表紙
市場調査レポート

吸入式および鼻腔スプレー式ジェネリック医薬品市場

Inhalation & Nasal Spray Generic Drugs 2013

発行 Espicom Business Intelligence 商品コード 115822
出版日 ページ情報 英文 106 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=105.69円で換算しております。
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吸入式および鼻腔スプレー式ジェネリック医薬品市場 Inhalation & Nasal Spray Generic Drugs 2013
出版日: 2013年11月29日 ページ情報: 英文 106 Pages
概要

世界市場で364億米ドルの売上を記録した呼吸器治療用処方薬のおよそ4分の3は、吸入式または鼻腔スプレー技術を使用しています。2012年に喘息とCOPDの治療に使用された医薬品トップ5の収益の合計は、約180億米ドルに達しました。

当レポートでは、吸入式および鼻腔スプレー式薬剤市場について包括的に分析しており、主なジェネリック医薬品の概要を、概略以下の構成でお届けします。

序文

エグゼクティブサマリー

呼吸器治療薬市場

  • 市場リーダー
  • ジェネリック医薬品
    • ジェネリック医薬品開発業者における課題
    • 米国におけるジェネリック医薬品のクリティカルパスの機会
    • FDAはMDIのためのドラフトガイダンスを発表

喘息および慢性閉塞性肺疾患(COPD)

  • 市場概要
    • 喘息
    • COPD
    • 市場リーダー
    • 注目すべき新製品
    • ジェネリック医薬品との競合
  • Flixotide/Flovent
  • Seretide/Advair
  • Serevent
  • Ventolin
  • Foradil
  • Pulmicort
  • Symbicort
  • Xopenex
  • Asmanex Twisthaler
  • Alvesco
  • Combivent
  • Spiriva
  • Brovana
  • Onbrez Breezhaler/Arcapta Neohaler

アレルギー性鼻炎

  • 市場概要
    • 市場リーダー
    • 注目すべき新製品
    • 認可済みのジェネリック医薬品
  • Nasonex
  • Flixonase/Flonase
  • Avamys/Veramyst
  • Rhinocort
  • Nasacort
  • Astelin/Astepro
  • Omnaris

競合ジェネリック医薬品メーカー

  • Actavis
  • Apotex
  • Cipla
  • Mylan
  • Nephron Pharmaceuticals
  • Sandoz
  • Teva Pharmaceuticals Industries

情報源

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: RF218

Around three quarters of the US$36.4 billion respiratory prescription drugs market comprises drugs that are delivered using inhalation or nasal spray technologies. The top five drugs used in the treatment of asthma and chronic obstructive pulmonary disease (COPD) attracted combined revenues of around US$18.0 billion in 2012. All five are blockbuster drugs. In terms of revenue, the current market leaders are GlaxoSmithKline's Seretide/Advair (fluticasone propionate+salmeterol xianfoate), Boehringer Ingelheim's Spiriva (tiotropium bromide) and AstraZeneca's Symbicort (budesonide+formoterol). In the allergy segment, the leading nasal spray therapy used in the treatment of allergic rhinitis is Merck & Co's Nasonex (mometasone furoate).

High revenue originator drugs undoubtedly attract interest from prospective generic competitors. Unlike the oral generics market, however, where numerous companies typically compete for a revenue share, relatively few companies have the technology and expertise to compete in the market for generic inhalation and nasal spray products.

This report features the latest in-depth reviews of the market leaders, new products and competition across the wider respiratory drugs market and within the Asthma/ COPD and Allergic Rhinitis sectors. While also detailing information on the patents and generic company activity for products such as Seretide/Advair, Flixotide/Flovent, Ventolin and Combivent for Asthma/COPD and Nasonex, Rhinocort and Omnaris for Allergic Rhinitis... plus many more!

