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Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs

Published by: Espicom Healthcare Intelligence

Published: May. 14, 2007 - 110 Pages


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)

Abstract

Providing…
  • Product forecasts by value 2006/2011;
  • Patent expiry opportunities to 2016;
  • Generic market context;
  • Competitive evaluation with 18 company reviews

Exciting opportunities in this high growth area can be expected over the next 10 years. At least nine significant products will lose patent protection in key markets and this number could increase depending on the outcome of patent challenges.



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