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Profile on olmesartan

The document provides a comprehensive profile of olmesartan, an angiotensin II receptor antagonist used primarily for treating hypertension. It covers key aspects including pharmacokinetics, clinical uses, side effects, precautions, and drug interactions, as well as the demand-supply scenario in India and globally. Additionally, it details the patent situation and comparisons with other antihypertensive medications.

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1 PROFILE ON OLMESARTAN
2 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
3 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
4 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%
5 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.
Interactions Drug interactions may change how one’s medications work or increase your risk for serious side effects. Some products that may interact 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 Losartan1986 Valsartan, Candesartan Irbesartan 1990 Became the first successful Ang II antagonist drug Valsartan nonheterocyclic ARB Candesartan have stronger blood pressure lowering effects than and losartan. Irebesartan longer acting than valsartan & losartan 6 Drug interactions may change how one’s medications work or increase your risk for serious side effects. ct 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 Valsartan, Candesartan Irbesartan Telmisarta n 1991 Olmesartan1995 Valsartan – nonheterocyclic ARB Candesartan – Prodrug have stronger blood pressure lowering effects than and losartan. Irebesartan - longer acting than valsartan & losartan Telmisartan - longest elimination half-life of the ARBs or about 24 hours Olmesartan Newest ARB on the market, marketed in 2002 Drug interactions may change how one’s medications work or increase your risk for serious side effects. ct 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 Olmesartan Olmesartan - Newest ARB on the market, marketed in 2002
7 Comparative properties of ARB’s
8 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
9 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
10 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
11 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
12 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
13 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
14 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
15 Comparative pharmacokinetics of ARBs Characteristics and labeled indications ARBs There are currently seven ARBs in the market
16
17 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
18 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 export market 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 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
19 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
20 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
21 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
22 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 0 0.5 1 1.5 2 2.5 3 3.5 2011 2012 2012 2013 2014
23 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 Japan: (Olmetec, Rezaltas) US: Benicar, Benicar HCT, Azor, Tribenzor) Europe: Olmetec, Olmetec Plus, Sevikar, Sevikar HCT) ASCA Asia, South Central America 0 200 400 600 800 1000 1200 2009 2010 2011 2012 2013 2014 JPN (JPY Bn) EU (EUR Mn) ASCA etc (JPY Bn) US (USD Mn)
24 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 0 10 20 30 40 50 60 70 80 90 100 Daiichi Sankyo Teva Pharma Lek Pharma Ranbaxy Cipla Daewong Hanall Pharma
25 Yearwise patent Total number of patents filed 371 Regionwise patents Total number of patents filed 371 0 20 40 60 80 100 120 140 160 180 200 1995-1999 2000-2004 2005-2009 2010-2015 0 50 100 150 200 250 US Europe JPN WIPO Other global regions
26 Patent based on formulation / Process for API Total number of patents filed 371 66% 34% Preparation of API and intermediate and purification process Formulation of API

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Profile on olmesartan

  • 1.
  • 2.
    2 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
  • 3.
    3 4. WORLD DEMANDSUPPLY 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
  • 4.
    4 PRODUCT ANALYSIS Drug ClassAngiotensin 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%
  • 5.
    5 Clinical uses Used totreat 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.
  • 6.
    Interactions Drug interactions maychange how one’s medications work or increase your risk for serious side effects. Some products that may interact 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 Losartan1986 Valsartan, Candesartan Irbesartan 1990 Became the first successful Ang II antagonist drug Valsartan nonheterocyclic ARB Candesartan have stronger blood pressure lowering effects than and losartan. Irebesartan longer acting than valsartan & losartan 6 Drug interactions may change how one’s medications work or increase your risk for serious side effects. ct 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 Valsartan, Candesartan Irbesartan Telmisarta n 1991 Olmesartan1995 Valsartan – nonheterocyclic ARB Candesartan – Prodrug have stronger blood pressure lowering effects than and losartan. Irebesartan - longer acting than valsartan & losartan Telmisartan - longest elimination half-life of the ARBs or about 24 hours Olmesartan Newest ARB on the market, marketed in 2002 Drug interactions may change how one’s medications work or increase your risk for serious side effects. ct 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 Olmesartan Olmesartan - Newest ARB on the market, marketed in 2002
  • 7.
  • 8.
    8 ANTIHYPERTENSIVE MEDICATIONS List ofAntihypertensive 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
  • 9.
    9 Other antihypertensives Alpha-Blockers (Antihypertensive) Alphablockers, 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
  • 10.
    10 Perindopril Aceon Quinapril Accupril RamiprilAltace 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
  • 11.
    11 Calcium Channel Blockers Calciumchannel 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
  • 12.
    12 Diuretics, Potassium-Sparing Potassium-sparing diureticswork 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
  • 13.
    13 Vasodilators Vasodilators work bydilating 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
  • 14.
    14 Calcium channel blockersand 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
  • 15.
    15 Comparative pharmacokinetics ofARBs Characteristics and labeled indications ARBs There are currently seven ARBs in the market
  • 16.
  • 17.
    17 Mechanisms of antagonism Themechanisms 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
  • 18.
    18 INDIAN DEMAND SUPPLYSCENARIO 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 export market 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 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
  • 19.
    19 Indian formulators ofOlmesartan 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
  • 20.
    20 Intra Labs OLMEFAST-HOlmesartan 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
  • 21.
    21 Shrrishti HC OLEMAR-AMOlmesartan 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
  • 22.
    22 WORLD DEMAND SUPPLYSCENARIO 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 0 0.5 1 1.5 2 2.5 3 3.5 2011 2012 2012 2013 2014
  • 23.
    23 Business development activitiesby 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 Japan: (Olmetec, Rezaltas) US: Benicar, Benicar HCT, Azor, Tribenzor) Europe: Olmetec, Olmetec Plus, Sevikar, Sevikar HCT) ASCA Asia, South Central America 0 200 400 600 800 1000 1200 2009 2010 2011 2012 2013 2014 JPN (JPY Bn) EU (EUR Mn) ASCA etc (JPY Bn) US (USD Mn)
  • 24.
    24 PATENT SCENARIO Patent expiryon ‘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 0 10 20 30 40 50 60 70 80 90 100 Daiichi Sankyo Teva Pharma Lek Pharma Ranbaxy Cipla Daewong Hanall Pharma
  • 25.
    25 Yearwise patent Total numberof patents filed 371 Regionwise patents Total number of patents filed 371 0 20 40 60 80 100 120 140 160 180 200 1995-1999 2000-2004 2005-2009 2010-2015 0 50 100 150 200 250 US Europe JPN WIPO Other global regions
  • 26.
    26 Patent based onformulation / Process for API Total number of patents filed 371 66% 34% Preparation of API and intermediate and purification process Formulation of API