Injectable Generic Drugs: Prospects & Opportunities to 2013 : Market Research Report

Injectable Generic Drugs: Prospects & Opportunities to 2013

Published by: Espicom Healthcare Intelligence

Published: Jul. 18, 2008 - 264 Pages

Foreword
Executive Summary
Overview
Leading Generic Markets: Injectables; Major Therapeutic Areas; Leading Companies and Competition
Cancer Injectables: Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; FDA Approved Generics
Hormonal Therapies: Faslodex (fulvestrant); Patents; Market Outlook; Zoladex (goserelin); Patents; Generic Company Activity; Market Outlook; Lupron Depot (leuprolide); Patents; Generic Company Activity; Market Outlook; Eligard (leuprolide); Patents
Chemotherapy: Taxotere (docetaxel); NICE Guidance; Patents; Generic Company Activity; Market Outlook; Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound); Patents; Litigation; Generic Company Activity; Market Outlook
Camptosar (irinotecan): NICE Guidance; Patents; Generic Company Activity; Market Outlook
Eloxatin (oxaliplatin): NICE Guidance; Patents; Generic Company Activity; Market Outlook; Gemzar (gemcitabine); Patents; Generic Company Activity; Market Outlook; Alimta (pemetrexed); NICE Guidance; Patents; Generic Company Activity; Market Outlook
Somatostatin Analogue: Sandostatin (octreotide acetate); Patents; Generic Company Activity; Market Outlook
Targeted Therapy: Rituxan/MabThera (rituximab); Biosimilar Activity; Market Outlook
Supportive Therapies: Zometa/Aclasta/Reclast (zoledronic acid); FDA Alert on Bisphosphonates; Patents; Market Outlook; Kytril (granisetron); Patents; Generic Company Activity; Market Outlook
G-CSF: Biosimilar Activity; CHMP issues positive opinion for biosimilar filgrastim; Apotex; Insmed; Abraxis/Biocon; EMEA Guidelines for Recombinant Granulocyte-Colony Stimulating Factor; Neupogen (filgrastim); Patents; Market Outlook; Neulasta (pegfilgrastim); Market Outlook; Neutrogin/Granocyte (lenograstim); Market Outlook; Leukine (sargramostim); Patents
Erythropoietin: Biosimilar Activity; EMEA recommendation of new warning for EPO in cancer patients; Epogen/Eprex (epoetin alpha); Patents; Market Outlook; Aranesp (darbepoetin alpha); Patents; Market Outlook; NeoRecormon/Epogin (epoetin beta); Market Outlook
Injectable Anti-infectives: FDA Approved Generics; Merrem (meropenem); Patents; Generic Company Activity; Market Outlook; Zosyn (piperacillin+tazobactam); Patents; Generic Company Activity; Market Outlook; Primaxin (imipenem+cilastatin sodium); Patents; Generic Company Activity; Market Outlook; Levaquin (levofloxacin); Patents; Generic Company Activity; Market Outlook; Cancidas (caspofungin acetate); Patents; Market Outlook
Interferon alpha: Biosimilar Activity; EMEA issues draft guidelines for biosimilar interferon alpha; Intron A (interferon alpha-2b); Market Outlook; PegIntron (peginterferon alpha-2b); Market Outlook; Pegasys (pegylated-40K interferon alpha-2a); Market Outlook
CNS Injectables: FDA Approved Generics; Tentative approval for sumatriptan
Multiple Sclerosis: Copaxone (glatiramer); Patents; Generic Company Activity; Market Outlook
Interferon beta: Biosimilar Activity; Avonex (interferon beta-1a); Market Outlook; Rebif (interferon beta-1a); Market Outlook; Betaferon/Betsaseron (interferon beta-1b); Market Outlook
Schizophrenia: Abilify (aripiprazole); Patents; Generic Company Activity; Market Outlook; Risperdal (risperidone); Patents; Generic Company Activity; Market Outlook; Zyprexa (olanzapine); Patents; Generic Company Activity; Market Outlook
Cardiovascular Injectables: FDA Approved Generics; Lovenox (enoxaparin); Patents; Generic Company Activity; Market Outlook; Arixtra (fondaparinux); Patents & Exclusivity; Generic Company Activity; Market Outlook; Integrilin (eptifibatide); Patents; Market Outlook; Angiomax (bivalrudin); Patents; Market Outlook
