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Generic Drugs


Generic Competition, 2007–11

The impact of patent expiries on sales of major drugs

Publication Date   February 2007
Publisher   URCH Publishing
Product Type   Report
Pages   130
ISBN Number   978-1-905751-01-3
Product Code   URC153
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Summary


Generic Competition 2007 to 2011: The impact of patent expiries on sales of major drugs is a 50,000 word report that provides the valuable market data and insight that both ethical and generic pharmaceutical companies will find useful in their business.

This unique report will describe in detail which major selling drugs will be affected by patent expiry and the likely financial effect on the producer company. The following information for each drug is provided:
- Indication
- Manufacturer
- Revenues ($m) for 2001–06 (total and US)
- % of company’s 2005 revenues
- Share of market segment
- Key competitors
- Patent Status in US, France, Germany, Italy and UK
- Patenting activity by generics companies
- Generic regulatory filing activity
- Pending litigation issues
- Share of market segment
- Impact of generic substitutes:
Directly on distributor
Indirectly on competitors
On market segment
Distributor(s)
Franchise defence strategies

Key features of this report

  • Reviews of over 50 major drugs that will come off patent between 2007 and 2011
  • Listing of generic regulatory filing activity
  • Solid overview of market for generic drugs over the next four years
  • Global product sales figures for years 2001-2005 with share by company revenue & market segment

    Use this report to:

  • Forecast the market share that will be lost to generic competition
  • Understand which global companies are under pressure from generics
  • Consider the effect of expiry on the patent holder’s competitors
  • See whether there are any outstanding litigation issues
  • Learn which generic companies are active in filing

  • Content


    Chapter 1: The Impact of Patent Expiries, 2007–11
    Introduction
    Patent expiry by date
    Major generics companies
    Overview
    Europe
    Ratiopharm
    Sandoz
    Merck KGaA
    Actavis
    Schwarz Pharma
    Stada Arzneimittel
    North America
    Apotex
    Barr
    Mylan
    Watson
    Asia
    Teva
    Ranbaxy
    Dr Reddy’s

    Chapter 2: Historical and Legal Context of Generic Drugs
    Impact of generics on revenue
    National factors
    Prozac
    Plavix
    Patent regulations
    Europe
    US
    Hatch–Waxman
    ANDA process

    Chapter 3: Generic Biotechnology Products (Biosimilars)
    Introduction
    Biosimilars
    Entry barriers
    Major legal cases
    Potential biogenerics by 2011
    Legal status
    Europe
    US

    Chapter 4: Major Generic Opportunities
    Overview
    Plavix
    Advair
    Lipitor

    Chapter 5: Impact of Patent Expiry on Key Ethical Pharma Companies
    Introduction
    Abbott
    Amgen
    Astellas
    AstraZeneca
    Bayer-Schering
    Boehringer Ingelheim
    Bristol-Myers Squibb
    Daiichi Sankyo
    Eli Lilly
    GlaxoSmithKline
    Johnson & Johnson
    Merck & Co.
    Merck KGaA
    Novartis
    Pfizer
    Roche
    Sanofi-Aventis
    Schering-Plough
    Takeda
    Wyeth

    Chapter 6: Patent Expiries in 2007
    Overview
    Major patent expiries in Europe
    Major patent expiries in the US
    Potential revenue loss
    Review of drugs with 2007 US patent expiries
    Terbinafine (Lamisil)
    Acarbose (Glucobay/Precose)
    Carvedilol (Coreg/Dilatrend)
    Amlodipine besylate and benazepril hydrochloride (Lotrel)
    Finasteride (Proscar/Propecia)
    Sumatriptan (Imigran/Imitrex)
    Amlodipine besylate (Norvasc)
    Desloratadine (Clarinex)
    Esomeprazole (Nexium)
    Oxycodone hydrochloride (OxyContin)
    Modafinil (Provigil)
    Cetirizine hydrochloride (Zyrtec)
    Granisetron hydrochloride (Kytril)
    Risperidone(Risperdal)

    Chapter 7: Patent Expiries in 2008 Overview
    Major patent expiries in Europe
    Major patent expiries in the US
    Potential revenue loss
    Review of drugs with 2008 US patent expiries
    Sodium alendronate (Fosamax/Bonalon)
    Divalproex sodium (Depakote/Depakine/Depakene)
    Salmeterol xinafoate plus fluticasone propionate (Advair/Seretide)
    Irinotecan hydrochloride (Camptosar/Campto/Topotecin)
    Venlafaxine (Effexor)
    Levetiracetam (Keppra)
    Lamotrigine (Lamictal)
    Salmeterol xinafoate (Serevent)
    Topiramate hydrochloride (Topamax)
    Bicalutamide (Casodex)

