Lilly Prozac

Fluoxetine will have six months of pediatric exclusivity beginning Feb. 2 when Lilly's patent no. 4,314,081 expires. The additional exclusivity is based on clinical data in adolescents aged seven to 17 from two pediatric depression studies, an obsessive compulsive disorder study and a pharmacokinetic study submitted to FDA. If Lilly is granted a rehearing in appeals court or a review in the Supreme Court for its invalidated Prozac patent (No. 4,626,549), which would have expired in 2004, it could delay Barr's 180 days of Waxman/Hatch exclusivity for generic fluoxetine (1"The Pink Sheet" Oct. 30, p. 14)