Injectable Generic Drugs: Prospects & Opportunities to 2010 (Revised Edition) : Market Research Report

Injectable Generic Drugs: Prospects & Opportunities to 2010 (Revised Edition)

Published by: Espicom Healthcare Intelligence

Published: Oct. 20, 2006 - 212 Pages

Foreword
Executive Summary
Market Overview: Injectable Drugs
Cancer: Cancer Therapy; Anti-Emetic
Cardiovascular Disorders - Thrombosis: Enoxaparin
Gastrointestinal: Esomeprazole; Lansoprazole; Pantoprazole
Anti-Infectives: Cephalosporins; Other Anti-Infectives
Biopharmaceuticals: Major Biotech Products; G-CSF; Recombinant Insulin; Interferon; Recombinant Somatropin (rhGH)
Company Profiles: Abraxis BioScience; Amphastar Pharmaceuticals; Apotex; Baxter Healthcare; Bedford Laboratories; Hospira; Mayne Pharma; Orchid Chemicals & Pharmaceuticals; Paddock Laboratories; Sandoz; Spectrum Pharmaceuticals; Sun Pharmaceutical Industries Ltd; Teva Pharmaceutical Industries; Wockhardt
SOURCES: Espicom Sources; Others
List of Tables: Leading Generic Markets, 2005-2010 (US$ Million); Population of Leading Generic Markets, 2003-2010 (000s); Per Capita Spending on Generic Pharmaceuticals, 2005-2010 (US$); US Patent Expiry for Major Injectable Drugs, 2004-2015; FDA ANDA Approvals for Injectable Drugs, 2005-2006; FDA Tentative ANDA Approvals for Injectable Drugs, 2004-2006; Deaths from Cancer of the Trachea, Bronchus & Lung in Leading Generic Markets; Deaths from Breast Cancer in Leading Generic Markets; Deaths from Colorectal Cancer in Leading Generic Markets; Deaths from Prostate Cancer in Leading Generic Markets; Cancer Deaths in the USA, 2000-2003; Estimated New Cases of Cancer in the USA, 2003-2006; US FDA Approved Generic Cancer Injectables; Paraplatin/Carboplat Sales, 2001-2005 (US$ Million); FDA ANDA Approvals for Carboplatin, 2004-2006; Taxotere Sales, 2001-2005 (Euros & US$ Million); Ellence Sales 2003-2005 (US$ Million); UK MRHA Marketing Authorisations for Epirubicin Injection; Gemzar Sales, 2001-2005 (US$ Million); Zoladex Sales 2001-2005 (US$ Million); Tentative ANDA Approvals for Granisetron Injection; Camptosar Sales 2003-2005 (US$ Million); FDA ANDA Approvals for Leuprolide; Sandostatin Sales, 2001-2005 (US$ Million); FDA ANDA Approvals for Octreotide Acetate, 2005-2006; Eloxatin Sales, 2001-2005 (Euros and US$ Million); Taxol Sales 2001-2005 (US$ Million); FDA ANDA Approvals for Paclitaxel, 2002-2006; Zometa Sales 2002-2005 (US$ Million); Zofran Sales, 2002-2005 (£ and US$ Million); UK MRHA Marketing Authorisations for Ondansetron Injection; Tentative ANDA Approvals for Ondansetron Injection; Prescriptions of Parenteral Low Molecular Weight Heparin in England, 2005; Lovenox/Clexane Sales, 2001-2005 (Euros & US$ Million); Arixtra Sales, 2004-2005 (£ & US$ Million); Nexium Sales, 2001-2005 (US$ Million); Lansoprazole Sales, 2002-2005 (US$ Million); Pantozol/Protonix Sales, 2001-2005 (Euros & US$ Million); FDA ANDA Approvals for Injectable Cephalosporins, 2000-2006; Rocephin Sales 2002-2005 (SFR Million & US$ Million); FDA ANDA Approvals for Ceftriaxone, 2003-2006; Maxipime Sales, 2001-2005 (US$ Million); Zosyn/Tazocin Sales, 2001-2005 (US$ Million); Diflucan Sales, 2001-2005 (US$ Million); FDA ANDA Approvals for Fluconazole Injection; Cipro Sales, 2001-2005 (Euros & US$ Million); ANDA Approvals for Generic Ciprofloxacin Injection; Sales of Levaquin/Floxin, 2002-2005 (US$ Million); Tentative ANDA Approvals for Generic Levofloxacin Injection; Proprietary EPO Sales, 2001-2005 (US$ Million); Proprietary G-CSF Sales, 2001-2005 (US$ Million); Proprietary Recombinant Insulin Sales, 2001-2005 (US$ Million); Proprietary Interferon Sales, 2001-2004 (US$ Million); APP ANDA Approvals, 2002-2006; APP Tentative ANDA Approvals; APP Financial Results, 2001-2005 (US$ Million); Amphastar ANDA Approvals, 2004; International Medication Systems ANDA Approvals, 