Report: Emerging Opportunities in Controlled-Release Generic Drugs TOC

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
  - Generic Company Activity
- 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)

Emerging Opportunities in Controlled-Release Generic Drugs

Table of Contents

List of Tables

List of Figures