Table of Contents
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. 92
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