2002-2005; Apotex ANDA Approvals for Injectables, 2002-2005; Baxter Healthcare ANDA Approvals for Injectables, 2002-2005; Baxter Healthcare Tentative ANDA Approvals for Injectables; ESI Lederle ANDA Approvals, 2002-2003; Baxter Financial Results, 2001-2005 (US$ Million); Bedford Laboratories ANDA Approvals, 2002-2006; Bedford Laboratories Tentative ANDA Approvals; Hospira ANDA Approvals, 2004-2006; Abbott ANDA Approvals for Injectables, 2002-2004; Hospira Tentative ANDA Approvals; Hospira Sales, 2001-2005 (US$ Million); Mayne Pharma ANDA Approvals, 2002-2006; Faulding Pharmaceutical ANDA Approvals, 2002-2003; Mayne Pharma Tentative ANDA Approvals; Mayne Pharma Sales, 2005-2006 (A$ Million & US$ Million); Orchid Healthcare ANDA Approvals for Injectables, 2005-2006; Orchid Financial Results, 2003-2006; Paddock Laboratories ANDA Approvals, 2003-2006; Sandoz ANDA Approvals for Injectables, 2005; Sabex ANDA Approvals, 2003-2005; Eon Labs ANDA Approval for Injectable, 2005; Biochemie ANDA Approval for Injectable, 2002; Sandoz financial results, 2003-2005 (US$ millions); Spectrum ANDA Approval for Injectable, 2005; Spectrum financial results, 2004-2005 (US$ 000s); Sun Pharma Tentative ANDA Approvals for Injectables; Sun Pharma Financial Results, 2004-2006 (Rs and US$ Million); Teva ANDA Approvals for Injectables, 2006; Teva Tentative ANDA Approvals for Injectables; Pharmachemie ANDA Approvals for Injectables, 2004; Sicor ANDA Approvals, 2002-2006; Sicor Tentative ANDA Approvals; Teva financial results, 2001-2005 (US$ millions); Wockhardt ANDA Approvals for Injectables; Wockhardt Financial Results, 2002-2005
List of Figures: Per Capita Spending on Generic Pharmaceuticals, 2005 (US$); Per Capita Spending on Generic Pharmaceuticals, 2010 (US$); Regional Cancer Deaths as a Percentage of Total Deaths; Deaths from Cancer of the Trachea, Bronchus & Lung in Leading Generic Markets; Deaths from Breast Cancer in Leading Generic Markets; Deaths from Colorectal Cancer in Leading Generic Markets; Deaths from Prostate Cancer in Leading Generic Markets; Carboplatin Market Forecast, 2003-2010 (US$ Million); Docetaxel Market Forecast, 2005-2010 (US$ Million); Epirubicin Market Forecast, 2005-2010 (US$ Million); Gemcitabine Market Forecast, 2005-2010 (US$ Million); Goserelin Market Forecast, 2005-2010 (US$ Million); Granisetron Market Forecast, 2005-2010 (US$ Million); Irinotecan Market Forecast, 2005-2010 (US$ Million); Leuprolide Market Forecast, 2005-2010 (US$ Million); Octreotide Acetate Market Forecast, 2005-2010 (US$ Million); Oxaliplatin Market Forecast, 2005-2010 (US$ Million); Paclitaxel Market Forecast, 2005-2010 (US$ Million); Zoledronic Acid Market Forecast, 2005-2010 (US$ Million); Ondansetron Injection Market Forecast, 2005-2010 (US$ Million); Enoxaparin Market Forecast, 2005-2010 (US$ Million); Fondaparinux Market Forecast, 2005-2010 (US$ Million); Esomeprazole IV Market Forecast, 2005-2010 (US$ Million); Lansoprazole IV Market Forecast, 2005-2010 (US$ Million); Pantoprazole IV Market Forecast, 2005-2010 (US$ Million); Ceftriaxone Market Forecast, 2005-2010 (US$ Million); Cefepime Market Forecast, 2005-2010 (US$ Million); Piperacillin+Tazobactum Market Forecast, 2005-2010 (US$ Million); Fluconazole Market Forecast, 2005-2010 (US$ Million); Ciprofloxacin Injection Market Forecast, 2005-2010 (US$ Million); Levofloxacin Injection Market Forecast, 2005-2010 (US$ Million); Epoetin Alpha Market Forecast, 2005-2010 (US$ Million); Darbepoetin Alpha Market Forecast, 2005-2010 (US$ Million); Epoetin Beta Market Forecast, 2005-2010 (US$ Million); Filgrastim/Pegfilgrastim Market Forecast, 2005-2010 (US$ Million); Lenograstim Market Forecast, 2005-2010 (US$ Million); Market Forecast for Insulin Analogues, 2005-2010 (US$ Million); Sales Forecast for Interferon, 2005-2010 (US$ Million); Sales Forecast for Somatropin, 2005-2010 (US$ Million)

