Generic competition and market exclusivity periods in pharmaceuticals

Henry G. Grabowski · Margaret Kyle

169 citations0/0 files storedManagerial and Decision Economics

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Pharmaceutical Economics and Policy Healthcare Policy and Management Intellectual Property and Patents

Abstract

Abstract In this paper we examine generic competition and market exclusivity periods for pharmaceuticals experiencing their initial generic entry between 1995 and 2005. We find that generic competition has increased over several dimensions. First, an increasing number of drugs are subject to generic entry, including drugs with relatively modest annual average sales. Second, drugs with larger sales attract more generic entrants and have shorter market exclusivity periods than smaller selling drugs. Third, blockbuster drugs with annual sales in excess of $1 billion have experienced significant decreases in their market exclusivity periods in recent years. We also find that Hatch‐Waxman Act patent challenges have negatively affected market exclusivity periods over the 1995 to 2005 period. Copyright © 2007 John Wiley & Sons, Ltd.

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References

2003The price of innovation: new estimates of drug development costs 1992Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act 2005Generic Drug Industry Dynamics 2002Returns on Research and Development for 1990s New Drug Introductions 1999Entry Decisions in the Generic Pharmaceutical Industry 1994Returns to R&D on new drug introductions in the 1980s 1997Entry Decisions in the Generic Pharmaceutical Industry

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