Table of Contents
Executive Summary
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
- Asia
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
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
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