The US Court of Appeals for the First Circuit ruled this week that agreements to keep generic versions of drugs off the market for considerations other than cash payments deserve antitrust scrutiny. The case involved Warner Chilcott's deals with Watson Pharmaceuticals and Lupin Pharmaceuticals over the oral contraceptive Loestrin.
Lupin and Warner Chilcott have agreed to resolve patent-infringement lawsuits regarding the latter's oral contraceptives Loestrin 24 Fe and Femcon Fe. The settlement gives Lupin a nonexclusive right to market a generic of Femcon Fe in 2013 but does not allow the generic-drug maker to launch a copy of Loestrin 24 Fe before patent expiration. In addition, Warner granted Lupin rights to buy and sell an authorized copy of a 400-milligram dose of Asacol, a treatment for ulcerative colitis.
Salix Pharmaceuticals Ltd. on Monday announced it submitted a new drug application for once-a-day dosing of granulated mesalamine to prevent the recurrence of ulcerative colitis. On the same day, Mylan announced that the FDA has approved its generic version of Colazal, Salix's key product for ulcerative colitis.