吸入型及鼻腔噴霧式非專利藥之新機會：2010年 是由出版商Espicom Business Intelligence在2010年03月所出版的。
這份英文市場調查報告書包含Pages: 128 價格從美金1740起跳。
吸入型及經鼻藥劑市場於2009年創下超越200億美金之銷售紀錄。而此多為氣喘、慢性阻塞性肺疾病、過敏性鼻炎、流行性感冒等之治療。長遠來看，今後開發之候補藥將大幅提升治療領域，對非專利藥品產業而言極具市場魅力。
本報告為，綜觀分析吸入型及鼻腔噴霧式非專利藥市場，並匯整目前非專利醫藥品之產品概要、今後10年專利將失效之藥劑等，以下列摘要形式闡述。
序
實施概要
概要
- 主要非專利藥市場
- 吸入型、鼻腔噴霧劑
- 美國非專利藥之關鍵途徑機會
- 市場領導者及專利失效
- FDA認可之非專利藥
氣喘及COPD（慢性阻塞性肺疾病）
- Flixotide/Flovent
- Serevent
- Seretide/Advair
- Pulmicort
- Symbicort
- Foradil
- Combivent
- Xopenex
- Spiriva
過敏性鼻炎
- Flixonase
- Rhinocort
- Nasonex
- Nasacort
- Astelin
流行性感冒
偏頭痛及叢集性頭痛
骨質疏鬆症
麻醉
企業簡介
- Apotex
- Baxter Healthcare
- Beximco Pharmaceuticals
- Cipla
- Hi-Tech Pharmacal
- Hovione FarmaCiencia
- Mylan
- Nephron Pharmaceuticals
- Piramal Healthcare
- Ranbaxy
- Roxane Laboratories
- Sandoz
- Teva Pharmaceuticals Industries
- Watson Pharmaceuticals
資訊來源
Abstract
Providing...
- Product forecasts by value to 2014 for 18 leading therapies
- Patent expiry opportunities to 2020
- Inhalable and nasal spray generics in their market context
- A review of pipeline developments that will affect the sector going forward
- Competitive evaluation for 14 significant companies
Use this report...
- To identify product and market opportunities and risks
- Understand the patent status and current challenges
- Assess the longer term potential of the sector
- Evaluate the competitive environment and identify potential partners
With high-profile inhalable drugs coming off patent, the prospects for the
generic sector should be good - but only if companies can overcome production,
regulatory and litigation hurdles.
The inhalation and intranasal drugs discussed in detail in this report had
combined sales exceeding US$20 billion in 2009. These drugs are used in the
treatment of asthma, COPD, allergic rhinitis, influenza, migraine and
osteoporosis. In the longer term, novel inhalation and intranasal drug
candidates which are being developed now could greatly expand the therapeutic
coverage of these drug delivery technologies and potentially provide a
lucrative future for the generic industry.
Asthma/COPD: A valuable sector...
The biggest selling inhalable drugs for the treatment of asthma and/or COPD by
value, are GlaxoSmithKline' s Seretide/Advair (fluticasone+salmeterol) with
sales of £4,977 million (US$7,794 million) in 2009, Boehringer
Ingelheim' s Spiriva (tiotropium) with sales of EUR 2,070 million (US$3,046
million) in 2008, and AstraZeneca' s Symbicort (budesonide+formoterol) with
sales of US$2,294 million in 2009.
...facing patent expiry
GSK' s combination patent on Seretide/Advair will expire in the US in September
2010 and in most European markets in 2013; the UK patent was revoked.
Combination patents covering Symbicort have been revoked in Europe, and
AstraZeneca' s data exclusivity will end in August 2010. The US patents for
Symbicort begin to expire in 2011. The US patents for Spiriva begin to expire
from December 2012, although there are patents running right up to 2023.
From emerging specialist manufacturers to established companies seeking new
opportunities, new products in niche markets are increasingly being seen as a
route to a competitive edge.
That is why this report focuses on the opportunities for inhalation and
nasal spray generic drugs.
