PROFILE ON OLMESARTAN

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 PROFILE ON OLMESARTAN
1. PRODUCT ANALYSIS .............................................................................................................................. 4
Drug Class.................................................................................................................................................. 4
CAS Registry Number ................................................................................................................................ 4
Formula ..................................................................................................................................................... 4
Popular brand name ................................................................................................................................. 4
Pharmacokinetic data ............................................................................................................................... 4
Clinical uses ............................................................................................................................................... 5
Side effect ................................................................................................................................................. 5
Precautions ............................................................................................................................................... 5
Interactions ............................................................................................................................................... 6
Developments of ARB’s............................................................................................................................. 6
Comparative properties of ARB’s.............................................................................................................. 7

2. ANTIHYPERTENSIVE MEDICATIONS ...................................................................................................... 8

List of Antihypertensive Medications ....................................................................................................... 8
Angiotensin II Receptor Blockers .............................................................................................................. 8
Other antihypertensives ........................................................................................................................... 9
Recommended usual starting and maximum dosages and elimination half-lives ................................. 14
of angiotensin II type 1 receptor antagonists in the US ......................................................................... 14
Comparative pharmacokinetics of ARBs ................................................................................................. 15
Characteristics and labeled indications ARBs ......................................................................................... 15
Mechanisms of antagonism .................................................................................................................... 17
Key properties of ARB’s........................................................................................................................... 17

3. INDIAN DEMAND SUPPLY SCENARIO .................................................................................................. 18

Major Indian suppliers ............................................................................................................................ 18
Indian import demand ............................................................................................................................ 18
Indian export market .............................................................................................................................. 18
Indian formulators of Olmesartan .......................................................................................................... 19

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4. WORLD DEMAND SUPPLY SCENARIO ................................................................................................. 22
Major International Manufacturers ........................................................................................................ 22
World market for Angiotensin II Receptor Blockers .............................................................................. 22
World market for Benicar (Daiichi Sankyo)............................................................................................. 22
Sales of olmesartan ................................................................................................................................. 23

5. PATENT SCENARIO .............................................................................................................................. 24

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 PRODUCT ANALYSIS
Drug Class Angiotensin receptor blockers (ARBs)

CAS Registry Number 144689-63-4 Yes

Formula C29H30N6O6

Popular brand name

Japan Olmetec, Rezaltas

US Benicar, Benicar HCT, Azor, Tribenzor

Europe Olmetec, Olmetec Plus, Sevikar, Sevikar HCT

Olmesartan medoxomil is an angiotensin II receptor antagonist which has been used for the treatment
of high blood pressure.

It was developed by Sankyo in 1995, and is sold under the trade name Benicar and Olmecip (Cipla).

An ester prodrug, it is completely and rapidly hydrolyzed to the active acid form, olmesartan (RNH-6270)

The U.S. Food and Drug Administration (FDA) has determined that the benefits of Benicar continue to
outweigh its potential risks when used for the treatment of patients with high blood pressure according
to the drug label.

Pharmacokinetic data

Bioavailability 26%
Metabolism Hepatic (cannot be removed by hemodialysis)
Half-life 13 hours
Excretion Renal 40%, biliary 60%

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Clinical uses

Used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes,
heart attacks, and kidney problems.

Olmesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing
blood vessels so that blood can flow more easily.

This medication is also used to treat heart failure.

Unlike many angiotensin II receptor blockers, olmesartan is not recommended as a treatment to delay
or prevent microalbuminuria in diabetic patients.

Side effect

Dizziness or lightheadedness may occur as your body adjusts to the medication.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying
position.

It should be remembered that the doctor has prescribed this medication because he or she has judged
that the benefit is greater than the risk of side effects. Many people using this medication do not have
serious side effects.

Advised to tell the doctor right away if one has any serious side effects, including: fainting, symptoms of
a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), unusual decrease in
the amount of urine, severe/persistent diarrhea...

Precautions

Before taking olmesartan, it is advised to tell the doctor or pharmacist if he is allergic to it; or if he has
any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or
other problems.

Before using this medication, advised to tell the doctor or pharmacist his medical history, especially of:
kidney disease, liver disease, severe loss of body water and minerals (dehydration).

This drug may make him dizzy. Not advised to drive, use machinery, or do any activity that requires
alertness until he/ she is sure he/ she can perform such activities safely. Limit alcoholic beverages.

