Reportlinker Adds Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2010

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

http://www.reportlinker.com/p0185991/Emerging-Opportunities-in-Inhalation--Nasal-Spray-Generic-Drugs-2010.html

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patent on Seretide/Advair will expire in the US in September 2010 and in most European markets in 2013; the UK patent was revoked. Combination patents covering Symbicort have been revoked in Europe, and AstraZeneca's data exclusivity will end in August 2010.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

To order this report:

Generic Drug Industry: Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2010

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