Wyeth files suit to block Sandoz’s generic Lybrel

NEW YORK Wyeth alleges that Sandoz’s generic version of the oral contraceptive Lybrel violates Wyeth’s patent.

Wyeth has filed a lawsuit in the U.S. District Court for the District of Delaware against Sandoz over its version of Lybrel (90 microgram levonorgestrel/20 microgram ethinyl estradiol tablets), alleging that Sandoz’s application to the Food and Drug Administration for a generic version of the drug infringed on the ‘814 patent.

Watson Pharmaceuticals notified Wyeth in a letter on Jan. 28 that it had filed an application for FDA approval of a generic version of Lybrel, prompting Wyeth to respond with a lawsuit. Wyeth received FDA approval for Lybrel in May 2007, and the patent for the drug expires in September 2018.

Wyeth reported first-quarter 2008 contraceptive sales of $104.35 million. Based in Holzkirchen, Germany, Sandoz is a subsidiary of Novartis.