Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with Shionogi Inc. and Andrx that will resolve patent litigation related to Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg. This product is the generic version of Shionogi's Fortamet, and is indicated as an adjunct to diet and exercise to lower blood glucose.
Under the terms of the settlement agreement, Mylan may launch a generic version of Fortamet@ on August 1, 2013, or earlier under certain conditions. Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, had U.S. sales of approximately $125 million for the 12 months ending Sept. 30, 2012, according to IMS Health.