This medication may increase the potassium levels. Before using potassium supplements or salt
substitutes that contain potassium, advised to consult the doctor.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn
baby.

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Interactions

Drug interactions may change how one’s medications work or increase your risk for serious side effects.

Some products that may interactct with this drug include: aliskiren, lithium, drugs that may increase the
level of potassium in the blood (such as ACE inhibitors including benazepril/lisinopril, birth control pills
containing drospirenone).

Developments of ARB’s

Valsartan,
Telmisarta
1986 Losartan 1990 Candesartan 1991 1995 Olmesartan
n
Irbesartan

Became the first Valsartan – Telmisartan - Olmesartan -

successful Ang II nonheterocyclic ARB longest Newest ARB
antagonist drug Candesartan – Prodrug elimination on the
have stronger blood half-life of the market,
pressure lowering ARBs or about marketed in
effects than and 24 hours 2002
losartan. Irebesartan -
longer acting than
valsartan & losartan

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Comparative properties of ARB’s

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 ANTIHYPERTENSIVE MEDICATIONS
List of Antihypertensive Medications

• Alpha-Blockers, Antihypertensives
• Alpha2-Agonists, Central-Acting
• Aldosterone Antagonists, Selective
• Angiotensin II Receptor Blockers
• ACE (Angiotensin Converting Enzyme) Inhibitors
• Beta-blockers
• Calcium Channel Blockers
• Diuretics, Loop
• Diuretics, Potassium-Sparing
• Diuretics, Thiazide
• Peripheral Adrenergic Inhibitors
• Renin Inhibitors
• Vasodilators
• Antihypertensive Combinations

Angiotensin II Receptor Blockers

Angiotensin receptor blockers work by blocking the effects of hormone angiotensin II (type 1 receptor).
As a result, blood vessels dilate and blood pressure is reduced.

Generic Brand Name

Azilsartan Edarbi
Candesartan Atacand
Eprosartan Teveten
Irbesartan Avapro
Losartan Cozaar
Olmesartan Benicar
Telmisartan Micardis
Valsartan Diovan

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Other antihypertensives

Alpha-Blockers (Antihypertensive)

Alpha blockers, also called alpha-adrenergic antagonists, dilate blood vessels by blocking postsynaptic
alpha1-adrenergic receptors. Alpha blockers are generally not recommended as initial therapy.

Generic Brand Name

Doxazosin Cardura, Carduran
Prazosin Minipress, Minipress XL
Terazosin Hytrin

Alpha-2 Agonists, Central-Acting

Alpha-2 agonists work by stimulating alpha-2 receptors and decreasing sympathetic activity, which leads
to decreased blood pressure and heart rate.

Generic Brand Name

Generic Brand Name
Clonidine Catapres, Catapres TTS (patch), Dixarit, Duraclon,
Jenloga, Kapvay, Nexiclon XR
Guanabenz Wytensin
Guanfacine Intuniv, Tenex
Methyldopa Aldomet
Lofexidine Britlofex

Aldosterone Antagonists, Selective

Generic Brand Name

Eplerenone Inspra

ACE (Angiotensin Converting Enzyme) Inhibitors

ACE inhibitors remain the initial treatment of choice for hypertension. This class of drugs blocks the
conversion of angiotensin I to angiotensin II by inhibiting angiotensin-converting enzyme (ACE), thus
preventing constriction of blood vessels.

Generic Brand Name

Benazepril Lotensin
Captopril Capoten
Enalapril Vasotec
Fosinopril Monopril
Lisinopril Prinivil
Moexipril Univasc

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Perindopril Aceon
Quinapril Accupril
Ramipril Altace
Trandolapril Mavik

Beta-blockers

Beta-blockers produce antihypertensive action by reducing heart rate and cardiac output. Currently
beta-blockers are not recommended as first-line treatment due to the risk of stroke and new-onset of
type 2 diabetes when compared to other medications4

Generic Brand Name

Beta-blockers with alpha activity
Carvedilol Coreg, Coreg CR
Labetalol Trandate
Beta-blockers with intrinsic sympathomimetic activity
Acebutolol Sectral
Pindolol Visken
Penbutolol Levatol
Beta-1 cardioselective beta-blockers
Atenolol Tenormin
Betaxolol Kerlone
Bisoprolol Zebeta
Celiprolol Selectol
Metoprolol Lopressor, Toprol XL
Nebivolol Bystolic
Sotalol Betapace, Betapace AF, Sorine
Nonselective beta-blockers
Nadolol Corgard
Propranolol Inderal LA, InnoPran XL
Timolol Blocadren

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Calcium Channel Blockers

Calcium channel blockers decrease the entry of calcium into the cells of the heart and blood vessels. By
blocking the entry of calcium, this class of drugs reduces heart rate and contractility and dilates arteries.

