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Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs
Espicom Business Intelligence Ltd, Oct 2008, Pages: 122
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 9
Influenza 10
Migraine, pain and other CNS disorders 10
Osteoporosis 12
Anaesthesia 12
Pulmonary arterial hypertension 12
Anthrax 12
Erectile dysfunction 12
Nocturia 12
Diabetes 13
Critical Path Opportunities for Generic Drugs in the US 14
Market Leaders and Patent Expiry 16
FDA Approved Generics 18
Asthma & COPD 22
Flixotide/Flovent (fluticasone propionate) 28
Market Outlook 29
Serevent (salmeterol xinafoate) 30
Patents 30
Market Outlook 31
Seretide/Advair (salmeterol xinafoate+fluticasone propionate) 32
Safety Issues 33
Patents 33
Generic Company Activity 34
Market Outlook 35
Pulmicort (budesonide) 36
Patents 37
Generic Company Activity 37
Market Outlook 38
Symbicort (budesonide+formoterol) 39
Patents 39
Generic Company Activity 40
Market Outlook 40
Combivent (ipratropium bromide+salbutamol) 42
Patents 42
Generic Company Activity 43
Market Outlook 43
Xopenex (levalbuterol) 44
Patents 44
Generic Company Activity 45
Market Outlook 45
Spiriva (tiotropium) 47
Patents 47
Market Outlook 48
Allergic rhinitis 49
Flixonase (fluticasone propionate) 51
Generic Competition 51
Market Outlook 52
Rhinocort (budesonide) 53
Patents 53
Generic Company Activity 54
Market Outlook 54
Nasonex (mometasone furoate) 55
Patents 55
Market Outlook 56
Nasacort (triamcinolone acetonide) 57
Patents 57
Generic Company Activity 58
Market Outlook 58
Astelin (azelastine hydrochloride) 59
Patents 60
Generic Company Activity 60
Market Outlook 60
Influenza 62
Relenza (zanamivir) 63
Litigation 64
Patents 64
Generic Company Activity 64
Market Outlook 65
Migraine and Cluster Headache 66
Imigran (sumatriptan) 67
Patents 68
Generic Competition 68
Market Outlook 69
Zomig (zolmitriptan) 71
Patents 72
Market Outlook 72
Osteoporosis 74
Miacalcin (calcitonin-salmon) 75
Further Development 76
Patents 76
Generic Company Activity 76
Market Outlook 77
Fortical (calcitonin-salmon [rDNA origin]) 78
Patents 78
Generic Activity 78
Anaesthesia 79
Ultane (sevoflurane) 79
Patents 79
Generic Competition 80
Market Outlook 80
Suprane (desflurane) 82
Patents 82
Generic Competition 82
Company Profiles 83
Amphastar Pharmaceuticals 83
Products 83
Apotex 85
Inhalation and Nasal Spray Products 86
Barr Pharmaceuticals 88
Product Development 89
Financials 89
Baxter Healthcare 90
Inhalation Products 90
Financials 91
Beximco Pharmaceuticals 93
Products 93
Financials 94
Cipla 95
Products 95
Development agreement with Akorn 97
Financials 97
Hi-Tech Pharmacal 98
Products 98
Financials 99
Hovione FarmaCiencia 100
Products 100
Hovione licenses inhaler technology to Sankyo/Biota 101
Financials 101
Mylan 102
Products 103
Financials 104
Nephron Pharmaceuticals 105
Products 105
Ranbaxy 106
Products 107
Financials 108
Roxane Laboratories 109
Products 109
Financials 110
RxElite 111
Products 111
Financials 112
Sandoz 113
Products 114
Financials 115
Teva Pharmaceutical Industries 116
Products 116
Asthma & COPD 116
Allergic Rhinitis 117
Financials 117
Watson Pharmaceuticals 119
Products 119
Financials 120
SOURCES 121
Espicom Sources 121
Others 121
List of Tables
US Patent Expiry for Major Inhalation/Nasal Spray Drugs 17
FDA ANDA Approvals for Inhalation and Nasal Spray Drugs, 2000-2008 20
US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2007 Sales (US$ Million) 24
US FDA Approved Generic Asthma/COPD Inhalation Products 26
Flixotide/Flovent Sales, 2003-2007 (£ & US$ Million) 28
Serevent Sales, 2003-2007 (£ & US$ Million) 30
Serevent US Patents 31
