphonates
US7488496 August 11, 2023 Macleods, Mankind, Cipla, Torrent
267 Koselugo Selumetinib Neurofibromatosis Type I (NF-1) Small US8178693 March 13, 2023 Astrazeneca Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Oral Kinase Inhibitors
US7425637 April 11, 2024 Formulation
US9562017 December 12, 2026
US9156795 December 12, 2026
268 Akynzeo Netupitant / Palonosetron Acute And Delayed Chemotherapy-Induced Small US6297375 March 17, 2023 Helsinn Therapeutics Dr Reddy's, Glenmark, Torrent, Alkem Oral, Intravenous Neurokinin (NK1) Antagonists / 5-HT3 Receptor Antagonists
Nausea And Vomiting US10233154 September 25, 2035
US9951016 September 25, 2035
US10961195 September 25, 2035
US10676440 September 25, 2035
269 Kynamro Mipomersen Homozygous Familial Hypercholesterolemia Large US7015315 March 21, 2023 Genzyme Corp Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Oligonucleotide
US7511131 January 29, 2027 Macleods, Mankind, Cipla, Torrent Injection
270 Incruse Ellipta Umeclidinium Bromide Chronic Obstructive Pulmonary Disease Small USRE44874 March 23, 2023 GlaxoSmithKline Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Anticholinergics
US7498440 April 27, 2025 Macleods, Mankind, Cipla, Torrent
US7439393 May 21, 2025
US7488827 December 18, 2027
271 Xeljanz Tofacitinib Rheumatoid Arthritis, Psoriatic Arthritis, And Small US6965027 March 25, 2023 pfizer Intas, Cipla, Reliance , Lupin Oral Janus Kinase (Jak) Inhibitor
Ulcerative Colitis USRE41783 December 8, 2025
272 Vocabria Cabotegravir HIV/AIDS Small US8080551 April 11, 2023 Viiv Healthcare Cipla, Emcure Pharma, Sun Pharma Oral, Intramuscular HIV Integrase Inhibitor
US7125879 April 21, 2025
273 Dutrebis Lamivudine/Raltegravir HIV/AIDS Small US7820660 April 25, 2023 Merck sharp & Dohme Cipla, Emcure Pharma, Sun Pharma Oral Reverse-Transcriptase Inhibitor / Integrase Inhibitor
274 Fotivda Tivozanib Relapsed Or Refractory Advanced Renal Cell Small US6821987 April 26, 2023 AVEO Pharmaceuticals Natco, Bayer Zydus, Cipla, Arechar, Intas, Hetero Oral Kinase Inhibitor
Carcinoma (RCC) US7166722 November 16, 2023
275 Banzel Rufinamide Seizures Associated With Lennox-Gastaut Small US6740669 May 14, 2023 Eisai Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Anticonvulsants
Syndrome Macleods, Mankind, Cipla, Torrent
276 Nuzyra Maralixibat Chloride Community-Acquired Bacterial Pneumonia And Small US7553828 June 2, 2023 Paratek Pharmaceuticals Cipla, Mylan, Zydus Cadila, Alkem, United Biotech Oral, Intravenous Ileal Bile Acid Transporter Inhibitor
Acute Skin And Skin Structure Infections US7326696 September 24, 2023
US8383610 September 23, 2030
277 Halaven Eribulin Breast Cancer And Liposarcoma Small US6214865 July 20, 2023 Eisai Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Microtubule Dynamics Inhibitor
Zydus, Glenmark, MSN, Dr Reddy, Natco
278 Dexilant Dexlansoprazole Gastroesophageal Reflux Disease Small US6664276 July 30, 2023 Takeda Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Proton Pump Inhibitor
Macleods, Mankind, Cipla, Torrent
279 Onglyza Saxagliptin Type 2 Diabetes Small USRE44186 July 31, 2023 Astrazeneca Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Dipeptidyl Peptidase-4 Inhibitor
Medipol, Zydus, Aristo and Quest Pharma
280 Vyvanse Lisdexamfetamine Attention Deficit Hyperactivity Disorder Small US7659253 August 24, 2023 Shire (Takeda) IPCA, Sun Pharma, Intas, Taj Pharma Oral Central Nervous System Stimulant
US7655630 August 24, 2023
US7662787 August 24, 2023
281 Lumigan Bimatoprost High Pressure Inside The Eye Including Small US8038988 August 25, 2023 Allergan Zydus Cadila, Abbott, Sun Pharma, Zuventus, Eye Drops Prostaglandin Analog
Glaucoma US7851504 June 13, 2027 Macleods, Mankind, Cipla, Torrent
US8629185 July 15, 2031
282 Vibativ Telavancin MRSA Or Other Gram-Positive Infections Large US6635618 September 11, 2023 Theravance Biopharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Bactericidal Lipoglycopeptide
US7531623 January 1, 2027 Macleods, Mankind, Cipla, Torrent
283 Lupron Leuprorelin Prostate Cancer, Breast Cancer, Endometriosis, Large US8470359 October 15, 2023 Abbvie Inc BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Subcutaneous, Gonadotropin-Releasing Hormone Agonist
