Generic drug antitrust settlement with US FTC

The US Federal Trade Commission has accepted the settlement of a long-standing law suit against Bermuda-headquartered drugmaker Warner Chilcott for its chewable oral combined hormonal contraceptive Ovcon 35 (norethindrone and ethinyl estradiol). The deal means that US drugmaker Barr Pharmaceuticals can now launch a generic form of Ovcon, using the trade name Balziva. The settlement requires approval by the US District Court for the District of Columbia.

The law suit questions the legality of authorized generics and arrangements between patent holders and potential generic drugmakers when patent expiry is nearing.

By agreeing to settle, Warner Chilcott has lifted its exclusivity provision for Barr's license to bring a generic version of Ovcon35 to market. Bruce Downey, Barr's chief executive, said: "following the launch of our Balziva product in October, we will manufacture and market a generic oral contraceptive portfolio that is the largest in the industry, totaling 24 products." The firm added that it does not anticipate receiving any further orders for the drug from Warner Chilcott, which was manufactured by Barr on behalf of the patent holder.