2007年から2011年までのジェネリック医薬品競合動向：特許の失効が及ぼす主要薬剤売上への影響

Abstract

“The period 2007 to 2011 will see the expiration of patent protection for 52 major drugs in the United States, an average of ten a year. With 2005 seeing a decline in the number of NCEs approved down to 18 from 23 in 2004, there is clear evidence that the loss of revenue from patent protected drugs will impact upon the growth of the industry when so few new drugs are reaching the market.”

New generics in the period 2007 to 2011 threaten $100 billion of revenues generated in the United States and Europe. The most dramatic change in this period will arise in the period 2010 to 2012 as the patents covering Lipitor expire.

The loss of revenues to generic substitutes is a major influence on the financial performance of ethical R&D companies. Conversely the successful identification and exploitation of the opportunities afforded by patent expirations provides a major growth driver for the pharmaceutical companies who focus their business on the provision of generic therapeutics.

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

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