Uterine Fibroids Zydus, Glenmark, MSN, Dr Reddy, Natco Intramuscular
284 Feraheme Ferric Carboxymaltose Iron-Deficiency Anemia Large US11123321 October 20, 2023 AMAG Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Iron Replacement Product
US9376505 October 20, 2023 Macleods, Mankind, Cipla, Torrent
US7612109 February 5, 2024
285 Ozanex Ozenoxacin Impetigo Small US6335447 November 9, 2023 Cipher Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Topical Quinolone Antibiotic Drug
Macleods, Mankind, Cipla, Torrent
286 Stiolto® Respimat Tiotropium/Olodaterol Asthma Small US7491719 November 10, 2023 Boehringer Ingelheim Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Anticholinergics / Long-Acting Inhaled Beta-Agonists
US7056916 December 7, 2023 Macleods, Mankind, Cipla, Torrent
US7220742 May 12, 2025
US7727984 January 19, 2027
287 Otezla Apremilast Psoriasis And Psoriatic Arthritis Small US7893101 December 9, 2023 Amgen Intas, Cipla, Reliance , Lupin Oral Phosphodiesterase Inhibitor
US7427638 February 16, 2028
288 Rapivab Peramivir Influenza Small US6562861 December 16, 2023 BioCryst Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Guanidines
Pharmaceuticals Macleods, Mankind, Cipla, Torrent
289 VYNDAQEL Tafamidis/Meglumine Transthyretin Amyloidosis Small US8168663 December 19, 2023 Pfizer Abbott, Macleods, Intas, Lupin Oral Oral Transthyretin Stabilizer
US7214695 April 27, 2024
US9770441 August 31, 2035
290 Coreg Carvedilol High Blood Pressure, Congestive Heart Failure Small US7268156 December 27, 2023 GlaxoSmithKline Dr Reddy's, Leeford, Glenmark, Intas, Natco, Oral Beta-Blocker
(CHF), And Left Ventricular Dysfunction Macleods
291 Hetlioz Tasimelteon Non-24-Hour Sleep-Wake Disorder Small US5856529 December 9, 2022 Vanda Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Melatonin Receptor Agonist
US10829465 February 12, 2035 Macleods, Mankind, Cipla, Torrent
US10071977 February 12, 2035
292 Taflotan Tafluprost Open-Angle Glaucoma Small US5886035 December 18, 2022 Santen Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Eye Drops Prostaglandin Analog
Macleods, Mankind, Cipla, Torrent
293 Viibryd Vilazodone Major Depressive Disorder Small US7834020 December 5, 2022 Allergan Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Serotonin Modulator
US8673921 December 5, 2022 India, Reliance Formulation
294 Norvasc Amlodipine High Blood Pressure And Coronary Artery Small US6828339 November 20, 2022 Viatris Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Calcium Channel Blocker
Disease US6696481 April 15, 2023 Macleods, Mankind, Cipla, Torrent
US7846961 October 5, 2029
295 Ocaliva Obeticholic Acid Primary Biliary Cholangitis Small US7138390 November 16, 2022 Intercept Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Farnesoid X Receptor Agonist
USRE48286 February 21, 2027 Pharmaceuticals Macleods, Mankind, Cipla, Torrent
US10174073 June 17, 2033
296 Chantix Varenicline Smoking Cessation Small US6890927 November 6, 2022 Pfizer Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Nasal Spray Alpha-4 Beta-2 Neuronal Nicotinic Acetylcholine Receptor
US7265119 February 3, 2023 Formulation Partial Agonist
297 Neurontin Gabapentin Partial Seizures And Neuropathic Pain Small US8048917 November 6, 2022 Pfizer Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Oral Anticonvulsant
US6818787 April 6, 2025 Alembic
US8026279 November 10, 2026
298 Movantik Naloxegol Smoking Cessation Small US6890927 November 6, 2022 Pfizer Zydus Cadila, Abbott, Sun Pharma, Zuventus, Nasal Spray Peripherally Acting Mu-Opioid Receptor Antagonist
US7265119 February 3, 2023 Macleods, Mankind, Cipla, Torrent
299 Lupkynis Voclosporin Attack Of Lupus Nephritis Large US7332472 October 17, 2022 Aurinia Pharmaceutical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Cyclosporin A Analog
Macleods, Mankind, Cipla, Torrent
300 Myrbetriq Mirabegron Overactive Bladder Small US6346532 September 27, 2022 Astellas Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Beta-3 Adrenergic Agonist
US7342117 May 4, 2024 Macleods, Mankind, Cipla, Torrent