What this report contains:

Executive Summary

Comprehensive overview of the challenges and opportunities across the respiratory drugs market, and the FDA's new product guidance forgeneric inhalers

Asthma/COPD sector breakdown with market overview, market leaders, new products and competition

Detailed look at the leading asthma/COPD products and their approvals, patents and market outlook

Allergic rhinitis sector breakdown with market overview, market leaders, new products and competition

Detailed look at the leading allergic rhinitis products and their approvals, patents and market outlook

Over 70 exportable tables and charts detailing patents, sales and FDA approvals (where available)

The Inhalation and Nasal Spray Generics report is the foolproof business resource for any industry executive who needs to fully understand the current products and future prospects for generics in the respiratory drugs market. The need for hard facts and statistics to back up everyday business decisions is essential and it is this report that can provide you with the answers.

Table of Contents

FOREWORD 1

EXECUTIVE SUMMARY 3

RESPIRATORY DRUGS MARKET 5

  • Market Leaders 5
  • Generics 7
    • Challenges for Generic Developers 8
    • Critical Path Opportunities for Generic Drugs in the US 9
    • FDA Publishes Draft Guidance for MDIs 10

ASTHMA & COPD 12

  • Market Overview 12
    • Asthma 12
    • COPD 12
    • Market Leaders 13
    • New Products to Watch 15
    • Generic Competition 15
  • Flixotide/Flovent (fluticasone propionate) 17
    • Mode of Action 17
    • Approvals 17
    • Patents 17
    • Generic Company Activity 18
    • Market Outlook 19
  • Seretide/Advair (fluticasone propionate+ salmeterol xinafoate) 20
    • Mode of Action 20
    • Approvals 20
    • Patents 21
    • FDA Draft Guidance for Fluticasone Propionate+Salmeterol Xinafoate 22
    • Generic Company Activity 22
    • Teva 22
    • Mylan 23
    • Sandoz 23
    • Cipla 23
    • Market Outlook 24
  • Serevent (salmeterol xinafoate) 25
    • Mode of Action 25
    • Approvals 25
    • Patents 25
    • Generic Company Activity 26
    • Market Outlook 26
  • Ventolin (salbutamol [albuterol]) 27
    • Mode of Action 27
    • Approvals 27
    • Patents 27
    • FDA Draft Guidance for Albuterol Sulfate May Promote Generic Competition in the US 28
    • Market Outlook 29
  • Foradil (formoterol fumarate) 30
    • Mode of Action 30
    • Approvals 30
    • Patents 30
    • Generic Company Activity 31
    • Market Outlook 31
  • Pulmicort (budesonide) 32
    • Mode of Action 32
    • Approvals 32
    • Patents 33
      • Patent Litigation 33
    • Generic Company Activity 34
      • Actavis 34
      • Teva 34
      • Apotex 34
      • Sandoz 35
    • Market Outlook 35
  • Symbicort (budesonide+formoterol) 36
    • Mode of Action 36
    • Approvals 36
    • Patents 36
    • Generic Company Activity 37
    • Market Outlook 38
  • Xopenex (levalbuterol) 39
    • Mode of Action 39
    • Approvals 39
    • Patents 39
    • Generic Company Activity 40
      • Mylan 40
      • Actavis 40
      • Prasco Laboratories 40
      • Teva 41
      • US Generic Approvals 41
    • Market Outlook 41
  • Asmanex Twisthaler (mometasone furoate) 43
    • Mode of Action 43
    • Approvals 43
    • Patents 44
    • Generic Company Activity 44
    • Market Outlook 44
  • Alvesco (ciclesonide) 46
    • Mode of Action 46
    • Approvals 46
    • Patents 46
    • Generic Company Activity 47
    • Market Outlook 47
  • Combivent (ipratropium bromide+ salbutamol [albuterol]) 48
    • Mode of Action 48
    • Approvals 48
    • Patents 48
    • Generic Company Activity 49
    • Market Outlook 49
  • Spiriva (tiotropium bromide) 51
    • Mode of Action 51
    • Approvals 51
    • Lifecycle Development 51
    • Patents 52
    • Generic Company Activity 52
    • Market Outlook 52
  • Brovana (arformoterol tartrate) 54
    • Mode of Action 54
    • Approvals 54
    • Patents 54
    • Patent Infringement Litigation 55
    • Generic Company Activity 55
    • Market Outlook 55
  • Onbrez Breezhaler/Arcapta Neohaler (indacaterol) 57
    • Mode of Action 57
    • Approvals 57
    • Patents 57
    • Market Outlook 58

