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Cardiovascular Generic Drugs: Prospects and Opportunities to 2012
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Description: |
With a number of first line therapies coming off-patent in the next 5 years the prospects for generic producers are good
Cardiovascular disease is a global problem. In the developed world, its prevalence is linked to our increasingly unhealthy lifestyle, with risk factors including lack of exercise, overweight and obesity, and smoking. It is also linked to diabetes, a condition affecting an increasing number of people worldwide which greatly increases the risk of developing heart disease. The main areas targeted by cardiovascular drugs are high blood pressure and elevated blood cholesterol levels.
While the cholesterol management market remains dominated by statins and fixed-dose combination drugs containing statins, the market for drugs to treat hypertension covers a number of classes, such as beta blockers, ACE inhibitors, angiotensin-II receptor antagonists, calcium channel blockers and alpha blockers. The number of drugs to achieve blockbuster status in this sector runs into double figures and recent patent expiries have been characterised by the launch of multiple generics in this highly competitive market. This trend is likely to continue with, for example, the generic launch of the major anti-hypertensive drug ramipril onto the US market which is anticipated in October 2008.
IN FOCUS...
Statins The most widely prescribed drugs for cholesterol management are HMG-CoA reductase inhibitors, or statins. In terms of revenue, Pfizer’s Lipitor (atorvastatin) is the largest selling drug of any kind worldwide. Lipitor accounts for around 40% of the market for cholesterol management drugs by value. Without a viable replacement in the pipeline, Pfizer is keen to hold onto its Lipitor revenue for as long as possible. Ranbaxy is equally keen to launch generic atorvastatin in key markets and continues its worldwide patent litigation battle with Pfizer. While Pfizer should be able to fend off generic competition in the US at least until its basic patent expires in March 2010, Lipitor has also been facing competition from multiple entries of generic simvastatin.
Anti-Hypertensives The global hypertension drugs market is currently valued at around US$38.5 billion. The range of drug classes available to treat high blood pressure contributes to the competitive nature of a market in which there were 13 blockbuster drugs in 2006, with combined sales of US$25.8 billion. While competition among the multinationals is significant in this lucrative segment, the marketplace for generics is equally competitive. Typically, an anti-hypertensive going off patent is highly contested with multiple generic market entrants.
Sales forecasts to 2012 for major products - Crestor - Lescol - Lipitor - Pravachol/Mevalotin - Zocor - Zetia - TriCor - Vytorin - Caduet - Aprovel/Avapro - Diovan/Co-Diovan - Cozaar/Hyzaar - Micardis - Atacand - Benicar/Olmetec - Norvasc - Adalat - Altace/Delix/Tritace - Accupril - Coreg - Seloken/Toprol-XL - Lotrel
Companies active in the cardiovascular market are reviewed with respect to
- Products - Financials - Significant developments |
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Contents: |
Foreword Executive Summary Cholesterol, Lipids and Triglycerides The cholesterol management drugs market Statins NICE Guidance on the use of statins Crestor (rosuvastatin) Patents Generic Company Activity Safety Issues Market Outlook Lescol (fluvastatin) Patents Generic Company Activity Orbus Pharma Market Outlook Lipitor (atorvastatin) Patents Ranbaxy’s global battle against Lipitor patents US Canada Austria Denmark Finland Ireland Norway Spain UK Australia Andean Pact countries Other generic company activity Morepen Laboratories Market Outlook Pravachol (pravastatin) Patents Generics Market Outlook Zocor (simvastatin) Generics Market Outlook Mevacor (lovastatin) Generics Altoprev (lovastatin XR) Other Antihyperlipidaemic Agents Zetia (ezetimibe) NICE Guidance on ezetimibe Patents Generic Company Activity Market Outlook TriCor (fenofibrate) Patents Generics Teva Lipofen (fenofibrate) Patents Market Outlook Niaspan (niacin) Patents & Litigation Market Outlook Combination Products Vytorin (ezetimibe+simvastatin) Patents Market Outlook Advicor (niacin+lovastatin) Patents & Litigation Caduet (amlodipine+atorvastatin) Patents Generic Company Activity Market Outlook The next five years Generics Potential new products New combinations ABT-335 AVE 5530 Anacetrapib AEGR-733 Hypertension The hypertension drugs market ARBs Aprovel (irbesartan) Patents Generic Company Activity Market Outlook Diovan/Co-Diovan (valsartan) Patents Generic Company Activity Market Outlook Cozaar/Hyzaar (losartan) Patents Generic Company Activity Market Outlook Micardis (telmisartan) Patents Generic Company Activity Market Outlook Atacand (candesartan cilexetil) Patents Generic Company Activity Market Outlook Benicar (olmesartan) Patents Generic Company Activity Market Outlook Dihydropyridine Calcium Channel Blockers Norvasc (amlodipine) Patents Generics Mylan Apotex Synthon Pharmaceuticals Market Outlook Adalat (nifedipine) Patents Generics Market Outlook Zanidip (lercanidipine) DynaCirc (isradipine) Patents Generics ACE Inhibitors Vasotec (enalapril) Generics Altace/Delix/Tritace (ramipril) Combinations Patents Generics Europe US Cobalt Pharmaceuticals Lupin Market Outlook Accupril (quinapril) Patents Generics Market Outlook Beta Blockers Coreg (carvedilol) Patents Generics Market Outlook Seloken/Toprol-XL (metoprolol succinate) Patents Generics Orbus Pharma Market Outlook Concor (bisoprolol) Generics Alpha Adreno-Receptor Antagonists Cardura (doxazosin) Generics Combination Products Lotrel (amlodipine+benazepril) Patents Generics Market Outlook Azor (amlodipine+olmesartan) Zanipress (lercanidipine+enalapril) New Drug Class – Oral Renin Inhibitors Rasilez/Tekturna (aliskiren) The next five years Generics Novel drugs in development Nebivolol Cleviprex (clevidipine) Darusentan Ilepatril Company Profiles Actavis Cholesterol and hypertension products Financials Major Developments Actavis acquires Abrika Actavis strengthens its position in India Actavis acquires Alpharma’s Human Generics business Apotex Cholesterol & hypertension products Patent litigation AstraZeneca files suit over Crestor Teva sues Apotex over carvedilol Apotex wins UK perindopril patent challenge Norvasc patent litigation Aurobindo Pharma Cholesterol and hypertension products Financials Major Developments AstraZeneca files action over Crestor Pharmacin acquisition Acquisition of US facility Milpharm: Aurobindo’s first acquisition in Europe Caraco Pharmaceutical Laboratories Hypertension products Financials Dr. Reddy’s Cholesterol and hypertension products Cardiovascular R&D Financials Major Developments Dr. Reddy’s and Torrent sign Russian lisinopril agreement Betapharm Acquisition Glenmark Pharmaceuticals Cholesterol and hypertension products Financials Major Developments Acquisition of majority shareholding in Medicamenta Impax Laboratories Cholesterol and hypertension products Financials InvaGen Pharmaceuticals Products Collaborative agreement with Glenmark Pharmaceuticals Lupin Cholesterol and hypertension products Financials Mylan Cholesterol and hypertension products Financials Major Developments Merck Generic Acquisition Matrix Laboratories Acquisition Crestor patent infringement litigation Par Pharmaceutical Cholesterol and hypertension products Financials Major Developments IntelliPharmaCeutics announces equity investment by Par Pharmaceutical Crestor patent infringement litigation AstraZeneca/Par enter agreement for generic version of Toprol-XL Reliant files patent infringement lawsuit against Par over Rythmol Ranbaxy Cholesterol and hypertension products Financials Major Developments Ranbaxy acquires Be-Tabs for US$71 million Ranbaxy acquires GSK's Mundogen generic business in Spain Ranbaxy acquires Terapia Ranbaxy’s global battle against Lipitor patents Roxane Laboratories Cholesterol and hypertension products Financials Sandoz Cholesterol & hypertension products Financials Major Developments Sandoz completes purchase of Hexal and Eon Labs Crestor patent infringement litigation Teva Pharmaceutical Industries Cholesterol & hypertension products Financials Watson Pharmaceuticals Cholesterol & hypertension products Financials Major Developments Sandoz' ANDA for generic Toprol-XL approved further to agreement with Watson Watson completes acquisition of Andrx Zydus Cadila Cholesterol & hypertension products Financials SOURCES Espicom Sources Others List of Tables US Patent Expiry for Cholesterol Management Drugs Sales of Branded Cholesterol Management Drugs, 2005-2006 (US$ Million) FDA ANDA Approvals of Cholesterol