301 Abilify Aripiprazole Schizophrenia And Bipolar Disorder Small US8993761 September 5, 2022 Otsuka America Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Atypical Antipsychotic
US9359302 September 25, 2022 Phamaceuticals Co Ltd India, Reliance Formulation
US8642760 March 25, 2023
US8580796 March 25, 2023
US8399469 June 29, 2025
US10112903 June 24, 2030
US8431576 October 26, 2030
302 Bylvay Odevixibat Progressive Familial Intrahepatic Cholestasis Small US7132416 September 5, 2022 Albireo pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Ileal Bile Acid Transporter Inhibitor
US10975046 June 20, 2039 Macleods, Mankind, Cipla, Torrent
303 Nucynta Tapentadol Hydrochloride Schizophrenia And Bipolar Disorder Small US8993761 September 5, 2022 Otsuka America Sun Pharma, IPCA, Macleods, Torrents, MSN Oral Norepinephrine Reuptake Inhibitor
US9359302 September 25, 2022 Phamaceuticals Co Ltd Laboratories
US8642760 March 25, 2023
US8580796 March 25, 2023
US8399469 June 29, 2025
US10112903 June 24, 2030
US8431576 October 26, 2030
304 Addyi Flibanserin Pre-Menopausal Women With Hypoactive Small US7420057 August 1, 2022 Sprout Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Serotonin Receptor 1A Agonist/Serotonin Receptor 2A
Sexual Desire Disorder Macleods, Mankind, Cipla, Torrent Antagonist
305 Macrilen Macimorelin Growth Hormone Deficiency Small US6861409 August 1, 2022 Æterna Zentaris Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Peptidomimetic Growth Hormone Secretagogue
Macleods, Mankind, Cipla, Torrent
306 Slynd Drospirenone Birth Control Pills To Prevent Pregnancy Small US6441168 July 30, 2022 Exeltis USA, Inc Leeford, Organon (India), Serum Institute of India. Oral Progestin And Antiandrogen
Torrent, Mylan
307 Velcade Bortezomib Multiple Myeloma And Mantle Cell Lymphoma Small US6958319 July 25, 2022 Takeda Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Intravenous Proteasome Inhibitor
US6713446 July 25, 2022 Biotec, United Biotech, Intas Pharma, SR Pharma,
Zydus Cadila
308 Folotyn Pralatrexate Relapsed Or Refractory Peripheral T-Cell Small US6028071 July 16, 2022 Acrotech Biopharma Natco, Dr Reddy's, sun pharma, Cipla, Panacea Intravenous Folate Analogue Metabolic Inhibitor
Lymphoma Biotec, United Bioted, Intas Pharma, SR pharma,
Zydus Cadila
309 Lusedra Fospropofol Used In Diagnostic Or Therapeutic Procedures Small US6204257 July 1, 2022 Eisai Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Sedative-Hypnotic Agent
Such As Endoscopy Macleods, Mankind, Cipla, Torrent
310 Stivarga Regorafenib Metastatic Colorectal Cancer Small US7351834 June 28, 2022 Bayer BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
US8637553 February 16, 2031 Zydus, Glenmark, MSN, Dr Reddy, Natco
US9957232 July 9, 2032
311 Caprelsa Vandetanib Medullary Thyroid Cancer Small USRE42353 June 27, 2022 Genzyme Corp BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Kinase Inhibitors
Zydus, Glenmark, MSN, Dr Reddy, Natco
312 Pepaxto Melphalan Flufenamide Multiple Myeloma Small US6992207 June 25, 2022 Oncopeptides Natco, Dr Reddy, Sun Pharma, Cipla, Panacea Intravenous Alkylating Agent
Biotec, United Biotech, Intas Pharma, SR Pharma,
Zydus Cadila
313 Trulance Plecanatide Chronic Idiopathic Constipation And Irritable Large US7799897 June 9, 2022 Salix Pharmaceuticals Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Guanylate Cyclase-C Agonist
Bowel Syndrome US7041786 January 30, 2028 Macleods, Mankind, Cipla, Torrent
US10011637 June 5, 2034
314 Fycompa Perampanel Partial Seizures And Generalized Tonic-Clonic Small US6949571 June 8, 2022 Eisai Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Anticonvulsants
Seizures US8772497 July 1, 2026 Macleods, Mankind, Cipla, Torrent
315 Epidiolex Cannabidiol Seizures Associated With Lennox-Gastaut Small US10195159 May 7, 2022 Greenwich Biosciences Sun Pharma, Alkem, Micro Labs, Abbott, Intas, Oral, Inhalation Cannabinoid
Syndrome, Dravet Syndrome, Or Tuberous US11096905 October 14, 2035 Lupin, Torrent, IPCA
Sclerosis US11207292 April 26, 2039
316 Lynparza Olaparib BRCA-Mutated Advanced Ovarian Cancer Small US7151102 April 29, 2022 Astrazeneca BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Oral Polyadenosine 5'-Diphosphoribose Polymerase (PARP)
