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Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs


Description: 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.

The inhalation and intranasal drugs discussed in this new report had combined sales exceeding US$18 billion in 2006. These drugs are used in the treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis, and in general anaesthesia.

More importantly, from a generic industry perspective is that at least 9 significant products will lose patent protection in key markets over the next 10 years, and this number could increase depending on the outcome of patent challenges.

The generics market is undergoing radical restructuring, with much rationalisation of the corporate landscape. In such a competitive cauldron companies are now seeking not just new opportunities but opportunities which combine good profit levels and a degree of product novelty - both of which are available in the inhalation and nasal spray market.

IDENTIFY THE OPPORTUNITIES AND THE COMPANIES INVOLVED

This new report provides industry planners, commercial developers and the investment community with a thorough review of the potential for generic inhalation and nasal spray drugs over the next 5 years. Packed with primary source information and original market forecasts, it takes a balanced view of the players and products that will shape this high value market sector.

THE REPORT PROVIDES...

- Full 5-year product/market forecasts by value to 2011
- Generic market context
- Reviews of 18 leading players
- Analysis of significant litigation
- Patent expiry opportunities to 2016


JUST SOME OF THE QUESTIONS ANSWERED BY THE REPORT:

- What are the most promising future product opportunities and when do they lose patent protection?
- What drug delivery challenges must companies overcome if they are to really benefit in the marketplace?
- What will be the effect on the value of GSK’s blockbusting Advair in 2011 assuming generic competition starts in 2008?
- Which therapy areas offer the best potential for ANDA development?


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

INHALATION & NASAL SPRAY GENERIC DRUGS

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

INHALATION & NASAL SPRAY GENERIC DRUGS

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

INHALATION & NASAL SPRAY GENERIC DRUGS

Teva Pharmaceutical Industries
Products
Asthma & COPD
Allergic Rhinitis.
Financials
Watson Pharmaceuticals
Products
Financials

SOURCES

Espicom Sources
Others

INHALATION & NASAL SPRAY GENERIC DRUGS

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
INHALATION & NASAL SPRAY GENERIC DRUGS
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)


Companies Mentioned -Amphastar Pharmaceuticals -Apotex -Barr Pharmaceuticals -Baxter Healthcare -Beximco Pharmaceuticals -Cipla -Hi-Tech Pharmacal -Hovione FarmaCiencia -Merck Generics -Morton Grove Pharmaceuticals -Nephron Pharmaceuticals -Ranbaxy Laboratories -Roxane Laboratories -RxElite -Sandoz -Teva Pharmaceutical Industries -Watson Pharmaceuticals


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