Watson files Para IV for Loestrin 24 FE

Watson has recently filed a Para IV certification for oral contraceptive Loestrin 24 FE marketed by Warner Chilcott. Watson moved ANDA with US FDA seeking marketing approval for generic Loestrin 24 FE prior to expiration of orange book listed U.S. Patent No. 5,552,394 which run through Jul 2014 contending that the ‘394 is invalid and unenforceable or its generic product do not infringe the ‘394 patent. Subsequently, Watson notified Warner of Para IV certification on June 23, 2006 triggering Warner’s 45 days time limit to launch patent litigation against Watson. As of date, Warner has not commenced patent litigation against Watson. Loestrin 24 FE (a combination of ethinyl estradiol and norethindrone acetate tablets, and ferrous fumarate tablets), is an oral contraceptive drug which is recently approved by US FDA for the prevention of pregnancy.