The report provides a complete review of the emerging opportunities and
operating environment for inhalation and nasal spray drugs. It reviews
products currently available generically and assesses the prospects for those
drugs losing patent protection over the next 10 years. The whole sector is put
in the context of the global generic market and the significant players are
assessed.
About the Author
The report has been researched and written by Espicom' s Senior Market Analyst,
Karen Holmes. Karen has over 14 years pharmaceutical and healthcare
market analysis experience.
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
- 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)
- Serevent (salmeterol xinafoate)
- Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
- Patents
- Generic Company Activity
- Patent Challenges
- Sandoz/Vectura
- Market Outlook
- Pulmicort (budesonide)
- Patents
- Generic Company Activity
- Market Outlook
- Symbicort (budesonide+formoterol)
- Patents
- Generic Company Activity
- Market Outlook
- Foradil (formoterol)
- Combivent (ipratropium bromide+salbutamol)
- Patents
- Generic Company Activity
- Market Outlook
- Xopenex (levalbuterol)
- Patents
- Generic Company Activity
- Breath (Watson)
- Barr (Teva)
- Mylan
- Market Outlook
- Spiriva (tiotropium)
- Allergic Rhinitis
- Flixonase (fluticasone propionate)
- Generic Competition
- Market Outlook
- Rhinocort (budesonide)
- Patents
- Generic Company Activity
- Market Outlook
- Nasonex (mometasone furoate)
- Patents
- Generic Company Activity
- 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)
- Osteoporosis
- Miacalcin (calcitonin-salmon)
- Further Development
- Patents
- Generic Company Activity
- Sandoz
- MDRNA/Par Pharmaceutical
- Apotex
- Market Outlook
- Fortical (calcitonin-salmon [rDNA origin])
- Anaesthesia
- Ultane (sevoflurane)
- Patents
- Generic Competition
- Market Outlook
- Suprane (desflurane)
- Patents
- Generic Competition
- Company Profiles
- Apotex
- Inhalation and Nasal Spray Products
- Baxter Healthcare
- Inhalation Products
- Financials
- Beximco Pharmaceuticals
- Cipla
- Products
- Development agreement with Akorn
- Financials
- Hi-Tech Pharmacal
- Hovione FarmaCiencia
- Products
- Hovione licenses inhaler technology to Sankyo/Biota
- Financials
- Mylan
- Nephron Pharmaceuticals
- Piramal Healthcare
- Products
- Financials
- Acquisitions
- Minrad International
- RxElite' s inhalation anaesthetic gas distribution business
- Ranbaxy
- Roxane Laboratories
- Sandoz
- Teva Pharmaceutical Industries
- Products
- Asthma & COPD
- Allergic Rhinitis
- Financials
- Watson Pharmaceuticals
- Products
- Financials
- Acquisitions
- Eden Biodesign
- Arrow Group
- 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, 2002-2009
- US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2009 Sales
(US$ Million)
- US FDA Approved Generic Asthma/COPD Inhalation Products
- Flixotide/Flovent Sales, 2005-2009 (£ & US$ Million)
- Flovent Diskus US Patents
- Flovent HFA US Patents
- Serevent Sales, 2005-2009 (£ & US$ Million)
- Serevent US Patents
- Seretide/Advair Sales, 2005-2009 (£ & US$ Million)
- Advair US Patents
- Pulmicort Sales, 2005-2009 (US$ Million)
- Pulmicort US Patents
- Symbicort Sales, 2005-2009 (US$ Million)
- Symbicort US Patents
- Foradil Sales, 2005-2009 (US$ Million)
- Foradil US Patents
- Foradil Certihaler US Patents
- Combivent Sales, 2004-2008 (EUR & US$ Million)