Generic Brand Name

Amlodipine Norvasc, Lotrel
Bepridil Vascor
Clevidipine Cleviprex
Diltiazem Calan, Calan SR, Cardizem, Covera HS, Isoptin SR,
Verelan, Verelan PM
Felodipine Plendil
Lacidipine Caldine, Lacimen, Lacipil, Midotens, Motens
Lercanidipine Lercadip, Zanidip
Levamlodipine EsCordi Cor, Esam, Eslo, S-Amlip
Isradipine DynaCirc, DynaCirc CR
Nicardipine Cardene SR
Nifedipine Adalat, Nifediac, Nifedical, Procardia
Nimodipine Nimotop
Nisoldipine Sular
Verapamil Calan, Calan SR, Covera-HS, Isoptin SR, Verelan,
Verelan PM

Diuretics, Loop

Loop diuretics inhibit the sodium-potassium-chloride cotransporter in the thick ascending limb of the
loop of Henle. Loop diuretics promote increased water loss and sodium loss.

Generic Brand Name

Bumetanide Bumex
Ethacrynic acid Edecrin
Furosemide Lasix
Piretanide
Torsemide Demadex

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Diuretics, Potassium-Sparing

Potassium-sparing diuretics work by leaving more potassium in the blood, as a result more sodium and
water are excreted in the urine. Potassium-sparing diuretics are weak antihypertensives when used
alone.

Generic Brand Name

Amiloride Midamore
Spironolactone Aldactone
Triamterene Dyrenium

Diuretics, Thiazide

Thiazide diuretics reduce sodium absorption from the distal tubule segment of the kidney. Thiazide
diuretics are known to worsen insulin sensitivity and elevate serum total cholesterol levels4.

Generic Brand Name

Bendroflumethiazide Aprinox
Chlorothiazide Diuril
Chlorthalidone Hygroton
Indapamide Lozol
Hydrochlorothiazide Hydrodiuril
Methyclothiazide Enduron
Metolazone Zaroxolyn, Diulo, Mykrox

Peripheral Adrenergic Inhibitors

These medications are rarely used unless other medications don't help.

Generic Brand Name

Guanadrel Hylorel
Guanethidine Ismelin
Reserpine Serpasil

Renin Inhibitors

Renin inhibitors act by inhibiting the activity of renin, the enzyme responsible for angiotensin II levels.

Generic Brand Name

Aliskiren Tekturna

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Vasodilators

Vasodilators work by dilating arterioles. However, vasodilatation by itself causes increased sympathetic
outflow to the heart, leading to tachycardia and increased contraction.

Generic Brand Name

Diazoxide Proglycem
Hydralazine Apresoline, Dralzine
Minoxidil Loniten
Nitroprusside Nipride, Nitropress, Sodium Nitroprusside

Antihypertensive Combinations

Generic Brand Name

Alpha blockers and diuretics
Prazosin/Polythiazide Minizide
ACE inhibitors and Diuretics
Benazepril/HCTZ Lotensin HCT
Captopril/HCTZ Capozide
Enalapril/HCTZ Vaseretic
Fosinopril/HCTZ Monopril HCT
Lisinopril/HCTZ Prinzide, Zestoretic
Moexipril/HCTZ Uniretic
Quinapril/HCTZ Accuretic
Angiotensin ll Antagonists and Diuretics
Candesartan/HCTZ Atacand HCT
Eprosartan/HCTZ Teveten HCT
Irbesartan/HCTZ Avalide
Losartan/HCTZ Hyzaar
Olmesartan/HCTZ Benicar HCT
Telmisartan/HCTZ Micardis HCT
Valsartan/HCTZ Diovan HCT
Beta-blockers and Diuretics
Atenolol/Chlorthalidone Tenoretic
Bisoprolol/HCTZ Ziac
Metoprolol/HCTZ Lopressor HCT
Nadolol/Bendroflumethiazide Corzide
Propranolol/HCTZ Inderide
Timolol/HCTZ Timolide
Calcium channel blockers and ACE inhibitors
Amlodipine/Benzapril Lotrel
Diltiazem/Enalapril Teczem
Felodipine/Enalapril Lexxel
Lercanidipine/Enalapril Carmen ACE, Coripren
Verapamil/Trandolapril Tarka

