Purepac Pharmaceutical Company v. FDA, U.S District Court 1998

Case Description

In this case, a United States district court ruled that successfully defending a patent infringement dispute is not a necessary requirement for a generic manufacturer to benefit from a 180-day exclusivity period. US law provides, under certain circumstances, a 180-day period of exclusivity to reward the first launch of a generic copy of an originator drug.

Decision Year
1998
Case Summary