Summary
“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
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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
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TABLE OF CONTENTS
