Barr challenges Lilly Prozac patents; fluoxetine ANDA accepted for filing in February.
Executive Summary
BARR CHALLENGES LILLY PROZAC COMPOSITION AND USE PATENTS in an effort to market generic fluoxetine before expiration of two Lilly patents. Lilly filed suit April 10 in Indianapolis federal court in response to Barr's paragraph 4 certification in its fluoxetine ANDA. Barr submitted the ANDA in December, and FDA accepted it for filing in February, triggering Waxman/Hatch notification to Lilly Feb. 28. Barr must respond to the suit by May 3.