Evolution of Market Exclusivity, Paragraph IV Challenges and Generic Penetration

Henry.G Grabowski (), Margaret Kyle, Richard Mortimer, Genia Long and Noam Kirson
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Margaret Kyle: stratégie - TSE-R - Toulouse School of Economics - UT Capitole - Université Toulouse Capitole - UT - Université de Toulouse - INRA - Institut National de la Recherche Agronomique - EHESS - École des hautes études en sciences sociales - CNRS - Centre National de la Recherche Scientifique - CRM - Centre de Recherche en Management - UT Capitole - Université Toulouse Capitole - UT - Université de Toulouse - IAE - Institut d'Administration des Entreprises - Toulouse - CNRS - Centre National de la Recherche Scientifique

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Abstract: The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs

Keywords: "Drug Policy"; Drug Policy (search for similar items in EconPapers)
Date: 2012
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Published in Health Affairs, 2012, 30 (11), pp.2157-2166. ⟨10.1377/hlthaff.2010.0270⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:halshs-00738629

DOI: 10.1377/hlthaff.2010.0270

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