Countries covered: United States
This new report identifies 30 controlled-release drugs valued at US$15 billion, many of which will be losing patent protection in the medium term.
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- Foreword
- Executive Summary
- Overview
- Leading Generic Markets
- Controlled-Release Delivery Technology
- Delivery Platforms
- Controlled-Release Drugs
- FDA Approved Generics
- Cardiovascular
- Lescol XL (fluvastatin)
- Patents & Exclusivity
- Generic Company Activity
- Advicor (lovastatin+niacin)
- Patents
- Generic Company Activity
- Coreg CR (carvedilol phosphate)
- Patents & Exclusivity
- Generic Company Activity
- Cardizem LA (diltiazem)
- Patents
- Generic Company Activity
- Seloken/Toprol-XL (metoprolol succinate)
- Generics
- Orbus Pharma
- Adalat CC (nifedipine)
- Patents
- Generic Company Activity
- Tarka (trandolapril+verapamil)
- Patents
- Generic Company Activity
- Aggrenox (dypyridamole+acetylsalicylic acid)
- Patents
- Generic Company Activity
- CNS
- Concerta (methylphenidate)
- Patents
- Generic Company Activity
- Andrx (Watson)
- Impax
- Metadate CD / Equasym XL (methylphenidate)
- Patents
- Generic Company Activity
- Ritalin LA (methylphenidate)
- Patents
- Generic Company Activity
- Focalin XR (dexmethylphenidate)
- Patents
- Generic Company Activity
- Adderall XR (mixed amphetamine salts)
- Patents
- Generic Company Activity
- Barr & Teva
- Impax
- Actavis & Colony Pharmaceuticals
- Sandoz
- Andrx
- Carbatrol (carbamazepine)
- Patents
- Generic Company Activity
- Impax
- Nostrum
- CorePharma
- Teva
- Apotex
- Actavis
- Equetro (carbamazepine)
- Patents
- Generic Company Activity
- Tegretol XR (carbamazepine)
- Patents
- Generic Company Activity
- Seroquel XR (quetiapine)
- Patents & Exclusivity
- Generic Company Activity
- Amrix (cyclobenzaprine)
- Patents & Exclusivity
- Generic Company Activity
- Avinza (morphine)
- Patents
- Generic Company Activity
- OxyContin (oxycodone)
- Patents
- Generic Company Activity
- KV Pharmaceutical Company
- Mallinckrodt
- Impax Laboratories
- Teva Pharmaceutical Industries
- Endo Pharmaceuticals
- Opana ER (oxymorphone)
- Patents
- Generic Company Activity
- Impax
- Actavis
- Barr (Teva)
- Ultram ER (tramadol)
- Patents
- Generic Company Activity
- Cipher Pharmaceuticals
- Impax
- Effexor XR (venlafaxine)
- Patents
- Generic Company Activity
- Osmotica
- Lupin
- Cadila Healthcare
- Torrent Pharmaceuticals
- Sun Pharma
- Anchen Pharmaceuticals
- Mylan
- Apotex
- Biovail
- Impax
- Teva Pharmaceutical Industries
- Ambien CR (zolpidem tartrate)
- Patents
- Requip XL (ropinirole)
- Patents & Exclusivity
- Generic Company Activity
- Others
- Xatral/Uroxatral (alfuzosin)
- Patents
- Generic Company Activity
- Oxytrol (oxybutynin)
- Patents
- Generic Company Activity
- Detrol LA (tolterodine)
- Patents
- Generic Company Activity
- Sanctura XR (trospium chloride)
- Patents & Exclusivity
- Generic Company Activity
- Augmentin XR (amoxicillin+clavulanic acid)
- Patents
- Company Profiles
- Actavis
- CR/ER Products
- Patent Litigation & Agreements
- Oxymorphone litigation settled
- Acquisitions
- Actavis strengthens its position in India
- Actavis acquires Abrika
- Actavis acquires Alpharma’s Human Generics business
- Financials
- Handa Pharmaceuticals
- Seroquel XR Litigation
- Impax Laboratories
- Products
- R&D
- Patent Litigation & Agreements
- Suit filed as Impax submits ANDA for generic Amrix
- Lawsuit for infringement of Renvela patents
- Lawsuit for infringement of Doryx patent
- Agreement with Teva
- Financials
- KV Pharmaceutical
- CR/ER Products
- Patent Litigation Agreement
- KV settles oxycodone litigation with Purdue Pharma
- Financials
- Mallinckrodt
- CR/ER Products
- Mylan
- Products
- Patent Litigation
- Amrix
- Effexor XR
- Uroxatral
- Acquisitions
- Merck Generics Acquisition
- Matrix Laboratories Acquisition
- Financials
- Par Pharmaceutical
- CR/ER Products
- Patent Litigation
- Par and Reliant settle propafenone litigation
- Litigation relating to tramadol extended-release tablets
- Agreements
- AstraZeneca/Par enter agreement for generic version of Toprol-XL
- IntelliPharmaCeutics announces equity investment by Par Pharmaceutical
- Agreement with Abrika (Actavis)
- Financials
- Sun Pharma