US7449464 October 11, 2024 Zydus, Glenmark, MSN, Dr Reddy, Natco Enzyme Inhibitor
US7981889 October 11, 2024
US8247416 September 24, 2028
317 Cerdelga Eliglustat Gaucher's Disease Small US6916802 April 29, 2022 Genzyme Corp Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Glucosylceramide Synthase Inhibitor
US7196205 June 26, 2026 Macleods, Mankind, Cipla, Torrent
318 Combigan Brimonidine / Timolol Glaucoma Small US7642258 April 19, 2022 Allergan Zydus Cadila, Abbott, Sun Pharma, Zuventus, Eye Drops Alpha Agonist / Beta Blocker
Macleods, Mankind, Cipla, Torrent
319 Teflaro Ceftaroline Fosamil Methicillin-Resistant Staphylococcus Aureus Small US6417175 April 11, 2022 Allergan Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Injection Antibacterial Agent
(MRSA) Macleods, Mankind, Cipla, Torrent
320 Lexiscan Regadenoson Myocardial Perfusion Imaging Small US6403567 April 10, 2022 Astellas Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Intravenous Injection A2a Receptor Agonist
US8106183 February 2, 2027 Macleods, Mankind, Cipla, Torrent
321 Leqvio Inclisiran Atherosclerotic Cardiovascular Disease And Large US9074213 March 9, 2022 Novartis Dr Reddy's, Leeford, Glenmark, Intas, Natco, Subcutaneous Small Interfering Rna (Sirna) Molecule
Heterozygous Familial Hypercholesterolemia US8232383 February 20, 2023 Pharmaceuticals Corp Macleods, Lupin Injection
US11078485 November 4, 2023
US10669544 March 8, 2024
US8809292 May 10, 2027
US9370582 December 4, 2028
US10806791 December 4, 2028
US10125369 August 18, 2034
322 Fusilev Levoleucovorin Toxicity Associated With Overdosage Of Folic Small US6500829 March 7, 2022 Spectrum Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Subcutaneous Folate Analog
Acid Antagonists Or Impaired Methotrexate Macleods, Mankind, Cipla, Torrent Injection
Elimination
323 Givlaari Givosiran Acute Hepatic Porphyria Large US8546143 January 9, 2022 Alnylam Pharmaceuticals Sun Pharma, IPCA, Macleods, Torrents, MSN Subcutaneous Sirna Drug
US9708610 January 1, 2024 Laboratories Injection
US10273477 March 8, 2024
US9708615 March 8, 2024
US9150605 August 28, 2025
US10131907 August 24, 2028
US8828956 December 4, 2028
US8106022 December 12, 2029
US10125364 March 15, 2033
US9133461 May 14, 2033
US10119143 October 3, 2034
US11028392 October 3, 2034
324 Vimpat Lacosamide Epilepsy And Partial-Onset Seizures Small USRE38551 March 17, 2022 UCB Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Oral Anticonvulsant
Macleods, Mankind, Cipla, Torrent
325 Pristiq Desvenlafaxine Major Depressive Disorder Small US6673838 March 01, 2022 Pfizer Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Oral Selective Serotonin And Norepinephrine Reuptake Inhibitor
US8269040 July 5, 2027 India, Reliance Formulation
326 Vimovo Esomeprazole/Naproxen Osteoarthritis, Rheumatoid Arthritis And Small US8557285 May 31, 2022 Horizon Medicines Llc Intas, Cipla, Reliance , Lupin Oral Proton Pump Inhibitor / Nonsteroidal Anti-Inflammatory
Ankylosing Spondylitis US8852636 May 31, 2022 Drug
US8858996 May 31, 2022
US9161920 May 31, 2022
US9198888 May 31, 2022
US9345695 May 31, 2022
US9707181 May 31, 2022
327 Januvia Sitagliptin Type 2 Diabetes Small US6699871 July 26, 2022 Merck sharp & Dohme Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Oral Dipeptidyl Peptidase-4 Inhibitor
US7125873 July 26, 2022 Medipol, Zydus, Aristo and Quest Pharma
328 Avastin Bevacizumab Metastatic Colorectal Cancer, Non-Small Cell Large US20150147317A1 January 2022 Genentech BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravenous Injection Antiangiogenic Agent
Lung Cancer (NSCLC), Glioblastoma (GBM), Zydus, Glenmark, MSN, Dr Reddy, Natco
Metastatic Kidney Cancer (Mrcc), Advanced
Cervical Cancer (CC), Ovarian Cancer(OC),
Hepatocellular Carcinoma (HCC)
329 Crestor Rosuvastatin Risk Of Stroke, Myocardial Infarction And Small US6316460B1 August 04, 2020 Astrazeneca Cipla, Emcure, Natco, Intas, La Renon, Cadila, Tablet HMG-CoA Reductase Inhibitors (Statins)
Arterial Revascularization Torrent, Sun pharma
As An Adjunct To Diet To LDL-C
As An Adjunct To Diet For The Treatment Of
Adults With:
Primary Dysbetalipoproteinemia.