Management Drugs, 2001-2007 Crestor Sales, 2003-2006 (US$ Million) Crestor US Patents Lescol Sales, 2002-2006 (US$ Million) Lescol US Patents Lipitor Sales, 2002-2006 (US$ Million) Lipitor US Patents Pravachol Sales, 2002-2006 (US$ Million) Mevalotin Sales, 2003-2007 (¥ Million & US$ Million) Pravachol US Patents FDA ANDA Approvals for Pravastatin Zocor Sales, 2002-2006 (US$ Million) FDA ANDA Approvals for Simvastatin FDA ANDA Approvals for Lovastatin Zetia Sales, 2003-2006 (US$ Million) Zetia US Patents TriCor Sales, 2002-2006 (US$ Million) TriCor US Patents FDA ANDA Approvals for Fenofibrate Tentative ANDA Approvals for Fenofibrate Lipofen US Patent Niaspan Sales, 2002-2006 (US$ Million) Niaspan US Patents Vytorin Sales, 2004-2006 (US$ Million) Vytorin US Patents Advicor Sales, 2002-2006 (US$ Million) Advicor US Patents Caduet Sales, 2004-2006 (US$ Million) Caduet US Patents Paragraph IV Patent Certification for Amlodipine+Atorvastatin US Patent Expiry for Hypertension Drugs Sales of Branded Hypertension Drugs, 2005-2006 (US$ Million) FDA ANDA Approvals of Hypertension Drugs, 2005-2007 Aprovel/Avapro/Karvea Sales, 2002-2006 (Euros & US$ Million) Avapro/Avalide US Patents FDA Tentative ANDA Approvals for Irbesartan Diovan/Co-Diovan Sales, 2002-2006 (US$ Million) Diovan US Patents Cozaar/Hyzaar Sales, 2002-2006 (US$ Million) Cozaar/Hyzaar US Patents FDA Tentative ANDA Approvals for Losartan Micardis Sales, 2002-2006 (Euros & US$ Million) Micardis Sales in Japan, 2003-2007 (¥ & US$ Million) Micardis US Patents Atacand Sales, 2002-2006 (US$ Million) Blopress Sales, 2003-2007 (¥ Billion & US$ Million) Atacand/Atacand Plus US Patents Benicar/Olmetec Sales, 2004-2007 (¥ Billion & US$ Million) Benicar US Patents Norvasc Sales, 2002-2006 (US$ Million) Amlodin Sales, 2003-2007 (¥ Billion & US$ Million) UK Marketing Authorisations for Generic Amlodipine Besylate, 2006-07 FDA ANDA Approvals for Amlodipine Besylate Adalat Sales, 2002-2006 (Euros & US$ Million) Adalat US Patents FDA ANDA Approvals for Nifedipine, 2002-2007 Zanidip Sales, 2002-2006 (Euros & US$ Million) DynaCirc CR US Patents FDA ANDA Approvals for Isradipine Vasotec/Vaseretic Sales, 2002-2006 (US$ Million) FDA ANDA Approvals for Enalapril Altace/Delix/Tritace Sales, 2001-2006 (Euros & US$ Million) Altace US Patents FDA Tentative ANDA Approvals for Ramipril Accupril/Accuretic Sales, 2002-2006 (US$ Million) Accupril US Patents US FDA ANDA Approvals for Quinapril Coreg/Dilatrend Sales, 2002-2006 (£ & US$ Million) Coreg US Patents FDA ANDA Approvals for Carvedilol Seloken ZOK/Toprol-XL Sales, 2002-2006 (US$ Million) Toprol-XL US Patents FDA ANDA Approval for Metoprolol Succinate Concor Sales, 2002-2006 (EUR & US$ Million) FDA ANDA Approvals for Bisoprolol Cardura Sales, 2002-2006 (US$ Million) FDA ANDA Approvals for Doxazosin Lotrel Sales, 2002-2006 (US$ Million) Lotrel US Patents FDA ANDA Approval for Amlodipine+Benazepril FDA Tentative ANDA Approval for Amlodipine+Benazepril Leading Hypertension/Hypercholesterolaemia Products, 2006 Actavis: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Actavis Financial Results, 2003-2006 (EUR & US$ Million) Apotex: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2002-2007 Aurobindo: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2006-2007 Aurobindo Pharma: Financial Results, 2003-2007 Caraco: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2003-2007 Caraco Financial Results, 2003-2007 (US$ Million) Dr. Reddy’s Leading Cardiovascular Brands in India, 2005-2007 Dr Reddy's: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2001-2007 Dr Reddy's: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Dr. Reddy’s: Financial Summary, 2003-2007 Glenmark FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2007 Glenmark: Financial Results, 2003-2007 Impax: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2003-2007 Impax: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Impax Laboratories Financial Results, 2003 (US$ Million) InvaGen: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2005-2007 Lupin: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2002-2007 Lupin: Financial Results, 2003-2007 Mylan: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Genpharm FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Mylan: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Generics (UK) Ltd: UK Marketing Authorisation for Cholesterol & Hypertension Drugs, 2004-2007 Mylan