NEW YORK, April 6 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2010
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 pounds Sterling (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patent on Seretide/Advair will expire in the US in September 2010 and in most European markets in 2013; the UK patent was revoked. Combination patents covering Symbicort have been revoked in Europe, and AstraZeneca's data exclusivity will end in August 2010.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.
Moving forward, a greater commitment to development will be required for success in this market
The drive for profit favours higher margin products
The generic market is undergoing radical restructuring, with much rationalisation of the corporate landscape. In such a competitive environment, 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.
Effective drug delivery is a critical opportunity area
Metered dose inhalers (MDIs) that used ozone-depleting chlorofluorocarbon (CFC) propellants were entirely phased-out of the US market at the end of 2008. As yet, generic versions of the more ozone-friendly hydrofluoroalkane (HFA) inhalers that replaced the branded MDIs are not available in the US. Asthma generics currently available in the US are generally inhalation solutions for delivery via a nebuliser rather than hand-held inhalers. Interestingly, the phasing-out of CFC-containing MDIs has also resulted in GSK's Ventolin (salbutamol [albuterol in the US]) re-gaining market exclusivity in the US and achieving sales growth of more than 100% in that market in 2009.
AstraZeneca & Teva: is collaborative working the better way forward?
The number of patent challenges suggests the opportunities for generic inhalation and nasal spray drugs are worth pursuing, even if this results in lengthy legal battles. A case in point concerns Pulmicort.
Teva began its challenge against AstraZeneca's patents for Pulmicort Respules (budesonide inhalation suspension) in 2005, when the company filed an ANDA with Paragraph IV certification. After several years of claims of ongoing litigation, the FDA granted Teva final approval for its ANDA for its generic version in November 2008. The product was immediately launched, as was an authorised generic from Par Pharmaceutical, only to be quickly suspended by a temporary restraining order. The result of a hearing some days later was a settlement whereby Teva could begin selling its generic in December 2009 under an exclusive license from AstraZeneca, under which the latter will receive significant royalties. The agreement between AstraZeneca and Par for an authorised generic was discontinued. Consequently, Teva launched its generic budesonide inhalation solution in the US in December 2009. Apotex, which also has FDA approval for budesonide inhalation solution, is unable to launch its product following a restraining order granted in June 2009.
Questions, Questions...
What are Sandoz/Vectura's interest in GSK's leading Seretide/Advair COPD treatment?
How might Hovione's novel drug delivery technology affect the future market for inhaled influenza treatments?
Who is challenging Schering-Plough's Nasonex patents?
How is Gilead Sciences supporting sales of the cystic fibrosis drug Caytron for which it received approval in February 2010?
THERAPY AREAS AND PRODUCTS ASSESSED
ASTHMA & COPD
Flixotide/Flovent (fluticasone propionate)
Serevent (salmeterol xinafoate)
Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
Pulmicort (budesonide)
Symbicort (budesonide+formoterol)
