Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2008

Table of Contents

Foreword

Executive Summary

Overview

• Leading Generic Markets
• Inhalation and Nasal Spray Drugs
  • Asthma and COPD
  • Cystic fibrosis
  • Allergic rhinitis
  • Influenza
  • Migraine, pain and other CNS disorders
  • Osteoporosis
  • Anaesthesia
  • Pulmonary arterial hypertension
  • Anthrax
  • Erectile dysfunction
  • Nocturia
  • Diabetes
• Critical Path Opportunities for Generic Drugs in the US
• Market Leaders and Patent Expiry
• FDA Approved Generics

Asthma & COPD

• Flixotide/Flovent (fluticasone propionate)
  • Market Outlook
• Serevent (salmeterol xinafoate)
  • Patents
  • Market Outlook
• Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
  • Safety Issues
  • Patents
  • Generic Company Activity
  • Market Outlook
• Pulmicort (budesonide)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Symbicort (budesonide+formoterol)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Combivent (ipratropium bromide+salbutamol)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Xopenex (levalbuterol)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Spiriva (tiotropium)
  • Patents
  • Market Outlook

Allergic rhinitis

• Flixonase (fluticasone propionate)
  • Generic Competition
  • Market Outlook
• Rhinocort (budesonide)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Nasonex (mometasone furoate)
  • Patents
  • Market Outlook
• Nasacort (triamcinolone acetonide)
  • Patents
  • Generic Company Activity
  • Market Outlook
• Astelin (azelastine hydrochloride)
  • Patents
  • Generic Company Activity
  • Market Outlook

Influenza

• Relenza (zanamivir)
  • Litigation
  • Patents
  • Generic Company Activity
  • Market Outlook

Migraine and Cluster Headache

• Imigran (sumatriptan)
  • Patents
  • Generic Competition
  • Market Outlook
• Zomig (zolmitriptan)
  • Patents
  • Market Outlook

Osteoporosis

• Miacalcin (calcitonin-salmon)
  • Further Development
  • Patents
  • Generic Company Activity
  • Market Outlook
• Fortical (calcitonin-salmon [rDNA origin])
  • Patents
  • Generic Activity

Anaesthesia

• Ultane (sevoflurane)
  • Patents
  • Generic Competition
  • Market Outlook
• Suprane (desflurane)
  • Patents
  • Generic Competition

Company Profiles

• Amphastar Pharmaceuticals
  • Products
• Apotex
  • Inhalation and Nasal Spray Products
• Barr Pharmaceuticals
  • Product Development
  • Financials
• Baxter Healthcare
  • Inhalation Products
  • Financials
• Beximco Pharmaceuticals
  • Products
  • Financials
• Cipla
  • Products
  • Development agreement with Akorn
  • Financials
• Hi-Tech Pharmacal
  • Products
  • Financials
• Hovione FarmaCiencia
  • Products
  • Hovione licenses inhaler technology to Sankyo/Biota
  • Financials
• Mylan
  • Products
  • Financials
• Nephron Pharmaceuticals
  • Products
• Ranbaxy
  • Products
  • Financials
• Roxane Laboratories
  • Products
  • Financials
• RxElite
  • Products
  • Financials
• Sandoz
  • Products
  • Financials
• Teva Pharmaceutical Industries
  • Products
  • Asthma & COPD
  • Allergic Rhinitis
  • Financials
• Watson Pharmaceuticals
  • Products
  • Financials
• SOURCES
  • Espicom Sources
  • Others