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 Calcium channel blockers and Angiotensin II receptor antagonist
Amlodipine/Olmesartan Azor
Amlodipine/Olmesartan/HCTZ Tribenzor
Amlodipine/Telmisartan Twynsta
Amlodipine/Valsartan Exforge
Amlodipine/Valsartan/HCTZ Exforge HCT
Centrally acting drugs and Diuretics
Methyldopa/HCTZ Aldoril
Reserpine/Chlorothiazide Diupres
Reserpine/HCTZ Hydropres
Diuretic combinations
Amiloride/HCTZ Moduretic
Spironolactone/HCTZ Aldactone
Triamterene/HCTZ Dyazide, Maxzide
Clonidine/Chlorthalidone Combipres
Hydralazine/HCTZ Apresazide
Methyldopa/HCTZ Aldoril
Prazosin/Polythiazide Minizide
Other combinations
Amlodipine/Atorvastatin Caduet
Amlodipine/Aliskiren Tekamlo
Amlodipine/Aliskiren/HCTZ Amturnide
Aliskiren/HCTZ Tekturna HCT
Aliskiren/Valsartan Valturna

Recommended usual starting and maximum dosages and elimination half-lives

of angiotensin II type 1 receptor antagonists in the US

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Comparative pharmacokinetics of ARBs

Characteristics and labeled indications ARBs

There are currently seven ARBs in the market

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Mechanisms of antagonism

The mechanisms of antagonism also vary between the ARBs: some show insurmountable antagonism
(e.g. candesartan) and others show surmountable antagonism (e.g. losartan). Insurmountable
antagonism is characterised by long-lasting inhibition, slow dissociation, irreversible binding,
conformational changes and potentially internalisation, whereas surmountable antagonism is
characterised by short-lasting inhibition and fast, reversible binding.

Losartan only binds at two angiotensin II type 1 receptor (AT1) sites, compared to candesartan which
shows high binding affinity at four sites.2 It is suggested that the tight binding and slow dissociation of
candesartan from the AT1 receptor may account for the magnitude of the antihypertensive efficacy of
candesartan and for its long duration of action, inducing long-lasting suppression of the RAAS.

Key properties of ARB’s

Losartan: The only medicine in its class proven to lower the chance of stroke.
Only ARB that has been shown to reduce serum uric acid levels.
Only ARB approved by the FDA for treating nephropathy in patients withT2DM

Valsartan First ARB to receive approval in Heart Failure

Reverses ventricular remodeling and Improves survival outcome in HF

Telmisartan Highly selective inhibition of the angiotensin II receptor 1 (AT1)

Has the longest plasma half-life and largest volume of distribution of any ARB
Powerful 24-hour action, curbing the morning surge in blood pressure
compared to other leading ARB’s Has PPAR-gamma activity and hence improves Insulin
sensitivity

Olmesartan Significant mean double-digit blood pressure (BP) reductions vs baseline at

the starting dose

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 INDIAN DEMAND SUPPLY SCENARIO
Major Indian suppliers

• Abbott Healthcare Pvt. Ltd

• AstraZeneca
• Cadila Pharmaceuticals
• Cipla
• Dr. Reddys’s Laboratories
• Glenmark (Healtheon)
• GSK
• Lupin (Pinnacle)
• Matrix Laboratories
• Ranbaxy Laboratories
• Sun Pharmaceuticals
• Unimark Remedies
• Torrent Pharmaceuticals
• Alembic Limited

Indian import demand

Indian import of olmesartan API and its derivative products Neg

Indian import of formulated products containing olmesartan medoxomil

Import value Rs. 4.3 crores

Indian export market

Indian export of olmesartan API and its derivative products

Export quantity 600 kgs

Export value Rs. 3.6 crores

Indian export of formulated products containing olmesartan medoxomil

Export value Rs. 100 crores

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Indian formulators of Olmesartan

