Cardiovascular Generic Drugs: Prospects and Opportunities to 2012 : Market Research Report

Cardiovascular Generic Drugs: Prospects and Opportunities to 2012

Published by: Espicom Healthcare Intelligence

Published: Dec. 31, 2007 - 186 Pages

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); 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)

Abstract

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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Cardiovascular Generic Drugs: Prospects and Opportunities to 2012

Table of Contents

Abstract