Abstract

This report will provide industry planners, commercial developers and the investment community with a thorough review of the operating landscape for generic injectables. The report is packed with primary source information and market forecasts, and takes a balanced view of the players and products that will shape this high value market sector.

A number of high value drugs due to come off patent in the USA and Europe over the next few years are injectable.

These include drugs to treat cancer, venous thrombosis, gastrointestinal disorders and hospital acquired infections. Alongside these and falling in the same therapeutic categories are drugs that have come off patent in the USA since 2004 and have attracted generic competition, such as cancer therapies carboplatin and paclitaxel.

Generic companies are also beginning to take an interest in some of the older high value biopharmaceuticals, including erythropoietin, filgrastim, recombinant insulin, somatropin and interferon. If regulatory hurdles can be overcome, the potential rewards for generic companies in biosimilar products are huge. This sector is still very new; to date, only two companies have successfully followed the regulatory path in Europe and it is proving even more difficult to attain regulatory approval for biosimilars in the US.

The traditional view of generic drugs is that they offer a cheap alternative to their branded equivalents. Cost has been an important factor in their development, particularly for oral drugs that are relatively cheap to produce and can be introduced to that market at a fraction of the price of the original drug. Generic companies are, however, beginning to look for higher profit margins and injectable drugs potentially offer such opportunities.

Combined branded and generic sales of the non-biological injectables included in this study were around US$20.5 billion in 2005, of which around US$12.0 billion will lose patent protection in the US by 2010. The proprietary biopharmaceuticals that we believe are most likely to become available as generics once the legal hurdles to registration have been overcome, currently have combined sales in the region of US$27.2 billion.

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Injectable Generic Drugs: Prospects & Opportunities to 2010 (Revised Edition)

Table of Contents

Abstract