Name of the formulator Brand name Active Pharma Ingredients

Aamorb (Xeena) OUKAT Olmesartan
Aamorb (Xeena) OUKAT-H Olmesartan
AHPL WINBP – AM Olmesartan
AHPL WINBP- H Olmesartan
AHPL WINBP Olmesartan
AHPL WINBP TRIO Olmesartan
Ajanta ORTAN Olmesartan
AstraZeneca OLWAYS Olmesartan
AstraZeneca OLWAYS Olmesartan
Avyukt OLMISTAR Olmesartan
Avyukt OLMISTAR-H Olmesartan
Biocon OLMESAT Olmesartan
Biocon OLMESAT-AM Olmesartan
Biocon OLMESAT-ID Olmesartan
Cadila OLVAS Olmesartan
Cadila OLVAS Olmesartan
CE-Biotec OLMECARE Olmesartan
CE-Biotec OLMECARE-H Olmesartan
Cipla OLMECIP Olmesartan
Cipla OLMECIP-AM Olmesartan
Cipla OLMECIP-H Olmesartan
Cipla OLMECIP-TRIO Olmesartan
Zydus OLMY Olmesartan
Cubit Cucard) CULMI Olmesartan
Cubit (Cucard) ] CULMI-H Olmesartan
East West HYBREED-H Olmesartan
Emcure OLMEGARD Olmesartan
Emcure OLMEGARD-H Olmesartan
Eris OLMIN Olmesartan
Eris OLMIN-CH Olmesartan
Eris OLMIN-H Olmesartan
Fenestra OLMISTRA Olmesartan
Glenmark (Healtheon) OLMAX Olmesartan
Glenmark (Healtheon) OLMAX-AM Olmesartan
Glenmark (Healtheon) OLMAX-H Olmesartan
Glenmark (Healtheon) - OLMAX-M Olmesartan
GSK BENITEC Olmesartan
GSK BENITEC-H Olmesartan
Intas OLMARK Olmesartan
Intas OLMARK-A Olmesartan
Intas OLMARK-H Olmesartan
Intas ZOLTAB Olmesartan
Intra Labs OLMEFAST Olmesartan

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 Intra Labs OLMEFAST-H Olmesartan
Invision SOLMIREST Olmesartan
Invision SOLMIREST-H Olmesartan
Johnlee (Vista) OMTEN Olmesartan
Johnlee (Vista) ] OMTEN Olmesartan
Johnlee(Vista) OMTEN-AH Olmesartan
Johnlee(Vista) OMTEN-AM Olmesartan
Johnlee(Vista) OMTEN-H Olmesartan
Lifecare OLMELIFE Olmesartan
Lifecare OLMELIFE-H Olmesartan
Lupin (Pinnacle) PINOM Olmesartan
Lupin (Pinnacle) PINOM-A Olmesartan
Lupin (Pinnacle) PINOM-H Olmesartan
Lupin (Pinnacle) PINOM-M Olmesartan
Macleods AMLOVAS-OL Amlodipine
+Olmesartan
Macleods NEXOVAS-O Cilnidipine + Olmesartan
Medoxomil
Macleods OLMESAR Olmesartan
Macleods OLMESAR-A Amlodipine + Olmesartan
Macleods OLMESAR-AV Olmesartan
Macleods OLMESAR-CH Olmesartan
Macleods OLMESAR-H Olmesartan
Macleods OLMESAR-M Olmesartan
Macleods TRINEXOVAS Chlortalidone+Cilnidipine
Olmesartan
Macleods TRIOLMESAR Olmesartan
Mankind OLMETIME-AM Olmesartan
Mankind OLMETIME-AMH Olmesartan
Mankind OLMETIME-H Olmesartan
Merck OLMIGHTY Olmesartan
Merck OLMIGHTY-AM Olmesartan
Merck OLMIGHTY-H Olmesartan
Micro Carsyon OLMAT Olmesartan
Micro Carsyon OLMAT-AM Olmesartan
Micro Carsyon OLMAT-AMH Olmesartan
Micro Carsyon OLMAT-H Olmesartan
Olcare(Cardium) O-RELATE Olmesartan
Olcare(Cardium) O-RELATE-H Olmesartan
Pax Healthcare XOLMI H Olmesartan
Race Pharma ROLMEX-AM Olmesartan
Ranbaxy OLVANCE Olmesartan
Ranbaxy OLVANCE-H Olmesartan
Ranbaxy TRIOLVANCE Olmesartan
Ranbaxy (Cardiovasculars) OL-VAMLO - Olmesartan
Shrrishti HC OLEMAR Olmesartan

