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"In the US these expiries will happen at a steadily increasing rate,peaking at 20 in 2012. However, the revenue loss will be morecatastrophic, with the peak exposure of high-earning products occurring in 2011, when both Lipitor and Plavix are now expected toface generic competition."

The period 2009–13 will see major companies facing very different degrees of exposure to the potential loss of revenue to generics.

Eli Lilly, Pfizer, Bristol-Myers Squibb, Merck and Takeda all face the potential loss of over 40% of their revenues, while companies such as Roche, Abbott and Astellas face minimal exposure.

Others face varying degrees of exposure – often around 20% – and for many companies the most critical years will be 2011 and/or 2012. Potentially the most seriously impacted, because of their over-reliance on a single product are Pfizer, for which Lipitor accounted for 25% of its 2007 revenues, and Bristol-Myers Squibb, for which Plavix accounted for 30% of its 2007 revenues.

2009 loss of patent protection for 10 products in Europe and potentially 7 in the US. In Europe the most significant development will be the loss of market exclusivity for two of the leading anti-ulcer drugs, namely Nexium and Pantozol. In the US the most significant patent expirations will be for the anti-ulcer drug Prevacid and for the anticonvulsant Topamax.

2010 loss of patent protection for 6 products in Europe and 10 in the US. In Europe the most significant loss of exclusivity will be for the anticonvulsant Keppra, while in the US Advair will potentially lose exclusivity, although generics will be less readily introduced. Also losing exclusivity will be the blockbusters Cozaar, Protonix and Aricept.

2011 will be potentially a nadir for the innovative pharmaceutical industry, with four products with combined US sales of $16bn (in 2007) amongst those losing market exclusivity. In Europe 11 products, most notably Lipitor but also Actos and Zyprexa, will lose market exclusivity. In the US a total of 13 products will lose exclusivity. While Lipitor with 2007 sales of $7.2bn will be the most significant, several other blockbuster agents will also lose exclusivity: Plavix $4.1bn, Seroquel $2.9bn, Actos $2.3bn, Zyprexa $2.2bn and Levaquin $1.6bn.

2012 will see a large number of drugs lose patent protection – a total of 20 significant products in the US and 14 in Europe. The most significant developments in Europe will be the loss of exclusivity for the antihypertensives Atacand and Aprovel. In the US the 20 drugs losing exclusivity will include three with 2007 US sales in excess of $2bn: the antidepressant Lexapro, the anti-asthmatic agent Singulair and the antihypertensive Diovan.

2013 will see the loss of patent protection for 10 products in Europe and 9 in the US. In Europe the key developments will be the loss of exclusivity for Plavix and Seretide plus a number of antiviral agents. In the US the key developments will be the loss of exclusivity for Aciphex and for Cymbalta.

Generic Competition 2009 to 2013: The impact of patent expiries on sales of major drugs is a 53,000 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 2003-98 (total and US)
% of company’s 2007 revenues
Share of market segment
Key competitors
Patent Status in US, Japan, France, Germany, Italy, Spain 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 40 major drugs that will come off patent between 2009 and 2013
• Listing of generic regulatory filing activity
• Solid overview of market for generic drugs over the next four years
• Global product sales figures for years 2005-2008 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

Chapter 1: The Impact of Patent Expiries, 2009-13
Introduction
Patent expiry by date
Major generics companies

Chapter 2: Historical and Legal Context
Impact of generics on revenue
Patent regulations
Europe
US

Chapter 3: Generic Biotechnology Products (Biosimilars)
Introduction
Biosimilars
Entry barriers

Potential biogenerics by 2013
Legal status
Patent expiries for leading biologicals
Chapter 4: Major Generic Opportunities
Overview
Plavix
Advair
Lipitor
US generic potential

 

Chapter 5: Impact on Major Companies
Introduction

Chapter 6: 2009
Overview
Major patent expiries in Europe
Major patent expiries in the US
Potential revenue loss
Key European patent expiry

Review of drugs with 2009 US patent expiries

Chapter 7: 2010
Overview
Major patent expiries in Europe
Major patent expiries in the US
Potential revenue loss
Review of drugs with 2010 US patent expiries