ALLERGIC RHINITIS 59

  • Market Overview 59
    • Market Leaders 59
    • New Products to Watch 60
    • Approved Generics 61
  • Nasonex (mometasone furoate) 63
    • Mode of Action 63
    • Approvals 63
    • Patents 63
    • Generic Company Activity 64
      • Sandoz 64
      • Apotex 64
    • Market Outlook 64
  • Flixonase/Flonase (fluticasone propionate) 66
    • Mode of Action 66
    • Approvals 66
    • Patents 66
    • Generic Company Activity 66
    • Market Outlook 67
  • Avamys/Veramyst (fluticasone furoate) 69
    • Mode of Action 69
    • Approvals 69
    • Patents 69
    • Generic Company Activity 69
    • Market Outlook 70
  • Rhinocort (budesonide) 71
    • Mode of Action 71
    • Approvals 71
    • Patents 71
    • Generic Company Activity 71
    • Market Outlook 72
  • Nasacort (triamcinolone acetonide) 73
    • Mode of Action 73
    • Approvals 73
    • Patents 74
    • Generic Company Activity 74
    • Market Outlook 74
  • Astelin/Astepro (azelastine hydrochloride) 76
    • Mode of Action 76
    • Approvals 76
    • Patents 76
    • Generic Company Activity 76
    • Market Outlook 77
  • Omnaris (ciclesonide) 79
    • Mode of Action 79
    • Approvals 79
    • Patents 79
    • Generic Company Activity 80
    • Market Outlook 80

GENERIC COMPETITORS 82

  • Actavis 82
    • Respiratory Market Presence 82
      • Budesonide 82
      • Levalbuterol 83
  • Apotex 84
    • Respiratory Market Presence 84
      • Azelastine Hydrochloride 84
      • Pulmicort Respules (budesonide) Litigation 84
  • Cipla 85
    • Respiratory Market Presence 85
  • Mylan 86
    • Respiratory Market Presence 86
      • Perforomist (formoterol fumarate) 86
      • Levalbuterol 86
      • Acquisition of Respiratory Delivery Platform 87
  • Nephron Pharmaceuticals 88
    • Respiratory Market Presence 88
  • Sandoz 89
    • Respiratory Market Presence 89
      • In Development 89
      • Veramyst (fluticasone furoate) Litigation 89
      • Pulmicort Respules (budesonide) Litigation 90
  • Teva Pharmaceutical Industries 91
    • Respiratory Market Presence 91
      • Proair (albutero]) 91
      • Qvar (beclomethasone dipropionate) 91
      • Neovent/Sereflo (salmeterol xinafoate) 92
      • Generics 92