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 Shrrishti HC OLEMAR-AM Olmesartan
Sun OLMEZEST-AM Olmesartan
Sun OLMEZEST-BETA Olmesartan
Sun OLMEZEST-CH Olmesartan
Sun OLMEZEST-H Olmesartan
Sun TRIOLMEZEST Olmesartan
Sun (Azura) OLMEZEST Olmesartan
Torrent (Delta) OLMETOR-H Olmesartan
Torrent (Psycan) OLMETOR Olmesartan
Unichem OLSAR Olmesartan
Unichem OLSAR-A Olmesartan
Unichem OLSAR-AH Olmesartan
Unichem OLSAR-H Olmesartan
Unichem OLSAR-M TAB Olmesartan
Unichem OLSAR-M Olmesartan
USV OLMETRACK Olmesartan
USV OLMETRACK-AM Olmesartan
USV OLMETRACK-CT Olmesartan
USV OLMETRACK-H Olmesartan
Wonder (Xtra) OLMEDER Olmesartan
World Wide OLMIWALL Olmesartan
World Wide OLMIWALL-H Olmesartan
Zydus (CND) OLMY-A Amlodipine+ Olmesartan
Zydus (CND) OLMY-H Olmesartan
Zydus (CND) OLMY-R Ramipril+ Olmesartan

Indian market value for olmesartan API and its formulation

Indian market value for olmesartan API and its formulation

Around Rs. 1200 crores

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 WORLD DEMAND SUPPLY SCENARIO
Major International Manufacturers

• Daiichi Sankyo, Japan

• Beijing Winsunny Pharmaceutical Co., Ltd, China
• Shanghai Sankyo Pharmaceutical Co., Ltd, China
• Zhangjiang Hi-Tech Park Development Co., Ltd, China
• Shanghai Sine Promod Pharmaceutical Co., Ltd. , China
• Chemieliva Pharmaceutical Co., Ltd, China
• Finetech Industry Ltd, UK
• Second Pharma Co. China

World market for Angiotensin II Receptor Blockers

World market for Angiotensin II Receptor Blockers

(including ARB/ CCB and other ARB combination products) USD 7.5 billion

Share of ARBs in total hypertension drug market 53%

World market for Benicar (Daiichi Sankyo)

World sales in USD billion

3.5

2.5

1.5

0.5

0
2011 2012 2012 2013 2014

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Business development activities by Daiichi Sankyo

• Expand business in emerging countries through Ranbaxy and the Daiichi

• Sankyo business in ASCA*
• Maintain leadership in the US injectable iron market through launch of Injectafer
• Increase profitability of generic and vaccine businesses in Japan

Sales of olmesartan

1200

JPN (JPY Bn)

1000

800

US (USD Mn)
600

EU (EUR Mn)
400

200
ASCA etc (JPY Bn)
0
2009 2010 2011 2012 2013 2014

Japan: (Olmetec, Rezaltas)

US: Benicar, Benicar HCT, Azor, Tribenzor)
Europe: Olmetec, Olmetec Plus, Sevikar, Sevikar HCT)
ASCA Asia, South Central America

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 PATENT SCENARIO
Patent expiry on ‘Benicar’ –(Daiichi Sankyo) October 2016

Mylan Pharmaceuticals ($MYL) has won the right to sell the drug exclusively for the first 180 days after
the patent expires on the blockbuster.

Still, both companies may face competition sooner than they thought. In November 2012, Apotex
petitioned a U.S. court to rule that its Benicar generic wouldn't infringe patent rights. A finding of
noninfringement, Apotex said, would let it compete with Mylan sooner. But Apotex has yet to get its
own drug approved by the FDA.

Benicar's patent doesn't expire till 2016, but it's already feeling the pressure from generic drug makers
that think they can push their copies to market sooner.

Patent on olmesartan / olmesartan medoxomil

Companywise patents

Total number of patents filed 371

100

90

80

70

60

50

40

30

20

10

0
Daiichi Sankyo Teva Pharma Lek Pharma Ranbaxy Cipla Daewong Hanall Pharma

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Yearwise patent

Total number of patents filed 371

200

180

160

140

120

100

80

60

40

20

0
1995-1999 2000-2004 2005-2009 2010-2015

Regionwise patents

Total number of patents filed 371

250

200

150

100

50

0
US Europe JPN WIPO Other global regions

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Patent based on formulation / Process for API

Total number of patents filed 371

34%

Preparation of API and

intermediate and purification
process

Formulation of API

66%

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