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Cardiovascular Generic Drugs: Prospects and Opportunities to 2012


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


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)


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


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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