PITTSBURGH, March 13, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) 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.(1)
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.
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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