Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs

Table of Contents

• Foreword
• Executive Summary
• Generic Market Overview
• Inhalation and Nasal Spray Drug Delivery
  • Asthma and COPD
  • Allergic rhinitis
  • Influenza
  • Diabetes
  • Pain, Migraine and other CNS disorders
  • Osteoporosis
  • Anaesthesia
  • Pulmonary arterial hypertension
  • Nocturia
  • Potential inhalation drugs for anthrax, cystic fibrosis and erectile dysfunction
  • Critical Path Opportunities for Generic Drugs in the US
• Asthma & COPD
  • Flixotide/Flovent (fluticasone propionate)
    • Market Outlook
  • Serevent (salmeterol xinafoate)
    • Market Outlook
  • Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
    • Patents
    • Patent Challenge
    • Safety Issues
    • Market Outlook
  • Pulmicort (budesonide)
    • Patent Challenge
    • Market Outlook
  • Combivent (ipratropium bromide+salbutamol)
    • Market Outlook
  • Xopenex (levalbuterol)
    • Patent Challenges
    • Market Outlook
• Allergic rhinitis
  • Flixonase (fluticasone propionate)
    • Generic Competition
    • Market Outlook
  • Rhinocort (budesonide)
    • Market Outlook
  • Nasonex (mometasone furoate)
    • Market Outlook
  • Nasacort (triamcinolone acetonide)
    • Patent Challenge
    • Market Outlook
• Influenza
  • Relenza (zanamivir)
    • Litigation
    • Market Outlook
• Migraine
  • Imigran (sumatriptan)
    • Patents
    • Generic Competition
    • Market Outlook
  • Zomig (zolmitriptan)
    • Patents
    • Market Outlook
• Osteoporosis
  • Miacalcin (calcitonin-salmon)
    • Further Development
    • Patents & Generic Activity
  • Fortical (calcitonin-salmon (rDNA origin))
    • Generic Activity
  • Market Outlook
• Anaesthesia
  • Ultane (sevoflurane)
    • Generic Competition
    • Market Outlook
  • Suprane (desflurane)
    • Generic Competition
• Company Profiles
• Amphastar Pharmaceuticals
  • Products
• Apotex
  • Inhalation and Nasal Spray Products
• Barr Pharmaceuticals
  • Product Development
  • Financials
• Baxter Healthcare
  • Inhalation Products
  • Financials
  • Acquisitions
• Beximco Pharmaceuticals
  • Products
  • Financials
• Cipla
  • Products
  • Financials
• Hi-Tech Pharmacal
  • Products
  • Financials
• Hovione FarmaCiencia
  • Products
  • Financials
• Merck Generics
  • Financials
  • Products
  • Dey
    • Inhalation and Nasal Spray Products
    • Financials
• Morton Grove Pharmaceuticals
  • Inhalation Products
• Nephron Pharmaceuticals
  • Products
• Ranbaxy Laboratories
  • Products
  • Financials
• Roxane Laboratories
  • Products
  • Financials
• RxElite
  • Products
• Sandoz
  • Inhalation Products
  • Financials
• Teva Pharmaceutical Industries
  • Products
    • Asthma & COPD
    • Allergic Rhinitis
  • Financials
• Watson Pharmaceuticals
  • Products
  • Financials
• SOURCES
• Espicom Sources
• Others

