FDA Extends Lilly's Prozac Patent
Nov. 16, 2000
INDIANAPOLIS (AP) _ The U.S. Food and Drug Administration has extended Eli Lilly & Co.'s patent on the antidepressant Prozac for an additional six months.
The extension, announced Wednesday, comes because the company agreed to test the antidepressant on children. Under the FDA Modernization Act of 1997, pharmaceutical companies that comply with FDA requests for pediatric studies on selected medications can receive an extra six months of market exclusivity for those products.
Unless Lilly prevails with its pending appeal concerning the 2003 Prozac patent, the extension will begin February 2, 2001, upon the expiration of the 2001 Lilly Prozac patent, and will end August 2, 2001.
During this time, no generic forms of the antidepressant will be allowed in the United States market.
Shares of Eli Lilly closed at $87.69, down 19 cents a share.