Seretide/Advair Sales, 2003-2007 (£ & US$ Million) 32
Advair US Patents 34
Pulmicort Sales, 2003-2007 (US$ Million) 36
Pulmicort US Patents 37
Symbicort Sales, 2003-2007 (US$ Million) 39
Symbicort US Patents 40
Combivent Sales, 2003-2007 (EUR & US$ Million) 42
Combivent US Patent 42
Xopenex Sales, 2003-2007 (US$ Million) 44
Xopenex US Patents 45
Spiriva Sales, 2003-2007 (EUR & US$ Million) 47
Spiriva US Patents 48
US Patent expiry for Selected Nasal Spray Allergy Therapies; 2007 Sales (US$ Million) 50
US FDA Approved Generic Allergic Rhinitis Nasal Spray Products 50
Flixonase/Flonase Sales, 2003-2007 (£ & US$ Million) 51
Rhinocort Sales, 2003-2007 (US$ Million) 53
Rhinocort US Patents 53
Nasonex Sales, 2003-2007 (US$ Million) 55
Nasonex US Patents 56
Nasacort Sales, 2003-2007 (EUR & US$ Million) 57
Nasacort US Patents 57
Astelin Sales, 2006-2007 (SEK & US$ Million) 59
Astelin US Patent 60
Relenza Sales, 2005-2007 (£ & US$ Millions) 63
Relenza US Patents 64
Imigran/Imitrex Sales, 2003-2007 (£ & US$ Million) 67
Imitrex US Patents 68
Zomig Sales, 2003-2007 (US$ Million) 71
Zomig US Patents 72
Miacalcic/Miacalcin Sales, 2003-2007 (US$ Million) 75
Miacalcin US Patents 76
Fortical US Patent 78
Ultane/Sevorane Sales, 2003-2007 (US$ Million) 79
Ultane US Patents 80
FDA ANDA Approvals for Sevoflurane 80
Suprane US Patents 82
Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2007 87
Financial Results, 2006-07 (US$ million) 89
Baxter Healthcare ANDA Approvals for Inhalable Drugs 91
Baxter Financial Results, 2003-2007 (US$ Million) 92
Beximco Pharmaceuticals Financial Results, 2004-2007 94
Cipla: Financial Results, 2003-2007 97
Hi-Tech Pharmacal ANDA Approval for Nasal Spray 98
Hi-Tech Pharmacal Financial Results, 2005-2008 (US$ millions) 99
Dey ANDA Approvals, 1987-2008 104
Dey Tentative ANDA Approvals for Inhalation Products 104
Nephron Pharmaceuticals ANDA Approvals, 1997-2007 105
Ranbaxy Financial Results, 2003-2007 108
Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray Products, 2002-2008 110
Roxane Sales, 2005-2007 (EUR & US$ Million) 110
RxElite ANDA Approvals for Inhalation Products 111
Financial Results, 2006-2007 (US$ Million) 112
Sandoz ANDA Approval for Inhalation Product, 2006 115
Sandoz financial results, 2003-2007 (US$ Million) 115
Teva ANDA Approval for Inhalable product, 2007 117
Teva Financial Results, 2003-2007 (US$ millions) 118
Watson ANDA Approvals for Inhalable Products, 2007 120
Watson Financial Results, 2003-2007 (US$ Million) 120
List of Figures
Generic Pharmaceutical Expenditure, 2007 (US$ billions) 5
Generic Pharmaceutical Expenditure per capita, 2007 (US$) 6
Generic Pharmaceutical Expenditure as % of Total, 2007 7
FDA ANDA Approvals by Therapeutic Area, 2002-2008 18
FDA ANDA Approvals by Therapeutic Area, 2002-2008 (%) 19
FDA ANDA Approvals by Company, 2002-2008 19
Flixotide/Flovent Sales, 2003A-2013E (US$ Million) 29
Serevent Sales, 2003A-2013E (US$ Million) 31
Seretide/Advair Sales, 2003A-2013E (US$ Million) 35
Pulmicort Sales, 2003A-2013E (US$ Million) 38
Symbicort Sales 2003A-2013E (US$ Million) 41
Combivent Sales, 2003A-2013E (US$ Million) 43
Xopenex Sales, 2003A-2013E (US$ Million) 46
Spiriva Sales 2003A-2013E (US$ Million) 48
Flixonase/Flonase Sales, 2003A-2013E (US$ Million) 52
Rhinocort Sales, 2003A-2013 (US$ Million) 54
Nasonex Sales, 2003A-2013E (US$ Million) 56
Nasacort Sales, 2003A-2013E (US$ Million) 58
Astelin Sales, 2006A-2013E (US$ Million) 61
Imigran/Imitrex Sales, 2003A-2013E (US$ Million) 70
Zomig Sales, 2003A-2013E (US$ Million) 73
Miacalcin Sales, 2003A-2013E (US$ Million) 77
Sevoflurane Projected Sales, 2008-2013 (US$ Million) 81
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