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

Published by: Urch Publishing

Published: Feb. 1, 2007 - 130 Pages


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

Abstract

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


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