Food and Drug Administration
gave the company an additional six months of marketing exclusivity for Prozac.
The company said it received the extension on the Prozac patent after it submitted data to the FDA earlier this year regarding the effects of the drug for the treatment of child and adolescent depression. The FDA didn't make any determinations about the safety or effectiveness of Prozac in pediatric patients.
Unless Lilly prevails with its pending appeal concerning the 2003 Prozac patent, the extension will begin Feb. 2, 2001 and will end Aug. 2, 2001. During this time, no generic forms of the antidepressant will be allowed in the U.S. market.
Shares of Eli Lilly were recently unchanged at $87.88 on the
New York Stock Exchange