Combivent (ipratropium bromide+salbutamol)
Xopenex (levalbuterol)
Spiriva (tiotropium)
ALLERGIC RHINITIS
Flixonase (fluticasone propionate)
Rhinocort (budesonide)
Nasonex (mometasone furoate)
Nasacort (triamcinolone acetonide)
Astelin (azelastine hydrochloride)
INFLUENZA
Relenza (zanamivir)
MIGRAINE & CLUSTER HEADACHE
Imigran (sumatriptan)
Zomig (zolmitriptan)
OSTEOPOROSIS
Miacalcin (calcitonin-salmon)
Fortical (calcitonin-salmon [rDNA origin])
ANESTHESIA
Ultane (sevoflurane)
Suprane (desflurane)
COMPANIES EVALUATED
Apotex
Baxter Healthcare
Beximco Pharmaceuticals
Cipla
Hi-Tech Pharmacal
Hovione FarmaCiencia
Mylan
Nephron Pharmaceuticals
Piramal Healthcare
Ranbaxy
Roxane Laboratories
Sandoz
Teva Pharmaceutical Industries
Watson Pharmaceuticals
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. Among her reports are the first edition of this report, plus
Injectable Generic Drugs: Prospects and Opportunities to 2014
Emerging Opportunities in Controlled-Release Generic Drugs
Diabetes Drug Discoveries: what the future holds
The Indian Pharmaceutical Industry: Expansion & Ambitions
Contents
Foreword .... 1
Executive Summary . 3
Overview .... 5
Leading Generic Markets ..... 5
Inhalation and Nasal Spray Drugs 8
Asthma and COPD ........... 8
Cystic fibrosis .......... 9
Allergic rhinitis .... 10
Influenza ... 10
Migraine, pain and other CNS disorders ..... 11
Osteoporosis ........ 13
Anesthesia ......... 13
Pulmonary arterial hypertension ..... 13
Nocturia .... 13
Diabetes .... 14
Critical Path Opportunities for Generic Drugs in the US .... 15
Market Leaders and Patent Expiry .. 17
FDA Approved Generics ......... 19
Asthma & COPD .... 24
Flixotide/Flovent (fluticasone propionate) . 28
Patents ...... 29
Market Outlook ......... 30
Serevent (salmeterol xinafoate) . 32
Patents ...... 33
Market Outlook ......... 33
Seretide/Advair (salmeterol xinafoate+fluticasone propionate) ....... 34
Patents ...... 35
Generic Company Activity ........... 36
Patent Challenges ......... 36
Sandoz/Vectura .. 37
Market Outlook ......... 38
Pulmicort (budesonide) ..... 39
Patents ...... 40
Generic Company Activity ........... 41
Teva .... 41
Apotex and Watson ...... 42
Market Outlook ......... 42
Symbicort (budesonide+formoterol) ... 43
Patents ...... 43
Generic Company Activity ........... 44
Market Outlook ......... 45
Foradil (formoterol) . 46
Patents ...... 46
Market Outlook ......... 47
Combivent (ipratropium bromide+salbutamol) ... 48
Patents ...... 48
Generic Company Activity ........... 49
Market Outlook ......... 49
Xopenex (levalbuterol) ....... 50
Patents ...... 51
Generic Company Activity ........... 51
Breath (Watson) . 51
Barr (Teva) 51
Mylan . 52
Market Outlook ......... 52
Spiriva (tiotropium) . 54
Patents ...... 55
Market Outlook ......... 55
Allergic Rhinitis .... 56
Flixonase (fluticasone propionate) ........ 58
Generic Competition .......... 58
Market Outlook ......... 59
Rhinocort (budesonide) ..... 60
Patents ...... 60
Generic Company Activity ........... 61
Market Outlook ......... 61
Nasonex (mometasone furoate) 62
Patents ...... 62
Generic Company Activity ........... 63
Market Outlook ......... 63
Nasacort (triamcinolone acetonide) ...... 65
Patents ...... 65
Generic Company Activity ........... 66
Market Outlook ......... 66
Astelin (azelastine hydrochloride) .......... 67
Patents ...... 68
Generic Company Activity ........... 68
Market Outlook ......... 68
Influenza .. 70
Relenza (zanamivir) . 71
Litigation .. 72
Patents ...... 72
Generic Company Activity ........... 72