Financial Results, 2003-2007 (US$ Million) Par Sales of Selected Cardiovascular Generics, 2004-06 (US$000s) Par Pharmaceutical: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2002-2007 Kali Laboratories: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2007 Par Pharmaceutical: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Par Pharmaceutical Financial Results 2003-06 (US$ Million) Ranbaxy: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Ranbaxy Financial Results, 2003-2006 Roxane: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2007 Roxane: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Roxane Net Sales, 2005-2006 (EUR & US$ Million) Sandoz: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Lek: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Sandoz: UK Marketing Authorisation for Cholesterol & Hypertension Drugs, 2004-2006 Sandoz Financial Results, 2004-2006 (US$ millions) Teva: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 IVAX: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2006 Teva: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Teva Financial Results, 2002-2006 (US$ millions) Watson: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2000-2007 Watson Financial Results, 2002-2006 (US$ Million) Zydus: FDA ANDA Approvals for Cholesterol & Hypertension Drugs, 2005-2007 Zydus: Tentative ANDA Approvals for Cholesterol & Hypertension Drugs Zydus Cadila: Consolidated Results, 2006-2007 Cadila Healthcare: Financial Results, 2003-2007 List of Figures Crestor Sales, 2003 – 2012 (US$ Million) Lescol Sales 2003-2012 (US$ Million) Lipitor Sales 2003-2012 (US$ Million) Pravachol Sales 2003-2012 (US$ Million) Mevalotin Sales 2003-2012 (US$ Million) Zocor Sales 2003-2012 (US$ Million) Zetia Sales 2003-2012 (US$ Million) TriCor Sales, 2003-2012 (US$ Million) Vytorin Sales, 2004-2012 (US$ Million) Caduet Sales 2004-2012 (US$ Million) Aprovel/Avapro Sales 2003-2012 (US$ Million) Diovan/Co-Diovan Sales 2003-2012 (US$ Million) Cozaar/Hyzaar Sales 2003-2012 (US$ Million) Micardis Sales 2003-2012 (US$ Million) Atacand Sales 2003-2012 (US$ Million) Benicar/Olmetec Sales 2003-2012 (US$ Million) Norvasc Sales 2003-2012 (US$ Million) Adalat Sales, 2003-2012 (US$ Million) Altace/Delix/Tritace Sales 2003-2012 (US$ Million) Accupril Sales 2003-2012 (US$ Million) Coreg Sales, 2003-2012 (US$ Million) Seloken/Toprol-XL Sales 2003-2012 (US$ Million) Lotrel Sales, 2003-2012 (US$ Million) |
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Summary: |
Cardiovascular Generic Drugs: Prospects & Opportunities to 2012 Providing…
Detailed assessment and forecast for leading products by value to 2012
An assessment of patent expiry and challenges
Competitive evaluation
Analysis of significant litigation
Patent expiry opportunities to 2015
All major drug classes Cholesterol, lipids and triglycerides Statins
Hypertension Dihydropyidine calcium channel blockers ACE inhibitors Beta blockers Alpha adreno-receptor antagonists This unbeatable information package comprises - Online access to the report - A pdf of the report - 12 months access to the generic cardiovascular news tracking service In 2007, sales of the leading branded drugs used to treat these conditions will exceed US$57 billion, with a number of these losing patent protection in the coming years. This important new strategic report evaluates this market sector and answers key questions such as:
11 hypertension drugs are due to lose patent protection over the next 5 years: what are they and when do the patents expire?
Ranbaxy is aggressively targeting Pfizer’s atorvastatin (Lipitor). What is the situation in 8 leading markets?
What will be the effect on the value of pravastatin of generic competition?
Does the trend towards authorised generics in the US indicate good commercial sense or capitulation by the patent holders?
What’s in the pipeline? New branded products that will compete with generics in the future.
How might Actavis’ meteoric growth change the generic corporate landscape?
What are Dr Reddy’s cardiovascular interest |
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Companies Mentioned |
- Actavis
- Apotex
- Aurobindo Pharma
- Caraco Pharmaceutical Labs
- Dr Reddy’s
- Glenmark
- Impax Laboratories
- InvaGen Pharmaceuticals
- Lupin
- Mylan
- Par Pharmaceutical
- Ranbaxy
- Roxane Laboratories
- Sandoz
- Teva
- Watson
- Zydus Cadila |
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