Hypertriglyceridemia
330 Enbrel Etanercept Moderate To Severe Rheumatoid Arthritis Large US8163522B1 April 24, 2029 Amgen Intas, Cipla, Reliance, Lupin Subcutaneous Anti-TNFs Or TNF Blockers
Psoriatic Arthritis US8063182B1 November 22, 2028 Injection
Moderate To Severe Plaque Psoriasis NL300129I2 July 02, 2023
Ankylosing Spondylitis
Moderate To Severe Polyarticular Juvenile
Idiopathic Arthritis
331 Entyvio Vedolizumab Moderately To Severely Active Ulcerative Large WO2016086147A1 June 2023 Millenium Sun Pharmaceuticals, Intas Pharmaceuticals, Zydus Injection Integrin Receptor Antagonists
Colitis, Pharmaceuticals Cadila
Crohn’s Disease
332 Eylea Aflibercept Neovascular (Wet) Age-Related Macular Large US7070959B2 November 11, 2024 Regeneron and Bayer Zydus Cadila Intravitreal Injection Vascular Endothelial Growth Factor A (VEGF-A) Antagonists
Degeneration (AMD)
333 Lantus Insulin Glargine Paediatric Patients With Type 1 Diabetes Large US8048854B2 July 05, 2027 Sanofi Biocon Subcutaneous Long-Acting Insulin
Mellitus And Adults With Type 2 Diabetes EP2575865B1 May 27, 2031 Injection
Mellitus
334 Lucentis Ranibizumab Wet Age-Related Macular Degeneration (Wet Large DE202012011260U1 November 24, 2022 Genentech (Roche) Sun Pharmaceuticals, Intas Pharmaceuticals, Zydus Intravitreal Injection Vascular Endothelial Growth Factor A (Vegf-A) Antagonists
AMD), Diabetic Retinopathy And Diabetic Cadila
Macular Oedema (DR And DME), Myopic
Choroidal Neovascularisation (Mcnv), Macular
Oedema Following Retinal Vein Occlusion (RVO)
335 Opdivo Nivolumab Non-Small Cell Lung Cancer (NSCLC), Large US9393301B2 July 2, 2023 Bristol-Myers Squibb Co BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Intravitreal Injection Human Monoclonal Antibody
Melanoma, Advanced Kidney Cancer, Bladder US8168179B2 July 2, 2023 Zydus, Glenmark, MSN, Dr Reddy, Natco
Or Urinary Tract Cancer (Urothelial), Colorectal US9067999B1 July 2, 2023
Cancer (MSI-H/Dmmr), Classical Hodgkin US9073994B2 July 2, 2023
Lymphoma, Gastric Or Gastroesophageal US9439962B2 July 2, 2023
Junction Or Esophageal Cancers, Malignant US9402899B2 February 5, 2024
Pleural Mesothelioma U57595048B2 August 8, 2024
US8728474B2 August 8, 2024
336 OxyContin Oxycodone Moderate To Severe Pain Small US10696684 March 30, 2025 Purdue Pharma Products Taj Pharma Tablets Opiate (Narcotic) Analgesic
US10407434 March 30, 2025 LLP
US9522919 March 30, 2025
US9073933 March 30, 2025
337 Prolia/ Denosumab Giant Cell Tumor Of Bone, Hyperglycemia Of Large US8409578B2 June 25, 2022 Amgen Dr Reddy’s, Intas, Cipla, Alkem, Zydus, Bioelite Injection Monoclonal Antibodies
Xgeva Malignancy, Bone Metastases From Solid US8058418B2 November 30, 2023 Lifesciences, RPG Lifesciences, and Biorange
Tumour And Multiple Myeloma US7364736B2 February 19, 2025 Biologicals
338 Stelara Ustekinumab Moderate To Severe Active Crohn’s Disease, Large US7279157B2 January 13, 2022 Janssen Biotech Intas Pharmaceuticals Subcutaneous Human Igg1 Monoclonal Antibody
Ulcerative Colitis US9409984B2 February 27, 2022 Injection, Iv Infusion
US7166285B2 May 3, 2022
US8080247B2 August 2, 2022
US6902734B2 September 25, 2023
339 Symbicort/ Breztri Budesonide/Formoterol Asthma, Chronic Obstructive Pulmonary Small US20210069215A1 January 29, 2023 Astrazeneca Cipla, Lupin, Zydus Cadila, Macleods Pharma, Inhalation Aerosol Long-Acting Beta Agonists
Aerosphere Disease (COPD) Glenmark, Mankind, Intas, and Sun Pharma
340 Trulicity Dulaglutide Type-2 Diabetes And Cardiovascular Diseases Large US10369003132 October 15, 2024 Eli Lily and Co Lupin Injection Glucagon-Like Peptide-1 Agonists
US10376376B2 October 15, 2024
US10610371B2 October 15, 2024
US11083591B2 October 15, 2024
US905601892 October 15, 2024
US986771292 October 15, 2024
US10695187B2 June 28, 2025
US8273854B2 May 15, 2026
US10130493B2 July 17, 2026
US8535379B2 December 13, 2026
US11135072B2 April 11, 2027
341 Vistogard/ Xuriden Uridine Triacetate Hereditary Orotic Aciduria (Xuriden), Or For The Small US6258795 July 10, 2023 Wellstat Therapeutics Zydus Cadila, Abbott, Sun Pharma, Zuventus, Granules Pyrimidine Analog
