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Published by: Espicom Healthcare Intelligence
Published: Oct. 15, 2008 - 122 Pages
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)
AbstractProviding…
Product forecasts by value 2007/2013 for 20 leading therapies
Patent expiry opportunities to 2018
Inhalable and nasal spray generics in market context
A review of pipeline developments which will affect the sector going forward
Competitive evaluation for 17 significant companies
Use this report...
To identify product and market opportunities
Understand the patent status and current challenges
Assess the longer term potential of the sector
Evaluate the competitive environment
During the next ten years, at least 12 significant drugs in this sector 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 detail in this report had combined sales exceeding US$22 billion in 2007. These drugs are used in the treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis, and in general anaesthesia.
Successful IP challenges and regulatory approval will be critical
With major blockbusters in the Asthma/COPD sector, the generic industry is keen to secure a slice of the action. However, they must overcome well defended IP claims.
The biggest prize is GSK’s US$7 billion product Seretide/Advair. The patents on the specific combination of fluticasone propionate and salmeterol xinafoate are due to expire in 2010 in the US and in 2013 in Europe, including Supplementary Protection Certificate extensions, after which generic companies are expected to be able to enter the market.
Patent expiry in the US is not necessarily a gateway to generic competition, however, due to the historic difficulty in gaining approval for inhalable generics from the FDA. Flixotide/Flovent has been off patent for some time and, while generic versions are available in Europe, generics have yet to be approved in the US and the product remains a top seller for GSK.
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