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Mylan, Takeda reach agreement on Actos, Actoplus Met patents

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PITTSBURGH Mylan has settled patent litigation cases with Takeda concerning two diabetes drugs, the generic drug maker said Tuesday.

Takeda had sued Mylan for patent infringement when it filed regulatory approval applications with the Food and Drug Administration for Actos (pioglitazone hydrochloride) and Actoplus Met (pioglitazone hydrochloride and metformin).

Under the agreements, Mylan will have the right to begin marketing its version of Actos in the 15-mg, 30-mg and 45-mg strengths in August 2012 and its version of Actoplus Met in the 15-mg/500-mg and 15-mg/850-mg strengths four months later. Patents covering both drugs expire in 2016.

Actos had sales of $3.4 billion in 2009, while Actoplus Met had sales of $459 million, according to IMS Health.

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