Emergency Treatment Of Fluorouracil Or Macleods, Mankind, Cipla, Torrent
Capecitabine Overdose Or Toxicity (Vistogard)
342 Utibron Glycopyrrolate/ Long-Term Maintenance Treatment Of Air Flow Small US8479730 October 11, 2028 Novartis Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Powder Adrenergics With Anticholinergics
Indacaterol Maleate Blockage In Patients With Chronic Obstructive Pharmaceuticals Corp Macleods, Mankind, Cipla, Torrent
Pulmonary Disease, Including Chronic
Bronchitis And Emphysema. COPD Is A
Long-Term Lung Disease That Causes
Bronchospasm
343 Qvar Redihaler/Qnasl Beclomethasone Seasonal Or Perennial Allergic And Nonallergic Small US8132712 September 07, 2028 Norton Waterford Sun Pharma, Cipla, Lupin, Intas Inhalation Aerosol Corticosteroids
Dipropionate (Vasomotor) Rhinitis And Prevent The
Recurrence Of Nasal Polyps Following Surgical
Removal
344 Locametz Gallium Ga-68 Gozetotide Positron Emission Tomography (PET) Of Large US11369590 August 15, 2028 Aaa USA Novartis BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Injection Radiopharmaceutical Agent
Prostate- Specific Membrane Antigen (PSMA) Zydus, Glenmark, MSN, Dr Reddy, Natco
Positive Lesions In Men With Prostate Cancer
345 Epsolay Benzoyl Peroxide Inflammatory Lesions Of Rosacea Small US9868103 August 08, 2028 Galderm Labs Zydus Cadila, Abbott, Sun Pharma, Zuventus, Cream Topical Antibiotic
Macleods, Mankind, Cipla, Torrent
346 Intrarosa Prasterone Vulvar And Vaginal Atrophy In Postmenopausal Small US8629129 August 07, 2028 Millicent Abbott, Cadila Vaginal Inserts Steroids
Women Having Moderate To Severe Symptoms
347 Flonase Sensimist Fluticasone Furoate Maintenance Treatment Of Asthma In Adult Small US8347879 July 15, 2028 GlaxoSmithKline Sun Pharma, Cipla, Lupin, Intas Capsules Corticosteroid
Allergy Relief/ Arnuity And Pediatric Patients Aged 5 Years And Older.
Ellipta
348 Tekturna HCT Aliskiren Hemifumarate, Hypertension In Adults, To Lower Blood Small US8618172 July 13, 2028 Noden Pharma Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Tablets Direct Renin Inhibitor /Diuretics
Hydrochloroazide Pressure Alembic
349 Osphena Ospemifene Moderate To Severe Dyspareunia And Vgainal Small US8642079 July 09, 2028 Duchesnay Abbott, Cadila, Bayer Zydus, Bharat Serum & Tablets Selective Estrogen Receptor Modulator
Dryness, A Symptom Of Vulvar And Vaginal Vaccine, Emcure, Mylan, Serum Institute of India,
Atrophy, Due To Menopause Intas
350 Keytruda Pembrolizumab Melanoma, Lung Cancer, Head And Neck Large US94458307P June 13, 2028 Merck & Co BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Injection Monoclonal Antibody
Cancer, Hodgkin Lymphoma, Stomach Cancer, US8551967B2 September 5, 2031 Zydus, Glenmark, MSN, Dr Reddy, Natco
Cervical Cancer, Breast Cancer
351 Doral Quazepam Insomnia Characterized By Difficulty In Falling Small US7608616 June 03, 2028 Galt Pharms Zydus Cadila, Abbott, Sun Pharma, Zuventus, Tablets Benzodiazepine Derivative
Asleep, Frequent Nocturnal Awakenings, Macleods, Mankind, Cipla, Torrent
And/Or Early Morning Awakenings
352 Zuragard Isopropyl Alcohol Antiseptic Small US8703828 May 23, 2028 Zurex Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Solution Alcohol
Macleods, Mankind, Cipla, Torrent
353 Zetonna/Omnaris/ Ciclesonide Nasal Symptoms Associated With Seasonal And Small US8371292 February 01, 2028 Covis Sun Pharma, Cipla, Lupin, Intas Nasal Spray Corticosteroids
Alvesco Perennial Allergic Rhinitis
354 Implanon Etonogestrel Prevention Of Pregnancy Small US8722037 September 28, 2027 Organon Leeford, Organon (India), Serum Institute of India. Contraceptive Implant Long-Acting Synthetic Derived Progestin Contraceptive
Torrent, Mylan
355 Triferic Ferric Pyrophosphate Prevent Anemia In Patients With Chronic Large US7857977 September 08, 2027 Rockwell Medical Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Hematinic
Citrate Kidney Disease Who Are On Dialysis Macleods, Mankind, Cipla, Torrent
356 Lampit Nifurtimox Chagas Disease (American Trypanosomiasis) Small US8193196 September 02, 2027 Salix Pharmaceuticals Inc Zydus Cadila, Abbott, Sun Pharma, Zuventus, Tablets Antiprotozoals
