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

See all articles by David Korn

David Korn

Pharmaceutical Research and Manufacturers of America (PhRMA)

Erika Lietzan

University of Missouri School of Law

Shaw Scott

Covington & Burling

Date Written: February 17, 2013

Abstract

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

Suggested Citation

Korn, David and Lietzan, Erika and Scott, Shaw, A New History and Discussion of 180-Day Exclusivity (February 17, 2013). Food and Drug Law Journal, Vol. 64, No. 2, 2009. Available at SSRN: https://ssrn.com/abstract=2219949

David Korn

Pharmaceutical Research and Manufacturers of America (PhRMA)

1100 Fifteenth Street, NW
Washington, DC 20005
United States

Erika Lietzan (Contact Author)

University of Missouri School of Law ( email )

Missouri Avenue & Conley Avenue
Columbia, MO MO 65211
United States

Shaw Scott

Covington & Burling

1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States

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