Market Outlook ......... 73
Migraine and Cluster Headache ........... 74
Imigran (sumatriptan) ........ 75
Patents ...... 76
Generic Competition .......... 76
Market Outlook ......... 77
Zomig (zolmitriptan) ........... 78
Patents ...... 78
Market Outlook ......... 79
Osteoporosis ......... 80
Miacalcin (calcitonin-salmon) ..... 81
Further Development ........ 82
Patents ...... 82
Generic Company Activity ........... 82
Sandoz ....... 82
MDRNA/Par Pharmaceutical . 82
Apotex ....... 83
Market Outlook ......... 83
Fortical (calcitonin-salmon [rDNA origin]) ... 84
Patents ...... 84
Generic Activity ......... 84
Anesthesia ........... 85
Ultane (sevoflurane) 85
Patents ...... 85
Generic Competition .......... 86
Market Outlook ......... 87
Suprane (desflurane) .......... 88
Patents ...... 88
Generic Competition .......... 88
Company Profiles .. 89
Apotex ... 89
Inhalation and Nasal Spray Products ...... 90
Baxter Healthcare ..... 92
Inhalation Products ...... 92
Financials .. 93
Beximco Pharmaceuticals . 94
Products .... 94
Financials .. 95
Cipla ....... 96
Products .... 96
Development agreement with Akorn . 98
Financials .. 98
Hi-Tech Pharmacal .100
Products ..100
Financials 101
Hovione FarmaCiencia .....102
Products ..102
Hovione licenses inhaler technology to Sankyo/Biota ........... 103
Financials 103
Mylan ...104
Products ..105
Financials 106
Nephron Pharmaceuticals ..........108
Products ..108
Piramal Healthcare .109
Products ..110
Financials 110
Acquisitions .......111
Minrad International ........ 111
RxElite's inhalation anesthetic gas distribution business .... 112
Ranbaxy ..........113
Products 113
Financials ...... 114
Roxane Laboratories .........115
Products ..115
Financials 116
Sandoz .117
Products ..118
Financials 119
Teva Pharmaceutical Industries 120
Products .. 120
Asthma & COPD ........... 120
Allergic Rhinitis . 122
Financials 122
Watson Pharmaceuticals . 124
Products .. 124
Financials 125
Acquisitions ....... 126
Eden Biodesign ...... 126
Arrow Group 126
SOURCES 128
Espicom Sources ..... 128
Others .. 128
List of Tables
US Patent Expiry for Major Inhalation/Nasal Spray Drugs ........ 18
FDA ANDA Approvals for Inhalation and Nasal Spray Drugs, 2002-2009 ... 22
US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2009 Sales (US$ Million) ...... 25
US FDA Approved Generic Asthma/COPD Inhalation Products ......... 26
Flixotide/Flovent Sales, 2005-2009 (pounds Sterling & US$ Million) ...... 28
Flovent Diskus US Patents 29
Flovent HFA US Patents ..... 30
Serevent Sales, 2005-2009 (pounds Sterling & US$ Million) ........... 32
Serevent US Patents 33
Seretide/Advair Sales, 2005-2009 (pounds Sterling & US$ Million) ......... 34
Advair US Patents ..... 36
Pulmicort Sales, 2005-2009 (US$ Million) .... 39
Pulmicort US Patents .......... 40
Symbicort Sales, 2005-2009 (US$ Million) ... 43
Symbicort US Patents ......... 44
Foradil Sales, 2005-2009 (US$ Million) .. 46
Foradil US Patents .... 47
Foradil Certihaler US Patents ....... 47
Combivent Sales, 2004-2008 (EUR & US$ Million) 48
Combivent US Patent ......... 48
Xopenex Sales, 2004-2008 (US$ Million) ...... 50
Xopenex US Patents 51
Spiriva Sales, 2004-2008 (EUR & US$ Million) ......... 54
Spiriva US Patents .... 55
US Patent expiry for Selected Nasal Spray Allergy Therapies; 2009 Sales (US$ Million) ....... 57
US FDA Approved Generic Allergic Rhinitis Nasal Spray Products ... 57
Flixonase/Flonase Sales, 2005-2009 (pounds Sterling & US$ Million) .... 58
Rhinocort Sales, 2005-2009 (US$ Million) .... 60