Endocrine Disorders
Recombinant Insulin & Insulin Analogues: Biosimilar Activity; Biocon; Bioton; EMEA Guidelines for Recombinant Human Insulin; Humulin (insulin human [rDNA origin]); Market Outlook; Humalog (insulin lispro); Patents; Market Outlook; Lantus (insulin glargine); Patents; Market Outlook; Novo Nordisk’s insulin analogues; Levemir (insulin detemir); Patents; NovoRapid/NovoLog (insulin aspart [rDNA origin]); Patents; NovoMix/NovoLog Mix; Patents; Market Outlook
Recombinant Human Growth Hormone: Biosimilar Activity; Sandoz; BioPartners; Cangene; Teva; EMEA Guidelines for Somatropin; Genotropin; Patents; Market Outlook; Humatrope; Market Outlook; Norditropin; Patents; Market Outlook; Nutropin; Patents; Market Outlook; Saizen/Serostim; Market Outlook
Company Profiles
Amphastar Pharmaceuticals: Injectable Products; Proposed generic enoxaparin
Apotex: Injectable Products; Financials; Relevant Agreements; Apotex to develop biosimilar G-CSF with IBP; Orchid Chemicals & Pharmaceuticals; BioGeneriX
APP Pharmaceuticals: Products; Financials; Major Developments; Abraxis Bioscience Demerger; Abraxis acquisition of AstraZeneca’s US anaesthetic and analgesic injectable products
Baxter: Generic Injectable Products; Voluntary heparin recall; Financials; Major Developments; Acquisition of ESI Lederle
Bedford Laboratories: Products; Sales; Agreements; Novo Nordisk
Hikma Pharmaceuticals: Injectable Products; Financials; Major Developments; Acquisition of Egypt’s Alkan Pharma; Acquisition of Thymoorgan; Acquisition of Ribosepharm
Hospira: Products; Financials; Major Developments; Mayne Pharma acquisition; Hikma Pharmaceuticals agreement
Orchid Chemicals & Pharmaceuticals: Products; Financials; Major Developments; Orchid forms Japanese subsidiary; Relevant Agreements; Strategic alliance with Ranbaxy; Actavis agreement; Apotex agreement; Acquisitions & Joint Ventures; Bexel Pharmaceuticals Inc.; Biotechnological Chemical Development Ltd.; Mano Pharmaceuticals & Sali Healthcare; NCPC Orchid Pharmaceuticals Ltd.
Paddock Laboratories: Products
PharmaForce: Products
Sagent Pharmaceuticals: Products; Major Developments; Agreement with Astral; Agreement with Strides Arcolab; Co-promotion agreement with Anesiva
Sandoz: Products; Financials; Major Developments; Sandoz receives regulatory guidance on enoxaparin ANDA; Collaboration with Momenta Pharmaceuticals
Sun Pharma: Products; Financials; Major Developments; Able Laboratories acquisition; Caraco equity stake
Teva Pharmaceutical Industries: Products; Financials; Major Developments; Relevant Patent Litigation; Adenoscan; Gemzar; Lovenox; IVAX acquisition; Sicor acquisition
Wockhardt: Injectable Products; Financials; Major Developments; Morton Grove acquisition; Wockhardt acquires France’s Negma Laboratories
Appendix I: FDA ANDA Approvals
Appendix II: UK Injectable Generic Approvals
SOURCES
Espicom Sources
Others
List of Tables: US Patent Expiry for Major Injectable Drugs; Injectables with Eight or More Generic Competitors in the US Market; FDA Approved Generic Cancer Injectables, 2003-2008; Faslodex Sales 2003-2007 (US$ Million); Faslodex US Patents; Zoladex Sales, 2003-2007 (US$ Million); Zoladex US Patents; Lupron Depot/Leuplin Sales, 2003-2007E (US$ Million); Lupron Depot US Patents; FDA ANDA Approvals for Leuprolide; Eligard US Patents; Taxotere Sales, 2003-2007 (EUR & US$ Million); Taxotere US Patents; Abraxane Sales, 2005-2007 (US$ Million); Abraxane US Patents; FDA ANDA Approvals for Paclitaxel, 2002-2008; Camptosar Sales, 2003-2007 (US$ Million); Camptosar