Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2010

Date: March 22, 2010
Pages: 128
Price:
US$ 1,740.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: E0F505B0A62EN
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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 (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patent on Seretide/Advair will expire in the US in September 2010 and in most European markets in 2013; the UK patent was revoked. Combination patents covering Symbicort have been revoked in Europe, and AstraZeneca’s data exclusivity will end in August 2010.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 licence 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])

ANAESTHESIA

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
FOREWORD

EXECUTIVE SUMMARY

OVERVIEW


Leading Generic Markets
Inhalation and Nasal Spray Drugs
Asthma & COPD
  Cystic fibrosis
  Allergic rhinitis
  Influenza
  Migraine, pain and other CNS disorders
  Osteoporosis
  Anaesthesia
  Pulmonary arterial hypertension
  Nocturia
  Diabetes
Critical Path Opportunities for Generic Drugs in the US
Market Leaders and Patent Expiry
FDA Approved Generics

ASTHMA & COPD

Flixotide/Flovent (fluticasone propionate)
  Patents
    Market Outlook
Serevent (salmeterol xinafoate)
  Patents
  Market Outlook
Seretide/Advair (salmeterol xinafoate+fluticasone propionate)
  Patents
  Generic Company Activity
    Patent Challenges
    Sandoz/Vectura
  Market Outlook
Pulmicort (budesonide)
  Patents
  Generic Company Activity
    Teva
    Apotex and Watson
  Market Outlook
Symbicort (budesonide+formoterol)
  Patents
  Generic Company Activity
  Market Outlook
Foradil (formoterol)
  Patents
  Market Outlook
Combivent (ipratropium bromide+salbutamol)
  Patents
  Generic Company Activity
  Market Outlook
Xopenex (levalbuterol)
  Patents
  Generic Company Activity
    Breath (Watson)
    Barr (Teva)
    Mylan
  Market Outlook
Spiriva (tiotropium)
  Patents
  Market Outlook

ALLERGIC RHINITIS

Flixonase (fluticasone propionate)
  Generic Competition
  Market Outlook
Rhinocort (budesonide)
  Patents
  Generic Company Activity
  Market Outlook
Nasonex (mometasone furoate)
  Patents
  Generic Company Activity
  Market Outlook
Nasacort (triamcinolone acetonide)
  Patents
  Generic Company Activity
  Market Outlook
Astelin (azelastine hydrochloride)
  Patents
  Generic Company Activity
  Market Outlook

INFLUENZA

Relenza (zanamivir)
Litigation
  Patents
  Generic Company Activity
  Market Outlook

MIGRAINE AND CLUSTER HEADACHE

Imigran (sumatriptan)
  Patents
  Generic Competition
  Market Outlook
Zomig (zolmitriptan)
  Patents
  Market Outlook

OSTEOPOROSIS

Miacalcin (calcitonin-salmon)
Further Development
  Patents
  Generic Company Activity
    Sandoz
    MDRNA/Par Pharmaceutical
    Apotex
  Market Outlook
Fortical (calcitonin-salmon [rDNA origin])
  Patents
Generic Activity

ANAESTHESIA

Ultane (sevoflurane)
  Patents
  Generic Competition
  Market Outlook
Suprane (desflurane)
  Patents
  Generic Competition

COMPANY PROFILES

Apotex
Inhalation and Nasal Spray Products
Baxter Healthcare
Inhalation Products
Financials
Beximco Pharmaceuticals
Products
Financials
Cipla
Products
Development agreement with Akorn
Financials
Hi-Tech Pharmacal
Products
Financials
Hovione FarmaCiencia
Products
Hovione licenses inhaler technology to Sankyo/Biota
Financials
Mylan
Products
Financials
Nephron Pharmaceuticals
Products
Piramal Healthcare
Products
Financials
Acquisitions
Minrad International
RxElite’s inhalation anaesthetic gas distribution business
Ranbaxy
Products
Financials
Roxane Laboratories
Products
Financials
Sandoz
Products
Financials
Teva Pharmaceutical Industries
Products
Asthma & COPD
Allergic Rhinitis
Financials
Watson Pharmaceuticals
Products
Financials
Acquisitions
Eden Biodesign
Arrow Group