Caused By Trypanosoma Cruzi Macleods, Mankind, Cipla, Torrent
357 Byfavo Remimazolam Besylate Procedural Sedation Small US10961250 July 10, 2027 Acacia Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Ultra-Short-Acting Benzodiazepine
Macleods, Mankind, Cipla, Torrent
358 Embeda Morphine Sulfate, Moderate To Severe Pain When Small US8877247 June 19, 2027 Alpharma Pharms Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Capsule Opiate (Narcotic) Analgesics/ Opiate Antagonists
Naltrexone Hydrocloride Around-The-Clock Pain Relief Is Needed For A Alembic, Intas, Sun Pharma
Long Time Period
359 Vitekta Elvitegravir HIV-1 Infection In Antiretroviral Small US7635704 April 26, 2027 Gilead Sciences Cipla, Emcure Pharma, Sun Pharma Tablets Integrase Inhibitor
Treatment-Experienced Adults
360 Lastacaft Alcaftadine Prevention Of Itching Associated With Allergic Small US10617695 March 19, 2027 Allergan Sun Pharma, Cipla, Lupin, Intas Ophthalamic Solution Antihistamines
Conjunctivitis
361 Tuzistra XR Chlorpheniramine Cough And Symptoms Associated With Upper Small US8790700 March 15, 2027 Tris Pharma Sun Pharma, Cipla, Lupin, Intas Oral Suspension Antihistamines / Opioid
Polistirex, Codeine Respiratory Allergies Or A Common Cold
Polistirex
362 Dyanavel XR Amphetamine Attention Deficit Hyperactivity Disorder (ADHD) Small US10086087 March 15, 2027 Tris Pharma IPCA, Sun Pharma, Intas, Taj Pharma Oral Suspension Central Nervous System Stimulants
US8337890 March 15, 2027
363 Advil Allergy Sinus Chlorpheniramine Runny Nose. Itchy, Watery Eyes. Small US7863287 February 28, 2027 GlaxoSmithKline Sun Pharma, Cipla, Lupin, Intas Tablets Antihistamine / Nonsteroidal Anti-Inflammatory Drug /
Maleate, Ibuprofen, Decongestant
Pseudoephedrine
Hydrochloride
364 Striverdi Respimat Olodaterol Hydrochloride Chronic Obstructive Pulmonary Disease (COPD), Small US7727984 January 19, 2027 Boehringer Ingelheim Zydus Cadila, Abbott, Sun Pharma, Zuventus, Inhalation Solution Long-Acting Beta-Agonist
Including Chronic Bronchitis And/Or Macleods, Mankind, Cipla, Torrent
Emphysema
365 Camcevi Kit Leuprolide Mesylate Hormone Dependent Advanced Prostate Small US10646572 January 16, 2027 Accord BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Injection GNRH And IS A GNRH Agonist
Cancer And For The Treatment Of High-Risk Zydus, Glenmark, MSN, Dr Reddy, Natco
Localised And Locally Advanced Hormone
Dependent Prostate Cancer
366 Epanova Omega 3 Carboxylic Acids To Reduce Triglyceride (TG) Levels In Adult Large US7960370 December 20, 2026 Astrazeneca Zydus Cadila, Abbott, Sun Pharma, Zuventus, Capsules Antilipemic
Patients With Severe (≥500 Mg/Dl) Macleods, Mankind, Cipla, Torrent
Hypertriglyceridemia
367 Axumin Fluciclovine F-18 Positron Emission Tomography (PET) In Men Small US10010632 November 28, 2026 Blue Earth BDR pharmaceuticals, Alkem, Sun Pharma, Hetero, Injection Cyclobutanes
With Suspected Prostate Cancer Recurrence Zydus, Glenmark, MSN, Dr Reddy, Natco
Based On Elevated Blood Prostate Specific
Antigen (PSA) Levels
368 Synribo Omacetaxine Chronic Or Accelerated Phase Chronic Myeloid Small US6987103 October 26, 2026 Teva Pharmaceuticals Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Protein Synthesis Inhibitor
Mepesuccinate Leukemia (CML) With Resistance And/Or Macleods, Mankind, Cipla, Torrent
Intolerance To Two Or More Tyrosine Kinase
Inhibitors (TKI)
369 Juvisync Simvastatin, Sitagliptin Type 2 Diabetes Mellitus Small US7326708 October 11, 2026 Merck sharp & Dohme Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Tablets Hmg-Coa Reductase Inhibitor/ Dipeptidyl Peptidase-4
Phosphate Medipol, Zydus, Aristo and Quest Pharma Inhibitor
370 Veregen Sinecatechins External Genital And Perianal Warts Small US5795911 October 02, 2026 Ani Pharms Zydus Cadila, Abbott, Sun Pharma, Zuventus, Ointment Keratolytic Agents
(Condylomata Acuminata) In Macleods, Mankind, Cipla, Torrent
Immunocompetent Patients 18 Years And Older
371 VALTURNA Aliskiren Hemifumarate, Hypertension Small US8168616 July 03, 2026 Novartis Emcure, Intas, Lupin, Torrent, Mankind, Glenmark, Tablets Renin Inhibitor / AT-1 Receptor Antagonist