Rhinocort US Patents .......... 60
Nasonex Sales, 2004-2008 (US$ Million) ....... 62
Nasonex US Patents 63
Nasacort Sales, 2005-2009 (EUR & US$ Million) ..... 65
Nasacort US Patents 65
Astelin Sales, 2006-2009 (SEK & US$ Million) .......... 67
Astelin US Patent ...... 68
Relenza Sales, 2005-2009 (pounds Sterling & US$ Millions) ........... 71
Relenza US Patents .. 72
Imigran/Imitrex Sales, 2005-2009 (pounds Sterling & US$ Million) ........ 75
Imitrex US Patents .... 76
Zomig Sales, 2005-2009 (US$ Million) .. 78
Zomig US Patents ..... 79
Miacalcic/Miacalcin Sales, 2003-2007 (US$ Million) ........ 81
Miacalcin US Patents ........... 82
Fortical US Patent ..... 84
Ultane/Sevorane Sales, 2004-2008 (US$ Million) .. 85
Ultane US Patents ..... 86
FDA ANDA Approvals for Sevoflurane .. 86
Suprane US Patents . 88
Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2009 ....... 91
Baxter Healthcare ANDA Approvals for Inhalable Drugs .......... 93
Baxter Financial Results, 2004-2008 (US$ Million) ........... 93
Beximco Pharmaceuticals Financial Results, 2004-2008 ........... 95
Cipla Financial Results, 2005-2009 ......... 99
Hi-Tech Pharmacal ANDA Approval for Nasal Spray ..... 100
Hi-Tech Pharmacal Financial Results, 2005-2009 (US$ millions) ...... 101
Dey ANDA Approvals, 1987-2009 ........ 106
Mylan Sales, 2005-2008 (US$ Million) .. 107
Nephron Pharmaceuticals ANDA Approvals, 1997-2007 ........ 108
Minrad International ANDA Approval . 110
Piramal Healthcare: Financial Results, 2005-2009 .......... 111
Ranbaxy Financial Results, 2004-2008 114
Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray Products, 2002-2008 ..... 115
Roxane Sales, 2005-2007 (EUR & US$ Million) ...... 116
Sandoz ANDA Approval for Inhalation Product, 2006 . 119
Sandoz financial results, 2004-2008 (US$ Million) ......... 119
Teva ANDA Approvals for Inhalable products, 2007-2008 ..... 122
Teva Financial Results, 2004-2008 (US$ millions) ..... ...... 123
Watson ANDA Approvals for Inhalable Products, 2007 ........... 125
Cobalt and Breath ANDA Approvals for Inhalable Products, 2003-2008 .. 125
Watson Financial Results, 2004-2008 (US$ Million) ....... 126
List of Figures
Generic Pharmaceutical Expenditure, 2009 (US$ Billions) ........... 5
Generic Pharmaceutical Expenditure per capita, 2009 (US$) ..... 6
Generic Pharmaceutical Expenditure as % of Total, 2009 7
FDA ANDA Approvals by Indication, 2002-2009 ... 19
FDA ANDA Approvals by Indication, 2002-2009 (%) ....... 20
FDA ANDA Approvals by Company, 2002-2009 ... 21
Flixotide/Flovent Sales, 2004A-2014E (US$ Million) ........ 31
Serevent Sales, 2004A-2014E (US$ Million) . 33
Seretide/Advair Sales, 2004A-2014E (US$ Million) ........... 38
Pulmicort Sales, 2004A-2014E (US$ Million) ........... 42
Symbicort Sales 2004A-2014E (US$ Million) ........... 45
Foradil Sales 2004A-2014E (US$ Million) ...... 47
Combivent Sales, 2004A-2014E (US$ Million) ........ 49
Xopenex Sales, 2004A-2014E (US$ Million) . 53
Spiriva Sales 2004A-2014E (US$ Million) ...... 55
Flixonase/Flonase Sales, 2004A-2014E (US$ Million) ...... 59
Rhinocort Sales, 2004A-2014E (US$ Million) ........... 61
Nasonex Sales, 2004A-2014E (US$ Million) . 64
Nasacort Sales, 2004A-2014E (US$ Million) . 66
Astelin Sales, 2006A-2014E (US$ Million) ..... 69
Imigran/Imitrex Sales, 2004A-2014E (US$ Million) ........... 77
Zomig Sales, 2004A-2014E (US$ Million) ..... 79
Miacalcin Sales, 2004A-2014E (US$ Million) 83
Sevoflurane Projected Sales, 2004A-2014E (US$ Million) ......... 87
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