Mylan settles with Shionogi and Andrx over Fortamet; Merck & Co diagnostics deal with Luminex

14 March 2013

US generic drugmaker Mylan (Nasdaq: MYL) has entered into a settlement agreement with Japan’s Shionogi (TYO: 4507) and privately-held Andrx that will resolve patent litigation related to metformin hydrochloride extended-release tablets USP, 500mg and 1,000mg, a 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 accord, 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 US Department of Justice and the Federal Trade Commission.

Metformin in the specified dosage forms generated US sales of around $125 million for the 12 months ending September 30, 2012, according to IMS Health data quoted by Mylan.

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