Law Commons^™

A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott

Faculty Publications

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 …