Valsartan Alembic
372 Aplenzin Bupropion Hydrobromide Prevention Of Seasonal Major Depressive Small US7241805 June 27, 2026 Bausch Dr Reddy's, Sun Pharma, Intas Pharma, Lundbeck Tablets Atypical Antidepressant
Episodes In Patients With A Diagnosis Of India, Reliance Formulation
Seasonal Affective Disorder (SAD)
373 Supprelin LA Histrelin Acetate Central Precocious Puberty Small US8062652 June 16, 2026 Endo Pharma Bharat Serums & Vaccines, Sun Pharma, Intas, Subcutaneous Gonadotropin-Releasing Hormone Agonist
Emcure, Lupin Implants
374 Natazia Dienogest, Estradiol Pregnancy Prevention Small US8071577 May 13, 2026 Bayer Healthcare Leeford, Organon (India), Serum Institute of India. Tablets Progestogen / Steroid Ester
Valerate Torrent, Mylan
375 Bridion Sugammadex Sodium Reversal Of Neuromuscular Blockade Induced Large USRE44733 January 27, 2026 Organon Sub Merck Dr Reddy's, Sun Pharma, Intas Pharma, Reliance Injection Selective Relaxant Binding Agent
By Rocuronium Bromide And Vecuronium Formulation
Bromide
376 Otrexup Methotrexate Symptomatic Control Of Severe, Recalcitrant, Small US9629959 January 24, 2026 Otter Pharma Zydus Cadila, Abbott, Sun Pharma, Zuventus, Injection Antimetabolites
Disabling Psoriasis Macleods, Mankind, Cipla, Torrent
377 Recorlev Levoketoconazole Endogenous Hypercortisolemia In Adult Small US11478471 January 10, 2026 Strongbridge Zydus Cadila, Abbott, Sun Pharma, Zuventus, Tablets Cortisol Synthesis Inhibitor
Patients With Cushing's Syndrome Macleods, Mankind, Cipla, Torrent
378 Nevanac Nepafenac To Prevent And Treat The Pain And Small US8324281 December 02, 2025 Novartis Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Ophtalmic Solution Nonsteroidal Anti-Inflammatory Drugs
Inflammation That Can Occur After An Alembic
Operation To Remove A Cataract From The Eye
379 Kombiglyze XR Metformin Hydrochloride, Type 2 Diabetes Mellitus Small US9339472 July 13, 2025 Astrazeneca Sun Pharma, Torrent, Lupin, Glenmark, Dr Reddy’s, Tablets Biguanide / Dipeptidyl Peptidase-4 Inhibitor
Saxagliptin Hydrochloride Medipol, Zydus, Aristo and Quest Pharma
380 Troxyca ER Naltrexone Hydrochloride, Management Of Pain That Is Severe Enough Small US8685443 July 03, 2025 Pfizer Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Capsules Opiate (Narcotic) Analgesics/ Opiate (Narcotic) Analgesic
Oxycodone Hydrochloride Alembic, Intas, Sun Pharma
381 Edurant Rilpivirine Hydrochloride Short-Term Treatment Of HIV-1 Infection Small US7125879 April 21, 2025 Janssen Cipla, Emcure Pharma, Sun Pharma Tablets Non-Nucleoside Reverse Transcriptase Inhibitor
382 Forteo Teriparatide Postmenopausal Women Who Have Large US7517334 March 25, 2025 Eli Lilly Abbott, Macleods, Intas, Lupin Injection Recombinant Parathyroid Hormone
Osteoporosis
383 Juxtapid Lomitapide Mesylate An Adjunct To A Low-Fat Diet And Other Large US8618135 March 07, 2025 Amryt Zydus Cadila, Abbott, Sun Pharma, Zuventus, Capsules Microsomal Triglyceride Transfer Protein Inhibitor
Lipid-Lowering Treatments, Including LDL Macleods, Mankind, Cipla, Torrent
Apheresis Where Available, To Reduce
Low-Density Lipoprotein Cholesterol (LDL- C),
Total Cholesterol (TC), Apolipoprotein B (Apo
B), And Non-High-Density Lipoprotein
Cholesterol (Non-HDL-C)
384 Orilissa Elagolix Sodium Moderate To Severe Pain Caused By Small US7056927 September 10, 2024 Abbvie Inc Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Tablets Gonadotropin-Releasing Hormone Receptor Antagonist
Endometriosis Alembic
385 Contrave Bupropion Hydrochloride, Chronic Weight Management Small US11278544 April 11, 2024 Nalpropion Zydus Cadila, IPCA, Cipla, Dr Reddy's, Torrent, Tablets Norepinephrine/Dopamine-Reuptake Inhibitor , Opiate
Naltrexone Hydrochloride Alembic, Intas, Sun Pharma Antagonists
386 Thalomid Thalidomide Acute Treatment Of The Cutaneous Small US7230012 December 09, 2023 Celgene Cadila, Hetero, Intas, Alkem, United Biotech, Dr Capsules Interleukin (Il)-6 Production Inhibitor
Manifestations Of Moderate To Severe Reddy's, Sun Pharma, Getwell
Erythema Nodosum Leprosum