    Chapter 8: Patent Expiries in 2009 Overview
    Major patent expiries in Europe
    Major patent expiries in the US
    Potential revenue loss
    Review of drugs with 2009 US patent expiries
    Lansoprazole (Prevacid/Takepron/Zoton)
    Duloxetine (Cymbalta/XeriStar)
    Tamsulosin hydrochloride (Flomax/Omnic/Harnal)
    Perindopril erbumine (Coversyl/Aceon)
    Escitalopram oxalate (Lexapro/Cipralex)
    Anastrozole (Arimidex)

    Chapter 9: Patent Expiries in 2010
    Overview
    Major patent expiries in Europe
    Major patent expiries in the US
    Potential revenue loss
    Review of drugs with 2010 US patent expiries
    Losartan potassium (Cozaar/Hyzaar)
    Atorvastatin calcium (Lipitor)
    Docetaxel (Taxotere)
    Gemcitabine hydrochloride (Gemzar)
    Lamivudine and zidovudine (Combivir)
    Pantoprazole (Protonix/Pantozol)
    Donepezil hydrochloride (Aricept)
    Anastrozole (Arimidex)
    Levofloxacin (Levaquin/Cravit/Tavanec)

    Chapter 10: Patent Expiries in 2011
    Overview
    Major patent expiries in Europe
    Major patent expiries in the US
    Potential revenue loss
    Review of drugs with 2011 US patent expiries
    Pioglitazone hydrochloride (Actos)
    Latanoprost (Xalatan/Xalcom)
    Pramipexole dihydrochloride (Sifrol/Mirapex)
    Letrozole (Femara)
    Pemetrexed disodium (Alimta)
    Olanzapine (Zyprexa)
    Quetiapine fumarate (Seroquel)
    Clopidogrel bisulphate (Plavix)
    Goserelin acetate (Zoladex)
    Moxifloxacin hydrochloride (Avelox)

    List of Figures

    Figure 1.1 2005 revenues in the US for drugs going off patent in the year indicated
    Figure 1.2 Number of potential generic market entries in the US, 2007–11
    Figure 1.3 Number of potential generics market entries in France, Germany and the UK, 2007–11
    Figure 2.1 European generics industry showing respective market shares by value and volume in each of the five major European markets
    Figure 2.2 US sales of Prozac and generic fluoxetine, 2000–05
    Figure 2.3 Quarterly US sales of Plavix, 2004–06 (the figure for Q4 2006 is estimated)
    Figure 5.1 Potential exposure of the 20 leading pharmaceutical companies’ revenues to generic competition, 2007–11
    Figure 5.2 Potential exposure of the US revenues of the 20 leading pharmaceutical companies to generic competition by year in the period 2007–11
    Figure 5.3 Expiry dates of key US drug patents by year in the period 2007–11 for the 20 leading pharmaceutical companies
    Figure 6.1 US revenues at risk from patent expirations during 2007
    Figure 7.1 US revenues at risk from patent expirations during 2008
    Figure 8.1 US revenues at risk from patent expirations during 2009
    Figure 9.1 US revenues at risk from patent expirations during 2010
    Figure 10.1 US revenues at risk from patent expirations during 2011

    List of Tables

    Table 1.1 Leading generics companies, 2005 pro forma revenues allowing for recent acquisitions
    Table 3.1 Leading biotechnology therapeutics showing reported global sales for 2004 and 2005
    Table 4.1 The world’s best-selling drugs in 2005
    Table 5.1 AstraZeneca products facing generic threats, 2007–11
    Table 5.2 Eli Lilly products facing generic threats, 2007–11
    Table 5.3 GlaxoSmithKline products facing generic threats, 2007–11
    Table 5.4 Johnson & Johnson products facing generic threats, 2007–11
    Table 5.5 Merck products facing generic threats, 2007–11
    Table 5.6 Novartis products facing generic threats, 2007–11
    Table 5.7 Pfizer products facing generic threats, 2007–11
    Table 6.1 Major drugs whose patents expire in France, Germany and/or the UK in 2007
    Table 6.2 Major drugs whose patent protection and marketing exclusivity expires in the US in 2007
    Table 7.1 Major drugs whose patents expire in France, Germany and/or the UK in 2008
    Table 7.2 Major drugs whose patent protection and marketing exclusivity expires in the US in 2008
    Table 8.1 Significant drugs whose patents will expire in France, Germany and/or the UK in 2009
    Table 8.2 Significant drugs whose patent protection and marketing exclusivity will expire in the US in 2009
    Table 9.1 Significant drugs whose patents will expire in France, Germany and/or the UK in 2010
    Table 9.2 Significant drugs whose patent protection and marketing exclusivity will expire in the US in 2010
    Table 10.1 Significant drugs whose patents will expire in France, Germany and/or the UK in 2011
    Table 10.2 Significant drugs whose patent protection and marketing exclusivity will expire in the US in 2011