Generic Competition to 2009: The impact of patent expiries on sales of major drugs
An Urch Pharmaceutical Industry Report, written by Dr Peter Norman, explains the effect of patent expiries on some of the major branded pharmaceutical products.
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ABOUT THE AUTHOR Peter Norman is a pharmaceutical consultant and analyst with specialist knowledge of the respiratory disease and inflammation markets. He has written and presented widely on various aspects of respiratory disease and on the analysis of therapeutic markets. Dr. Norman has over 20 years experience of the pharmaceutical industry in both R&D and competitive intelligence. His publications include many reviews and management reports, sixteen original scientific papers and eleven patents. Dr. Norman holds science degrees from Cambridge University and Brunel University plus a M.B.A. degree from the Open University.SUMMARY "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 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 holder’s 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! 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 process4. 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