Chapter 8: 2011
Overview
Major patent expiries in Europe
Major patent expiries in the US
Potential revenue loss
Review of drugs with 2011 US patent expiries
Capecitabine (Xeloda)
Pioglitazone (Actos)
Latanoprost (Xalatan/Xalcom)
Pemetrexed disodium (Alimta)
Exemestane (Aromasin)
Olanzapine (Zyprexa)
Letrozole (Femara)
Levofloxacin hydrochloride (Levaquin/Cravit/Tavanic)
Clopidogrel bisulfate (Plavix/Iscover)
Goserelin acetate implant (Zoladex)
Risedronate sodium (Actonel/Benet)
Atorvastatin calcium (Lipitor)

Chapter 9: 2012
Overview
Major patent expiries in Europe
Major patent expiries in the US
Potential revenue loss
Review of drugs with 2012 US patent expiries

Chapter 10: 2013
Overview
Major patent expiries in Europe
Major patent expiries in the US
Potential revenue loss
Review of drugs with 2013 US patent expiries

List of Figures
Figure 1.1 2007 revenues in the US for drugs going off patent in the year indicated
Figure 1.2 Number of potential commercially significant US generics market entries, 2009-13
Figure 1.3 Number of potential French, German and UK generics market entries, 2009-13
Figure 2.1 European generics industry showing respective market shares by value and volume in each of the five major European markets in 2006
Figure 2.2 US sales of Prozac and generic fluoxetine, 2000-05
Figure 2.3 Quarterly US sales of Plavix, 2004-08
Figure 5.1 Potential exposures of the 20 leading pharmaceutical companies' revenues to generic competition, 2009-13
Figure 5.2 Potential exposure of the US revenues of the 20 leading pharmaceutical companies to generic competition by year in the period 2009-13
Figure 5.3 Expiry dates of key US drug patents by year in the period 2009-13 for the 20 leading pharmaceutical companies
Figure 6.1 US revenues at risk from patent expirations during 2009
Figure 7.1 US revenues at risk from patent expirations during 2010
Figure 8.1 US revenues at risk from patent expirations during 2011
Figure 9.1 US revenues at risk from patent expirations during 2012
Figure 10.1 US revenues at risk from patent expirations during 2013

 

List of Tables
Table 1.1 Leading generics companies' revenues, 2007
Table 3.1 Leading biotechnology therapeutics (excluding insulin derivatives and vaccines) showing reported global sales for 2006 and 2007
Table 3.2 Patent expiration dates of key patents on leading classes of biological agents in the US and Europe
Table 4.1 The world's best-selling drugs in 2007
Table 4.2 Top-selling generic drugs in the US market in 2007
Table 5.1 AstraZeneca products facing generic threats, 2009-13
Table 5.2 Boehringer Ingelheim products facing generic threats, 2009-13
Table 5.3 Eli Lilly products facing generic threats, 2009-13
Table 5.4 GlaxoSmithKline products facing generic threats, 2009-13
Table 5.5 Johnson & Johnson products facing generic threats, 2009-13
Table 5.6 Merck products facing generic threats, 2009-13
Table 5.7 Novartis products facing generic threats, 2009-13
Table 5.8 Pfizer products facing generic threats, 2009-13
Table 5.9 Roche products facing generic threats, 2009-13
Table 5.10 Sanofi-Aventis products facing generic threats, 2009-13
Table 5.11 Takeda products facing generic threats, 2009-13
Table 6.1 Significant drugs whose patents expire in France, Germany and/or the UK in 2009
Table 6.2 Significant drugs whose patent protection and/or marketing exclusivity expires in the US in 2009
Table 7.1 Significant drugs whose patents expire in France, Germany and/or the UK in 2010
Table 7.2 Significant drugs whose patent protection and/or marketing exclusivity expires in the US in 2010
Table 8.1 Significant drugs whose patents expire in France, Germany and/or the UK in 2011
Table 8.2 Significant drugs whose patent protection and/or marketing exclusivity expires in the US in 2011
Table 9.1 Significant drugs whose patents expire in France, Germany and/or the UK in 2012
Table 9.2 Significant drugs whose patent protection and/or marketing exclusivity expires in the US in 2012
Table 10.1 Significant drugs whose patents expire in France, Germany and/or the UK in 2013
Table 10.2 Significant drugs whose patent protection and/or marketing exclusivity expires in the US in 2013

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.