Barr Pharmaceuticals's subsidiary, Barr Laboratories Inc, has received approval from the US FDA for its application to manufacture and market a generic version of Bristol Myers Squibb's Glucophage XR (metformin hydrochloride extended-release tablets) 750 mg. The FDA's approval letter awarded Barr 180 days of generic exclusivity under the provisions of Hatch-Waxman.

Barr filed an Abbreviated New Drug Application (ANDA) for metformin hydrochloride extended-release tablets, 750 mg that contained a challenge to the patent listed in the Orange Book for Glucophage XR. Bristol Myers Squibb subsequently listed an additional patent in the Orange Book. Barr amended its ANDA to contain a challenge to that additional patent. Bristol Myers Squibb did not bring suit against Barr within the 45-day period provided for by the Hatch-Waxman Act on either of the listed patents, the company said here.

Glucophage XR (metformin hydrochloride extended-release tablets), as a monotherapy, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes in patients 17 years of age and older. Glucophage XR, 750 mg had annual sales of approximately $25 million for the twelve months ended July 2004, based on IMS data.

Barr Pharmaceuticals Inc, a holding company that operates through its principal subsidiaries, Barr Laboratories Inc and Duramed Pharmaceuticals, Inc, is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.