- Combivent US Patent
- Xopenex Sales, 2004-2008 (US$ Million)
- Xopenex US Patents
- Spiriva Sales, 2004-2008 (EUR & US$ Million)
- Spiriva US Patents
- US Patent expiry for Selected Nasal Spray Allergy Therapies; 2009 Sales
(US$ Million)
- US FDA Approved Generic Allergic Rhinitis Nasal Spray Products
- Flixonase/Flonase Sales, 2005-2009 (£ & US$ Million)
- Rhinocort Sales, 2005-2009 (US$ Million)
- Rhinocort US Patents
- Nasonex Sales, 2004-2008 (US$ Million)
- Nasonex US Patents
- Nasacort Sales, 2005-2009 (EUR & US$ Million)
- Nasacort US Patents
- Astelin Sales, 2006-2009 (SEK & US$ Million)
- Astelin US Patent
- Relenza Sales, 2005-2009 (£ & US$ Millions)
- Relenza US Patents
- Imigran/Imitrex Sales, 2005-2009 (£ & US$ Million)
- Imitrex US Patents
- Zomig Sales, 2005-2009 (US$ Million)
- Zomig US Patents
- Miacalcic/Miacalcin Sales, 2003-2007 (US$ Million)
- Miacalcin US Patents
- Fortical US Patent
- Ultane/Sevorane Sales, 2004-2008 (US$ Million)
- Ultane US Patents
- FDA ANDA Approvals for Sevoflurane
- Suprane US Patents
- Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2009
- Baxter Healthcare ANDA Approvals for Inhalable Drugs
- Baxter Financial Results, 2004-2008 (US$ Million)
- Beximco Pharmaceuticals Financial Results, 2004-2008
- Cipla Financial Results, 2005-2009
- Hi-Tech Pharmacal ANDA Approval for Nasal Spray
- Hi-Tech Pharmacal Financial Results, 2005-2009 (US$ millions)
- Dey ANDA Approvals, 1987-2009
- Mylan Sales, 2005-2008 (US$ Million)
- Nephron Pharmaceuticals ANDA Approvals, 1997-2007
- Minrad International ANDA Approval
- Piramal Healthcare: Financial Results, 2005-2009
- Ranbaxy Financial Results, 2004-2008
- Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray
Products, 2002-2008
- Roxane Sales, 2005-2007 (EUR & US$ Million)
- Sandoz ANDA Approval for Inhalation Product, 2006
- Sandoz financial results, 2004-2008 (US$ Million)
- Teva ANDA Approvals for Inhalable products, 2007-2008
- Teva Financial Results, 2004-2008 (US$ millions)
- Watson ANDA Approvals for Inhalable Products, 2007
- Cobalt and Breath ANDA Approvals for Inhalable Products, 2003-2008
- Watson Financial Results, 2004-2008 (US$ Million)
List of Figures
- Generic Pharmaceutical Expenditure, 2009 (US$ Billions)
- Generic Pharmaceutical Expenditure per capita, 2009 (US$)
- Generic Pharmaceutical Expenditure as % of Total, 2009
- FDA ANDA Approvals by Indication, 2002-2009
- FDA ANDA Approvals by Indication, 2002-2009 (%)
- FDA ANDA Approvals by Company, 2002-2009
- Flixotide/Flovent Sales, 2004A-2014E (US$ Million)
- Serevent Sales, 2004A-2014E (US$ Million)
- Seretide/Advair Sales, 2004A-2014E (US$ Million)
- Pulmicort Sales, 2004A-2014E (US$ Million)
- Symbicort Sales 2004A-2014E (US$ Million)
- Foradil Sales 2004A-2014E (US$ Million)
- Combivent Sales, 2004A-2014E (US$ Million)
- Xopenex Sales, 2004A-2014E (US$ Million)
- Spiriva Sales 2004A-2014E (US$ Million)
- Flixonase/Flonase Sales, 2004A-2014E (US$ Million)
- Rhinocort Sales, 2004A-2014E (US$ Million)
- Nasonex Sales, 2004A-2014E (US$ Million)
- Nasacort Sales, 2004A-2014E (US$ Million)
- Astelin Sales, 2006A-2014E (US$ Million)
- Imigran/Imitrex Sales, 2004A-2014E (US$ Million)
- Zomig Sales, 2004A-2014E (US$ Million)
- Miacalcin Sales, 2004A-2014E (US$ Million)
- Sevoflurane Projected Sales, 2004A-2014E (US$ Million)
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