Generic Competition 2007 to 2011: The impact of patent expiries on sales of major drugs

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
  • 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