Sources 94

Index 95

List of Tables

  • FDA ANDA Approvals, 2005-2013 7
  • Sales of Leading Inhalable Asthma/COPD Drugs, 2011-2012 (US$ Million) 14
  • US Patent Expiry of Leading Inhalable Asthma/COPD Drugs 14
  • FDA ANDA Approvals for Asthma/COPD Inhalable Drugs, 2003-2013 16
  • Flovent HFA US Patents 18
  • Flovent Diskus US Patents 18
  • Flixotide/Flovent Sales, 2008-2012 (£ & US$ Million) 19
  • Advair HFA US Patents 21
  • Advair Diskus US Patent 21
  • Seretide/Advair Sales, 2008-2012 (£ & US$ Million) 24
  • Serevent US Patents 25
  • Serevent Sales, 2008-2012 (£ & US$ Million) 26
  • Ventolin HFA US Patents 28
  • Ventolin Sales, 2009-2012 (£ & US$ Million) 29
  • Foradil US Patents 30
  • Foradil Sales, 2008-2012 (US$ Million) 31
  • Pulmicort Flexhaler US Patents 33
  • Pulmicort Respules US Patents 33
  • Pulmicort Sales, 2008-2012 (US$ Million) 35
  • Symbicort US Patents 37
  • Symbicort Sales, 2008-2012 (US$ Million) 38
  • Xopenex US Patents 39
  • FDA ANDA Approvals for Levalbuterol Inhalation Solution 41
  • Xopenex Sales, 2008-2012 (¥ Billion & US$ Million) 41
  • Asmanex Twisthaler US Patents 44
  • Asmanex Twisthaler Sales, 2008-2012 (US$ Million) 44
  • Alvesco US Patents 46
  • Alvesco Sales, 2008-2012 (US$ Million) 47
  • Combivent US Patent 48
  • Combivent Respimat US Patents 49
  • Combivent Sales, 2008-2012 (EUR & US$ Million) 50
  • Spiriva US Patents 52
  • Spiriva Sales, 2008-2012 (EUR & US$ Million) 53
  • Brovana Neohaler US Patents 54
  • Brovana Sales, 2008-2012 (US$ Million) 55
  • Arcapta Neohaler US Patents 57
  • Onbrez Breezhaler/Arcapta Neohaler Sales, 2010-2012 (US$ Million) 58
  • Sales of Leading Nasal Spray Allergy Drugs, 2011-2012 (US$ Million) 60
  • US Patent Expiry for Selected Nasal Spray Allergy Drugs 60
  • FDA ANDA Approvals for Allergy Nasal Sprays, 2002-2013 62
  • Nasonex US Patents 64
  • Nasonex Sales, 2008-2012 (US$ Million) 65
  • FDA ANDA Approvals for Fluticasone Propionate Nasal Spray 67
  • Flixonase/Flonase Sales, 2008-2012 (£ & US$ Million) 67
  • Veramyst US Patents 69
  • Avamys/Veramyst Sales, 2008-2012 (£ & US$ Million) 70
  • Product US Patents 71
  • Rhinocort Sales, 2008-2012 (US$ Million) 72
  • Nasacort US Patents 74
  • Nasacort Sales, 2008-2012 (US$ Million) 74
  • Astepro US Patents 76
  • FDA ANDA Approvals for Azelastine Hydrochloride Nasal Spray 77
  • Astelin/Astepro Sales, 2008-2012 (SEK & US$ Million) 78
  • Omnaris US Patents 79
  • Omnaris Sales, 2008-2012 (EUR & US$ Million) 80
  • Actavis ANDA Approvals, 2007-2013 82
  • Nephron Pharmaceuticals ANDA Approvals, 2001-2013 88
  • Teva ANDA Approvals, 2007-2013 93

List of Figures

  • Leading Respiratory Products by Mode of Delivery, 2012 (%) 6
  • Respiratory Market Share by Company, 2012 (%) 6
  • Flixotide/Flovent Sales, 2008-2018 (US$ Million) 19
  • Seretide/Advair Sales, 2008-2018 (US$ Million) 24
  • Serevent Sales, 2008-2018 (US$ Million) 26
  • Ventolin Sales, 2009-2018 (US$ Million) 29
  • Foradil Sales, 2008-2012 (US$ Million) 31
  • Pulmicort Sales, 2008-2018 (US$ Million) 35
  • Symbicort Sales, 2008-2018 (US$ Million) 38
  • Xopenex Sales, 2008-2018 (US$ Million) 42
  • Asmanex Twisthaler Sales, 2008-2018 (US$ Million) 45
  • Combivent Sales, 2008-2012 (US$ Million) 50
  • Spiriva Sales, 2008-2012 (US$ Million) 53
  • Brovana Sales, 2008-2012 (US$ Million) 56
  • Onbrez Breezhaler/Arcapt Neohaler Sales, 2010-2018 (US$ Million) 58
  • Nasonex Sales, 2008-2018 (US$ Million) 65
  • Flixonase/Flonase Sales, 2008-2018 (US$ Million) 68
  • Avamys/Veramyst Sales, 2008-2018 (US$ Million) 70
  • Rhinocort Sales, 2008-2018 (US$ Million) 72
  • Nasacort Sales, 2008-2018 (US$ Million) 75
  • Astelin/Astepro Sales, 2008-2014 (US$ Million) 78
  • Omnaris Sales, 2008-2018 (US$ Million) 81
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