Abstract
"The period 2005 to 2009 will see the expiration of patent protection for 39 major drugs in
the United States, an average of 8 a year. With 2004 seeing a decline in the number of NCEs approved
down to 23 from 27 in 2003, 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."
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
has 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.
With this background, Urch Publishing has commissioned a study into the effect of patent expiries
on some of the major branded pharmaceutical products.
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 holders competitors
- See whether there are any outstanding litigation issues
- Learn which generic companies are active in filing
Remember!
The increasing use of generic therapeutics, which combine high volumes with low prices, has led
generics to capture 14% of the global healthcare market in 2004, with overall revenues of $58
billion. The imminent patent expirations of many major drugs, 42 in the period 2005 to 2009 in major
markets, will provide a major growth stimulus for the generics companies as they compete to capture
market share from multi-billion dollar drugs whose patents expire in this period.
You have been warned!
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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