List of Tables

• US Patent Expiry for Major Inhalation/Nasal Spray Drugs
• FDA ANDA Approvals for Inhalation and Nasal Spray Drugs, 2000-2008
• US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2007 Sales (US$ Million)
• US FDA Approved Generic Asthma/COPD Inhalation Products
• Flixotide/Flovent Sales, 2003-2007 (£ & US$ Million)
• Serevent Sales, 2003-2007 (£ & US$ Million)
• Serevent US Patents
• Seretide/Advair Sales, 2003-2007 (£ & US$ Million)
• Advair US Patents
• Pulmicort Sales, 2003-2007 (US$ Million)
• Pulmicort US Patents
• Symbicort Sales, 2003-2007 (US$ Million)
• Symbicort US Patents
• Combivent Sales, 2003-2007 (EUR & US$ Million)
• Combivent US Patent
• Xopenex Sales, 2003-2007 (US$ Million)
• Xopenex US Patents
• Spiriva Sales, 2003-2007 (EUR & US$ Million)
• Spiriva US Patents
• US Patent expiry for Selected Nasal Spray Allergy Therapies; 2007 Sales (US$ Million)
• US FDA Approved Generic Allergic Rhinitis Nasal Spray Products
• Flixonase/Flonase Sales, 2003-2007 (£ & US$ Million)
• Rhinocort Sales, 2003-2007 (US$ Million)
• Rhinocort US Patents
• Nasonex Sales, 2003-2007 (US$ Million)
• Nasonex US Patents
• Nasacort Sales, 2003-2007 (EUR & US$ Million)
• Nasacort US Patents
• Astelin Sales, 2006-2007 (SEK & US$ Million)
• Astelin US Patent
• Relenza Sales, 2005-2007 (£ & US$ Millions)
• Relenza US Patents
• Imigran/Imitrex Sales, 2003-2007 (£ & US$ Million)
• Imitrex US Patents
• Zomig Sales, 2003-2007 (US$ Million)
• Zomig US Patents
• Miacalcic/Miacalcin Sales, 2003-2007 (US$ Million)
• Miacalcin US Patents
• Fortical US Patent
• Ultane/Sevorane Sales, 2003-2007 (US$ Million)
• Ultane US Patents
• FDA ANDA Approvals for Sevoflurane
• Suprane US Patents
• Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2007
• Financial Results, 2006-07 (US$ million)
• Baxter Healthcare ANDA Approvals for Inhalable Drugs
• Baxter Financial Results, 2003-2007 (US$ Million)
• Beximco Pharmaceuticals Financial Results, 2004-2007
• Cipla: Financial Results, 2003-2007
• Hi-Tech Pharmacal ANDA Approval for Nasal Spray
• Hi-Tech Pharmacal Financial Results, 2005-2008 (US$ millions)
• Dey ANDA Approvals, 1987-2008
• Dey Tentative ANDA Approvals for Inhalation Products
• Nephron Pharmaceuticals ANDA Approvals, 1997-2007
• Ranbaxy Financial Results, 2003-2007
• Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray Products, 2002-2008
• Roxane Sales, 2005-2007 (EUR & US$ Million)
• RxElite ANDA Approvals for Inhalation Products
• Financial Results, 2006-2007 (US$ Million)
• Sandoz ANDA Approval for Inhalation Product, 2006
• Sandoz financial results, 2003-2007 (US$ Million)
• Teva ANDA Approval for Inhalable product, 2007
• Teva Financial Results, 2003-2007 (US$ millions)
• Watson ANDA Approvals for Inhalable Products, 2007
• Watson Financial Results, 2003-2007 (US$ Million)

List of Figures

• Generic Pharmaceutical Expenditure, 2007 (US$ billions)
• Generic Pharmaceutical Expenditure per capita, 2007 (US$)
• Generic Pharmaceutical Expenditure as % of Total, 2007
• FDA ANDA Approvals by Therapeutic Area, 2002-2008
• FDA ANDA Approvals by Therapeutic Area, 2002-2008 (%)
• FDA ANDA Approvals by Company, 2002-2008
• Flixotide/Flovent Sales, 2003A-2013E (US$ Million)
• Serevent Sales, 2003A-2013E (US$ Million)
• Seretide/Advair Sales, 2003A-2013E (US$ Million)
• Pulmicort Sales, 2003A-2013E (US$ Million)
• Symbicort Sales 2003A-2013E (US$ Million)
• Combivent Sales, 2003A-2013E (US$ Million)
• Xopenex Sales, 2003A-2013E (US$ Million)
• Spiriva Sales 2003A-2013E (US$ Million)
• Flixonase/Flonase Sales, 2003A-2013E (US$ Million)
• Rhinocort Sales, 2003A-2013 (US$ Million)
• Nasonex Sales, 2003A-2013E (US$ Million)
• Nasacort Sales, 2003A-2013E (US$ Million)
• Astelin Sales, 2006A-2013E (US$ Million)
• Imigran/Imitrex Sales, 2003A-2013E (US$ Million)
• Zomig Sales, 2003A-2013E (US$ Million)
• Miacalcin Sales, 2003A-2013E (US$ Million)
• Sevoflurane Projected Sales, 2008-2013 (US$ Million)