US Patents; FDA ANDA Approvals for Irinotecan; Eloxatin Sales, 2003-2007 (EUR & US$ Million); Eloxatin US Patents; Gemzar Sales, 2003-2007 (US$ Million); Gemzar US Patents; Tentative ANDA Approvals for Gemcitabine; Alimta Sales, 2004A-2013E (US$ Million); Alimta US Patents; Sandostatin Sales, 2003-2007 (US$ Million); Sandostatin US Patents; FDA ANDA Approvals for Octreotide Acetate; Sandostatin Sales, 2003A-2013E (US$ Million); Rituxan/MabThera Sales, 2003-2007 (US$ Million); Zometa Sales, 2003-2007 (US$ Million); Zometa US Patents; Kytril Sales, 2003-2007 (SFr & US$ Million); Kytril US Patents; FDA ANDA Approvals for Granisetron Injection; Neupogen Sales, 2003-2007 (US$ Million; Neulasta Sales, 2003-2007 (US$ Million); Neutrogin/Granocyte Sales, 2003-2007 (¥ Billion & US$ Million); Epogen/Eprex Sales, 2003-2007 (US$ Million); Amgen’s Erythropoietin US Patents; Aranesp Sales, 2003-2007 (US$ Million); NeoRecormon/Epogin Sales, 2003-2007 (¥ Billion & US$ Million); FDA Approved Generic Anti-infective Injectables, 2003-2008; Merrem Sales, 2003-2007 (US$ Million); Meropen Sales, 2003-2007 (¥ Billion & US$ Million); Zosyn Sales, 2003-2007 (US$ Million); Primaxin Sales, 2003-2007 (US$ Million); Levaquin/Floxin Sales, 2003-2007 US$ Million); Cravit Sales, 2004-2008 (¥ Million & US$ Million); Levaquin US Patent; Tentative ANDA Approvals for Levofloxacin Injection; Cancidas Sales, 2003-2007 (US$ Million); Cancidas US Patents; Intron A Sales, 2003-2007 (US$ Million); PegIntron Sales, 2003-2007 (US$ Million); Pegasys Sales, 2003-2007 (SFr & US$ Million); FDA Approved Generic CNS Injectables, 2003-2008; Tentative ANDA Approvals for Sumatriptan Injection; FDA ANDA Approvals for Mitoxantrone; Copaxone Sales, 2003-2007 (EUR & US$ Million); Copaxone US Patents; Avonex Sales, 2003-2007 (US$ Million); Rebif Sales, 2003-2007 (EUR & US$ Million); Betaferon/Betaseron Sales, 2003-2007 (EUR & US$ Million); Abilify Sales, 2003-2007 (US$ Million); Abilify Injection US Patents; Risperdal Sales, 2003-2007 (US$ Million); Risperdal Consta US Patents; Zyprexa Sales, 2003-2007 (US$ Million); Zyprexa Injection US Patent; FDA Approved Generic Cardiovascular Injectables, 2003-2008; Lovenox/Clexane Sales, 2003-2007 (EUR & US$ Million); Lovenox US Patents; Arixtra Sales, 2004-2007 (£ & US$ Million); Integrilin Sales, 2003-2007 (US$ Million); Integrilin US Patents; Angiomax Sales, 2003-2007 (US$ Million); Angiomax US Patent; Humulin Sales, 2003-2007 (US$ Million); Humalog Sales, 2003-2007 (US$ Million); Humalog US Patents; Lantus Sales, 2003-2007 (EUR & US$ Million); Lantus US Patents; Novo Nordisk Insulin Analogue Sales, 2003-2007 (DKr & US$ Million); Levemir US Patents; NovoLog US Patents; NovoMix 70/30 US Patents; Genotropin Sales, 2003-2007 (US$ Million); Genotropin US Patents; Humatrope Sales, 2003-2007 (US$ Million); Novo Nordisk Growth Hormone Therapy Sales, 2003-2007 (DKr & US$ Million); Norditropin US Patents; Nutropin/Protropin Sales, 2003-2007 (SFr & US$ Million); Nutropin US Patent; Saizen & Serostim Sales, 2003-2007 (EUR & US$ Million); Amphastar ANDA Approval; International Medication Systems ANDA Approvals, 2002-2005; Apotex ANDA Approvals for Injectables, 2002-2008; Cangene Financial Results, 2003-2007 (C$ Million); APP ANDA Approvals, 2002-2008; APP Financial Results, 2003-2008 (US$ Million); Baxter ANDA Approvals for Injectables, 2002-2008; Baxter Financial Results, 2003-2007 (US$ Million); Bedford Laboratories ANDA Approvals, 2002-2008; Bedford Laboratories Sales, 2005-2007 (EUR & US$ Million); Hikma ANDA Approvals for Injectables, 2002-2008; Hikma Financial Results, 2004-2007 (US$ Million); Hospira ANDA Approvals, 2004-2008; Abbott ANDA Approvals for