SOURCES

Espicom Sources
Others

LIST OF TABLES

US Patent Expiry for Major Inhalation/Nasal Spray Drugs
FDA ANDA Approvals for Inhalation and Nasal Spray Drugs, 2002-2009
US Patent Expiry for Major Asthma and COPD Inhalable Therapies; 2009 Sales (US$ Million)
US FDA Approved Generic Asthma/COPD Inhalation Products
Flixotide/Flovent Sales, 2005-2009 (£ & US$ Million)
Flovent Diskus US Patents
Flovent HFA US Patents
Serevent Sales, 2005-2009 (£ & US$ Million)
Serevent US Patents
Seretide/Advair Sales, 2005-2009 (£ & US$ Million)
Advair US Patents
Pulmicort Sales, 2005-2009 (US$ Million)
Pulmicort US Patents
Symbicort Sales, 2005-2009 (US$ Million)
Symbicort US Patents
Foradil Sales, 2005-2009 (US$ Million)
Foradil US Patents
Foradil Certihaler US Patents
Combivent Sales, 2004-2008 (EUR & US$ Million)
Combivent US Patent
Xopenex Sales, 2004-2008 (US$ Million)
Xopenex US Patents
Spiriva Sales, 2004-2008 (EUR & US$ Million)
Spiriva US Patents
US Patent expiry for Selected Nasal Spray Allergy Therapies; 2009 Sales (US$ Million)
US FDA Approved Generic Allergic Rhinitis Nasal Spray Products
Flixonase/Flonase Sales, 2005-2009 (£ & US$ Million)
Rhinocort Sales, 2005-2009 (US$ Million)
Rhinocort US Patents
Nasonex Sales, 2004-2008 (US$ Million)
Nasonex US Patents
Nasacort Sales, 2005-2009 (EUR & US$ Million)
Nasacort US Patents
Astelin Sales, 2006-2009 (SEK & US$ Million)
Astelin US Patent
Relenza Sales, 2005-2009 (£ & US$ Millions)
Relenza US Patents
Imigran/Imitrex Sales, 2005-2009 (£ & US$ Million)
Imitrex US Patents
Zomig Sales, 2005-2009 (US$ Million)
Zomig US Patents
Miacalcic/Miacalcin Sales, 2003-2007 (US$ Million)
Miacalcin US Patents
Fortical US Patent
Ultane/Sevorane Sales, 2004-2008 (US$ Million)
Ultane US Patents
FDA ANDA Approvals for Sevoflurane
Suprane US Patents
Apotex ANDA Approvals for Inhalable and Nasal Spray Drugs, 2001-2009
Baxter Healthcare ANDA Approvals for Inhalable Drugs
Baxter Financial Results, 2004-2008 (US$ Million)
Beximco Pharmaceuticals Financial Results, 2004-2008
Cipla Financial Results, 2005-2009
Hi-Tech Pharmacal ANDA Approval for Nasal Spray
Hi-Tech Pharmacal Financial Results, 2005-2009 (US$ millions)
Dey ANDA Approvals, 1987-2009
Mylan Sales, 2005-2008 (US$ Million)
Nephron Pharmaceuticals ANDA Approvals, 1997-2007
Minrad International ANDA Approval
Piramal Healthcare: Financial Results, 2005-2009
Ranbaxy Financial Results, 2004-2008
Roxane Laboratories ANDA Approvals for Inhalation and Nasal Spray Products, 2002-2008
Roxane Sales, 2005-2007 (EUR & US$ Million)
Sandoz ANDA Approval for Inhalation Product, 2006
Sandoz financial results, 2004-2008 (US$ Million)
Teva ANDA Approvals for Inhalable products, 2007-2008
Teva Financial Results, 2004-2008 (US$ millions)
Watson ANDA Approvals for Inhalable Products, 2007
Cobalt and Breath ANDA Approvals for Inhalable Products, 2003-2008
Watson Financial Results, 2004-2008 (US$ Million)

LIST OF FIGURES

Generic Pharmaceutical Expenditure, 2009 (US$ Billions)
Generic Pharmaceutical Expenditure per capita, 2009 (US$)
Generic Pharmaceutical Expenditure as % of Total, 2009
FDA ANDA Approvals by Indication, 2002-2009
FDA ANDA Approvals by Indication, 2002-2009 (%)
FDA ANDA Approvals by Company, 2002-2009
Flixotide/Flovent Sales, 2004A-2014E (US$ Million)
Serevent Sales, 2004A-2014E (US$ Million)
Seretide/Advair Sales, 2004A-2014E (US$ Million)
Pulmicort Sales, 2004A-2014E (US$ Million)
Symbicort Sales 2004A-2014E (US$ Million)
Foradil Sales 2004A-2014E (US$ Million)
Combivent Sales, 2004A-2014E (US$ Million)
Xopenex Sales, 2004A-2014E (US$ Million)
Spiriva Sales 2004A-2014E (US$ Million)
Flixonase/Flonase Sales, 2004A-2014E (US$ Million)
Rhinocort Sales, 2004A-2014E (US$ Million)
Nasonex Sales, 2004A-2014E (US$ Million)
Nasacort Sales, 2004A-2014E (US$ Million)
Astelin Sales, 2006A-2014E (US$ Million)
Imigran/Imitrex Sales, 2004A-2014E (US$ Million)
Zomig Sales, 2004A-2014E (US$ Million)
Miacalcin Sales, 2004A-2014E (US$ Million)
Sevoflurane Projected Sales, 2004A-2014E (US$ Million)
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