- CR/ER Products
- Financials
- Taro Pharmaceutical Industries
- CR/ER Products
- Financials
- Teva Pharmaceutical Industries
- Products
- Patent Litigation & Agreements
- Teva Launches Generic Adderall XR
- Watson files patent lawsuit against Barr for Oxytrol
- Aggrenox Litigation Settlement with Boehringer Ingelheim
- Barr and Kos Settle Advicor Patent Litigation
- Amrix Patent Infringement Lawsuit
- Focalin XR Patent Litigation
- Ritalin LA Patent Litigation
- OxyContin Settlement
- Effexor XR Agreement
- Major Developments
- Teva acquires Barr
- Financials
- URL Pharma
- CR/ER Products
- Watson Pharmaceuticals
- CR/ER Products
- Patent Litigation
- Watson files ANDA for generic Sanctura XR; Allergan files lawsuit
- Watson files Mucinex D ANDA; Reckitt Benckiser files lawsuit
- Watson files ANDA for generic Enablex; Novartis files lawsuit
- Andrx gains methylphenidate court victory
- Acquisition
- Watson completes acquisition of Andrx
- Financials
- Zydus Cadila
- CR/ER Products
- Financials
- Major Developments
- Etna Biotech Acquisition
- Majority stake in Simayla Pharmaceuticals
- Laboratorios Combix Acquisition
- SOURCES
- Espicom Sources
- Others
- List of Tables
- Controlled-Release Drug Sales, 2008 (US$ Million)
- Controlled-Release Drugs by Therapy Area
- Controlled-Release Drugs by US Patent Expiry
- FDA ANDA Approval for Extended-Release Drugs, 2005-2009 (30th June)
- Lescol XL US Patents
- Advicor US Patents
- Coreg CR Sales, 2007-2008 (£ & US$ Million)
- Coreg CR US Patents
- Cardizem US Patents
- Seloken ZOK/Toprol-XL Sales, 2004-2008 (US$ Million)
- FDA ANDA Approvals for Metoprolol Succinate
- Adalat CC Sales, 2004-2008 (EUR & US$ Million)
- Adalat CC US Patents
- FDA ANDA Approvals for Nifedipine Extended-Release Tablets
- Tarka US Patents
- Aggrenox Sales, 2004-2008 (EUR & US$ Million)
- Aggrenox US Patents
- Concerta US Patents
- Metadate CD US Patents
- Ritalin LA US Patents
- Focalin XR US Patents
- Adderall XR US Patents
- Carbatrol US Patents
- Equetra US Patents
- Tegretol US Patent
- Seroquel XR US Patents
- Amrix US Patents
- Avinza US Patent
- OxyContin US Patents
- Opana ER US Patents
- Ultram ER US Patents
- Effexor XR US Patents
- Ambien CR US Patent
- Requip XL Sales, 2008 (£ & US$ Million)
- Requip XL US Patents
- Xatral/Uroxatral Sales, 2004-2008 (EUR & US$ Million)
- Uroxatral US Patents
- Tentative ANDA Approvals for 10mg Alfuzosin Hydrochloride ER Tablets
- Oxytrol US Patents
- Detrol LA US Patents
- Sanctura Sales, 2007-2008 (US$ Million)
- Sanctura XR US Patents
- Augmentin XR US Patents
- Actavis ANDA Approvals for CR/ER Products, 2006-2009
- Actavis Financial Results, 2003-2006 (EUR & US$ Million)
- Impax Laboratories ANDA Approvals for ER Products, 2004-2009
- Impax Financial Results, 2004-2008 (US$ Million)
- KV Pharmaceutical ANDA Approvals for CR/ER Products, 2004-2009
- KV Pharmaceutical Financial Results, 2004-2008 (US$ Million)
- Mallinckrodt ANDA Approvals for CR/ER Products, 2003-2009
- Mylan ANDA Approvals for CR/ER Products, 2002-2009
- Mylan Financial Results, 2004-2008 (US$ Million)
- Par Pharmaceutical Financial Results 2004-08 (US$ Million)
- Sun Pharma ANDA Approvals for CR/ER Products
- Sun Pharma: Financial Results, 2004-2008
- Taro ANDA Approvals for CR/ER Products
- Taro Pharmaceutical Industries restatements for 2004 and 2005 (US$000s)
- Teva ANDA Approvals for CR/ER Products, 2002-2009
- Barr ANDA Approvals for CR/ER Products, 2002-2009
- Teva Financial Results, 2004-2008 (US$ Millions)
- URL Pharma ANDA Approvals for ER Products, 2004-2009
- Watson ANDA Approvals for CR/ER Products, 2002-2009
- Andrx ANDA Approvals for CR/ER Products, 2002-2009
- Watson Financial Results, 2004-2008 (US$ Million)
- Zydus ANDA Approvals for CR/ER Products, 2005-2009
- Zydus Tentative ANDA Approval for CR/ER Product
- Zydus Cadila Financial Results, 2005-2009
- List of Figures
- Generic Pharmaceutical Expenditure, 2008 (US$ billions)
- Generic Pharmaceutical Expenditure per capita, 2008 (US$)
- Generic Pharmaceutical Expenditure as % of Total, 2008
- FDA ANDA Approvals by Therapy Area 2005-2009*
- FDA ANDA Approvals by Therapy Area 2005-2009* (%)
- FDA ANDA Approvals by Company, 2005-2009 (30th June)
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