Injectables, 2002-2004; Hospira Tentative ANDA Approval; Hospira Financial Results, 2003-2007 (US$ Million); Orchid Healthcare ANDA Approvals for Injectables, 2005-2008; Orchid: Financial Results, 2003-2007; Paddock Laboratories ANDA Approvals, 2003-2006; PharmaForce ANDA Approvals for Injectables, 2002-2008; Approved ANDAs Acquired From Spectrum Pharmaceuticals; Sandoz ANDA Approvals for Injectables, 2005-2008; Sabex ANDA Approvals, 2003-2005; Eon Labs ANDA Approval for Injectable, 2005; Biochemie ANDA Approval for Injectable, 2002; Sandoz financial results, 2003-2007 (US$ Million); Sun Pharma ANDA Approvals for Injectables; Sun Pharma Tentative ANDA Approval for Injectable; Sun Pharma: Financial Results, 2003-2007; Teva Parenteral ANDA Approvals, 2002-2008; Teva Pharmaceuticals ANDA Approvals for Injectables, 2006; Pharmachemie ANDA Approvals for Injectables, 2004-2007; Teva Financial Results, 2003-2007 (US$ millions); Wockhardt ANDA Approvals for Injectables; Wockhardt Financial Results, 2003-2007 (Rs & US$ Million); FDA ANDA Approvals for Injectable Drugs, 2006-2008; Appendix II: UK MHRA Injectable Generic Approvals, 2006-2007
List of Figures: Generic Pharmaceutical Expenditure, 2007 (US$ billions); Generic Pharmaceutical Expenditure per capita, 2007 (US$); Generic Pharmaceutical Expenditure as % of Total, 2007; FDA ANDA Approvals by Therapeutic Area, 2003-2008; FDA ANDA Approvals by Therapeutic Area, 2003-2008 (%); FDA ANDA Approvals by Company 2003-2008; Competition for Generic Injectables; Regional Cancer Deaths as % of Total Deaths; Faslodex Sales, 2003A-2013E (US$ Million; Zoladex Sales, 2003A-2013E (US$ Million); Lupron Sales, 2003A-2013E (US$ Million); Taxotere Sales, 2003A-2013E (US$ Million); Abraxane Sales, 2005A-2013E (US$ Million); Camptosar Sales, 2003A-2013E (US$ Million); Eloxatin Sales, 2003A-2013E (US$ Million); Gemzar Sales, 2003A-2013E (US$ Million); Alimta Sales, 2004A-2013E (US$ Million); Rituxan/MabThera Sales, 2003A-2013E (US$ Million); Zometa/Aclasta/Reclast Sales, 2003A-2013E (US$ Million); Kytril Sales, 2003A-2013E (US$ Million); Neupogen Sales, 2003A-2013E (US$ Million); Neulasta Sales, 2003A-2013E (US$ Million); Neutrogin/Granocyte Sales, 2003A-2013E (US$ Million); Epogen/Eprex Sales, 2003A-2013E (US$ Million); Aranesp Sales, 2003A-2013E (US$ Million); NeoRecormon/Epogin Sales, 2003A-2013E (US$ Million); Merrem/Meropen Sales, 2003A-2013E (US$ Million); Zosyn Sales, 2003A-2013E (US$ Million); Primaxin Sales, 2003A-2013E (US$ Million); Levofloxacin Injection Sales, 2003E-2013E (US$ Million); Cancidas Sales, 2003A-2013E (US$ Million); Intron-A Sales, 2003A-2013E (US$ Million); PegIntron Sales, 2003A-2013E (US$ Million); Pegasys Sales, 2003A-2013E (US$ Million); Copaxone Sales, 2003A-2013E (US$ Million); Avonex Sales, 2003A-2013E (US$ Million); Rebif Sales, 2003A-2013E (US$ Million); Betaferon/Betaseron Sales, 2003A-2013E (US$ Million); Abilify Sales (all formulations), 2003A-2013E (US$ Million); Risperdal Consta Sales, 2007A-2013E (US$ Million); Zyprexa Sales (all formulations), 2003A-2013E (US$ Million); Lovenox Sales, 2003A-2013E (US$ Million); Arixtra Sales, 2004A-2013E (US$ Million); Integrilin Sales, 2003A-2013E (US$ Million); Angiomax Sales, 2003A-2013E (US$ Million); Humulin Sales, 2003A-2013E (US$ Million); Humalog Sales, 2003A-2013E (US$ Million); Lantus Sales, 2003A-2013E (US$ Million); Novo Nordisk Insulin Analogue Sales, 2003A-2013E (US$ Million); Genotropin Sales, 2003A-2013E (US$ Million); Humatrope Sales, 2003A-2013E (US$ Million); Novo Nordisk Growth Hormone Therapy Sales, 2003A-2013E (US$ Million); Nutropin/Protropin Sales, 2003A-2013E (US$ Million); Saizen/Serostim Sales, 2003A-2013E (US$ Million)

