A New History and Discussion of 180-Day Exclusivity
Food and Drug Law Journal, Vol. 64, No. 2, 2009
57 Pages Posted: 18 Feb 2013
Date Written: February 17, 2013
This is the third in a series of articles on 180-day exclusivity. The first article traced the history of 180-day exclusivity from 1984 through its amendment in 2003 and court cases in 2004. A second article, published by two of the authors in 2007, updated the earlier piece through the end of 2006 but was arranged by issue rather than in a chronology. This article, which includes a third author, provides a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) and focuses more discussion on the new provisions as well as some policy and legal issues related to 180-day exclusivity.
Keywords: Hatch-Waxman, 180-day exclusivity, generic drugs, ANDAs
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