Generic Competition to 2009

Once patent protection and periods of marketing exclusivity expire for a branded drug, sales tend to decline dramatically as generic substitutes capture market share.

Patent expiration for a major product can see revenues for the supplier fall ten-fold within two years. The loss of patent protection for key products is increasingly significant in assessing the future performance of major pharmaceutical companies. The decline of revenues to generic substitutes is a major influence on the financial performance of such 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 to 2009 provides the concise and accurate overview of forthcoming generic competition.

Key features of this report

• Reviews of over 40 major drugs that will come off patent btweeen 2005 and 2006
• Listing of generic regulatory filing activity
• Solid overview of market for generic drugs over the next four years
• Global product sales figures for years 2000-2004 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

• Executive Summary
• 1. The Impact of Patent Expiries 2005-2009
  • Introduction
  • Patent Expiry by date
  • Major Companies
  • Major Generic Companies
  • Europe
  • Sandoz
  • Merck KGaA
  • Schwarz Pharma
  • North America
  • Israel & India
• 2. Historical and Legal Context
  • Impact of generics on revenue
  • National factors
  • Prozac
  • Patent Regulations
  • Europe
  • United States
  • Hatch-Waxmax
  • ANDA process
• 3. Generic Biotechnology Products
  • Introduction
  • Procrit/Epogen
  • NeoRecormon/Epogin
  • Interferon beta products
  • Neupogen/Neutrogin
  • Approval process
• 4. Expiries in 2005
  • Overview
  • Major Patent Expiries In Europe
  • Major patent expiries in the United States
  • Potential revenue loss
  • Advair/Seretide
  • glimepiride (Amaryl)
  • clarithromycin (Biaxin/Klacid)
  • cefprozil (Cefzil/Procef)
  • fentanyl (Duragesic)
  • enoxaparin (Lovenox)
  • clopidogrel (Plavix)
  • pravastatin (Pravachol/ Mevalotin)
  • ceftriaxone (Rocephin)
  • azithromycin (Zithromax)
• 5. Expiries in 2006
  • Overview
  • Major Patent Expiries In Europe
  • Major patent expiries in the United States
  • Potential revenue loss
  • zolpidem tartrate (Ambien/Stilnox/Myslee)
  • carvedilol (Coreg/Dilatrend)
  • tersbinafine (Lamisil)
  • finasteride (Proscar)
  • simvastatin (Zocor)
  • ondansetron (Zofran)
  • sertraline (Zoloft)
• 6. Expiries in 2007
  • Overview
  • Major Patent Expiries In Europe
  • Major patent expiries in the United States
  • Potential revenue loss
  • irinotecan (Camptosar, Campto, Topotecin)
  • sumatriptan (Imigran/Imitrex)
  • granisetron hydrochloride (Kytril)
  • esomeprazole (Nexium)
  • amlodipine besylate (Norvasc)
  • paroxetine hydrochloride (Paxil/Seroxat)
  • budesonide (Pulmicort)*
  • risperidone (Risperdal)
  • cetirizine (Zyrtec)
• 7. Expiries in 2008
  • Overview
  • Major Patent Expiries In Europe
  • Major patent expiries in the United States
  • Potential revenue loss
  • bicalutamide (Casodex)
  • ramipril (Delix/Tritace)
  • divalproex sodium (Depakote/Valcote)
  • venlafaxine (Effexor)
  • alendronate (Fosamax/Bonalon)
  • lamotrigine (Lamictal)
  • meloxicam (Mobic)
  • tacrolimus (Prograf and Protopic)
  • salmeterol (Serevent)
• 8. Expiries in 2009
  • Introduction
  • Major Patent Expiries In Europe
  • Major patent expiries in the United States
  • Potential revenue loss
  • adenosine injection (Adenoscan/Adenocard)
  • mycophenolate mofetil (Cellcept)
  • tamsulosin (Flomax, Omnic, Harnal)
  • levetiracetam (Keppra)
  • escitalopram (Lexapro/Cipralex)
  • pantoprazole (Protonix)
  • micronized fenofibrate (TriCor/Lipanthyl)
  • orlistat (Xenical)
• List of Figures
  • Figure 2.1 2004 revenues in the United States for drugs going off patent in the year indicated.
  • Figure 2.2 Number of potential generic market entries in the United States 2005 to 2009
  • Figure 2.3 Number of potential generic market entries in the France, Germany and the United Kingdom 2005 to 2009
  • Figure 2.4 Number of chemical entities likely to be exposed to generic competition between 2005 and 2009.
  • Figure 2.5 Potential revenue loss (of 2004 U.S. sales) to generic competition for the top 20 pharmaceutical companies plus Forest and King.
  • Figure 3.1 US sales of Prozac and generic fluoxetine 2000-2004.
  • Table 3.1 Leading Biotechnology therapeutics showing global reported sales for 2003 and 2004.
  • Table 8.1 Major drugs whose patents expire in France, Gemany and/or the United Kingdom in 2009.
• List of Tables
  • Table 4.1 Major drugs whose patents expire in France, Germany and/or the United Kingdom in 2005.
  • Table 4.2 Major Drugs whose patent protection and marketing exclusivity expires in the United States in 2005.
  • Table 5.1 Major drugs whose patents expire in France, Gemany and/or the United Kingdom in 2006.
  • Table 5.2 Major Drugs whose patent protection and marketing exclusivity expires in the United States in 2006
  • Table 6.1 Major drugs whose patents expire in France, Gemany and/or the United Kingdom in 2007.
  • Table 6.2 Major Drugs whose patent protection and marketing exclusivity expires in the United States in 2007.
  • Table 7.1 Major drugs whose patents expire in France, Gemany and/or the United Kingdom in 2008.
  • Table 7.2 Major Drugs whose patent protection and marketing exclusivity expires in the United States in 2008.
  • Table 8.2 Major Drugs whose patent protection and marketing exclusivity expires in the United States in 2009.