Inhalation & Nasal Spray Generic Drugs 2013

  • November 2013
  • -
  • Espicom Business Intelligence
  • -
  • 106 pages

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. The current market leader overall is GlaxoSmithKline’s Seretide/Advair (fluticasone propionate+salmeterol xianfoate), with sales of US$8.0 billion. Boehringer Ingelheim’s leading COPD therapy, Spiriva (tiotropium bromide) achieved sales of US$4.6 billion. In third place was AstraZeneca’s Symbicort (budesonide+formoterol), with sales of US$3.2 billion. In the allergy segment, the leading nasal spray therapy used in the treatment of allergic rhinitis is Merck & Co’s Nasonex (mometasone furoate), with sales of US$1.3 billion in 2012.

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.

While there have been some generic approvals in Europe, the US market for generic MDIs has been virtually non-existent since the CFC ban was enforced at the end of December 2008. However, this may be about to change. In April 2013, the FDA posted its first individual product guidance for an MDI, for albuterol sulphate. This was followed in September 2013 by product guidance for fluticasone+salmeterol combination. Not only has the FDA’s Office of Generic Drugs produced guidance that outlines the process by which a bioequivalent generic version of GSK’s Advair may be developed for the US market; it has also made it possible for companies to hold pre-ANDA meetings, to help to resolve complex issues prior to submission. While significant technological barriers remain, with positive backing from the FDA, it may at last be possible for companies to demonstrate
bioequivalence in hand-held, metered dose inhalers.

Teva recently suggested that the first bioequivalent Advair generic is unlikely to be available before 2018. In the meantime, Teva is developing a proprietary combination in a different dosage and in the company’s own delivery device. Teva has also disclosed an intention to launch a bioequivalent generic. While it may yet be five years before a generic approval proves to be possible, the new FDA guidance is likely to promote competition among those companies with the expertise to develop
complex inhalable generics. With three known potential generic versions of Advair in development, it will be interesting to see how long it will be before any of these reach the market, and whether or not they will be able to gain significant market share from GSK.

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 and 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 (£ and US$ Million) 19
Advair HFA US Patents 21
Advair Diskus US Patent 21
Seretide/Advair Sales, 2008-2012 (£ and US$ Million) 24
Serevent US Patents 25
Serevent Sales, 2008-2012 (£ and US$ Million) 26
Ventolin HFA US Patents 28
Ventolin Sales, 2009-2012 (£ and 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 (Â¥ Billion and 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 and US$ Million) 50
Spiriva US Patents 52
Spiriva Sales, 2008-2012 (EUR and 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 (£ and US$ Million) 67
Veramyst US Patents 69
Avamys/Veramyst Sales, 2008-2012 (£ and 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 and US$ Million) 78
Omnaris US Patents 79
Omnaris Sales, 2008-2012 (EUR and US$ Million) 80
Actavis ANDA Approvals, 2007-2013 82
Nephron Pharmaceuticals ANDA Approvals, 2001-2013 88
Teva ANDA Approvals, 2007-2013 93

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