Warner Chilcott Plc, the maker of dermatology and women’s health drugs, sued Watson Pharmaceuticals Inc. to prevent it from selling a generic version of its oral contraceptive Lo Loestrin Fe.
Watson is seeking U.S. Food and Drug Administration approval to sell a copy of the low-dose contraceptive, according to a complaint filed yesterday in federal court in Trenton, New Jersey. Dublin-based Warner Chilcott said the Watson version would infringe two patents and seeks a court order to prevent sales until patents expire in July 2014 and February 2029.
The lawsuit follows Warner Chilcott’s announcement on April 30 that it is exploring options and holding preliminary talks with buyers. Warner Chilcott had $2.7 billion in revenue last year, with sales led by osteoporosis treatment Actonel, Asacol for ulcerative colitis and Loestrin 24 FE, a low-dose birth-control pill.
Under federal drug law, the filing of the lawsuit prevents the FDA from granting Watson final approval for 30 months unless a court rules in the generic-drug maker’s favor before then.
Charlie Mayr, a spokesman for Parsippany, New Jersey-based Watson, didn’t immediately return a call seeking comment.
Lo Loestrin Fe contains the active ingredients norethindrone acetate and ethinyl estradiol.
The case is Warner Chilcott v. Watson Laboratories, 12-cv-2928, U.S. District Court, District of New Jersey (Trenton).