Abstract

This report provides…

Individual analysis of 48 leading therapies
Product forecasts by value 2008/2013
Comprehensive patent information by product and patent expiry opportunities to 2015
The market context for injectable drugs
Evaluation of companies competing in the sector
Analysis of significant litigation

Key therapy sectors covered...

Cancer
CNS
Cardiovascular
Anti-Infectives
Diabetes
Growth Disorders
Some of the most promising generic drug opportunities due to come off patent in the USA and Europe over the next few years are injectable...

This new report focuses on the market potential for sterile drugs delivered by injection or infusion. These drugs are used to treat major illnesses, such as cancer, central nervous system (CNS) disorders, acute cardiovascular conditions and severe infections. More than one third of the injectable generics approved in the US during the last five years are used in cancer therapy. A further 23% are anti-infectives, 16% are used in the CNS setting and 9% are used for cardiovascular therapy.

A relatively small number of injectable drugs have received significant attention from generic companies, resulting in the approval of numerous versions following patent expiry. Some of these are high profile cancer drugs. For example, when Bristol-Myers Squibb’s Paraplatin (carboplatin) became generically available 11 companies received FDA approval for generic versions.

Significant opportunities still exist
Obviously where intense competition exists, the potential for significant market share is reduced. The vast majority of injectable generics are, however, less hotly contested. For more than half of the injectable generics approved since 2003, just one or two manufacturers have received ANDA approvals and over 85% of molecules have less than five generic competitors. While the potential market may not be as valuable for these products, with less competition for price reductions, higher profit margins than have traditionally been available for oral generics are possible. Companies are, therefore, able to capitalise on opportunities for specialty injectable generics in niche areas.

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Injectable Generic Drugs: Prospects & Opportunities to 2013

Table of Contents

Abstract