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Emerging Opportunities in Controlled-Release Generic Drugs

Published by: Espicom Healthcare Intelligence

Published: Aug. 21, 2009 - 128 Pages


Table of Contents


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)

Abstract

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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