List of Tables

• Generic Pharmaceutical Expenditure in Leading Markets, 2006
• Leading Generic Drug Markets, 2006-2011 (US$ Millions)
• Population of Leading Generic Markets, 2006-2011 (000s)
• Per Capita Expenditure in Leading Generic Drug Markets, 2006-2011 (US$)
• US Patent Expiry for Major Inhalation and Nasal Spray Drugs, 2006-2017
• FDA ANDA Approvals of Inhalation and Nasal Spray Generics, 2002-2007
• FDA Tentative ANDA Approvals of Inhalation and Nasal Spray Generics, 2007
• US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2006 Sales (US$ Millions)
• US FDA Approved Generic Asthma/COPD Inhalation Products
• Flixotide/Flovent Sales, 2002-2006 (£ & US$ Million)
• Serevent Sales, 2002-2006 (£ & US$ Million)
• Seretide/Advair Sales, 2002-2006 (£ & US$ Million)
• Pulmicort Sales, 2002-2006 (US$ Million)
• Combivent Sales, 2002-2006 (EUR & US$ Million)
• Xopenex Sales, 2002-2006 (US$ Million)
• US Patent Expiry for Selected Nasal Spray Allergy Therapies; 2006 Sales (US$ Millions)
• US FDA Approved Generic Allergic Rhinitis Nasal Spray Products
• Flixonase/Flonase Sales, 2002-2006 (£ & US$ Million)
• Rhinocort Sales, 2002-2006 (US$ Million)
• Nasonex Sales, 2002-2006 (US$ Million)
• Nasacort Sales, 2002-2006 (EUR & US$ Million)
• Relenza Sales, 2005-2006 (£ & US$ Millions)
• Imigran/Imitrex Sales, 2002-2006 (£ & US$ Million)
• Zomig Sales, 2002-2006 (US$ Million)
• Miacalcic/Miacalcin Sales, 2002-2006 (US$ Million)
• Ultane/Sevorane Sales, 2003-2006 (US$ Million)
• Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2007
• Barr Pharmaceuticals Financial Results, 2002-06 (US$ million)
• Baxter Healthcare ANDA Approvals for Inhalable Drugs, 2002
• Baxter Financial Results, 2002-2006 (US$ Million)
• Beximco Pharmaceuticals Financial Results, 2005
• Cipla Financial Results, 2003-2006
• Hi-Tech Pharmacal Fiscal Year Results, 2005-2006 (US$ millions)
• Merck Generics Financial Results, 2003-06 (EUR Millions)
• Dey ANDA Approvals, 1987-2007
• Dey Sales, 2003-2006
• Morton Grove ANDA Approval for Inhalation Products, 1999-2007
• Nephron Pharmaceuticals ANDA Approvals, 1997-2007
• Ranbaxy Financial Results, 2003-2006
• Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray Products, 2002-2007
• Roxane Net Sales, 2005-2006 (EUR & US$ Million)
• RxElite ANDA Approvals for Inhalation Products
• Sandoz ANDA Approval for Inhalation Product, 2006
• Sandoz Financial Results, 2004-06 (US$ millions)
• Teva Financial Results, 2002-2006 (US$ millions)
• Watson Financial Results, 2002-2006 (US$ Million)

List of Figures

• Per Capita Spending on Generic Pharmaceuticals, 2006 (US$)
• Per Capita Spending on Generic Pharmaceuticals, 2011 (US$)
• Flixotide/Flovent Projected Sales, 2006-2011 (US$ Million)
• Salmeterol Xinafoate Projected Sales, 2006-2011 (US$ Million)
• Salmeterol+Fluticasone Combination Projected Sales, 2006-2011 (US$ Million)
• Pulmicort Projected Sales, 2006-2011 (US$ Million)
• Combivent Projected Sales, 2006-2011 (US$ Million)
• Levalbuterol Projected Sales, 2006-2011 (US$ Million)
• Fluticasone Propionate Nasal Spray Projected Sales, 2006-2011 (US$ Million)
• Rhinocort Projected Sales, 2006-2011 (US$ Million)
• Nasonex Projected Sales, 2006-2011 (US$ Million)
• Triamcinolone Acetonide Nasal Spray Projected Sales, 2006-2011 (US$ Million)
• Imigran/Imitrex Projected Sales, 2006-2011 (US$ Million)
• Zomig Projected Sales, 2006-2011 (US$ Million)
• Calcitonin-salmon Nasal Spray Projected Sales, 2006-2011 (US$ Million)
• Sevoflurane Projected Sales, 2006-2011 (US$ Million)