Diflucan generics approved

Executive Summary

Diflucan generics enter market July 29 following expiration of Pfizer's pediatric exclusivity. FDA approved 22 ANDAs for tablet, oral suspension and injection forms of fluconazole. Pfizer is marketing its own generic tablet and oral suspension through its Greenstone subsidiary. Because Pfizer's only "Orange Book" listed patent has expired, none of the ANDA filers will enjoy 180 days of marketing exclusivity. Ranbaxy's attempt to enter the market earlier was rebuffed by FDA and the courts (1"The Pink Sheet" May 10, 2004, In Brief)...