The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.

J Health Econ

Department of Economics, Owen G Glenn Building, The University of Auckland, Auckland, New Zealand.

Published: January 2011

This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences.

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http://dx.doi.org/10.1016/j.jhealeco.2010.09.004DOI Listing

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