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Watson introduces generic version of Actos

Watson Pharmaceuticals has introduced Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets, a generic equivalent to Actos.

The company began the shipment of the product after winning the final FDA approval.

Actos is a prescription medication indicated for type 2 diabetes used along with diet and exercise to improve blood sugar (glucose) control in adult patients.

Based on IMS Health data, Actos and its generic equivalents had total US sales of approximately $2.7bn for 12 months ending 31 August 2012.

Watson had previously filed a suit challenging the FDA’s decision regarding the company’s right to shared exclusivity for its generic Actos while Mylan Pharmaceuticals consequently intervened as a defendant in the action.

Later, the US District Court for the District of Columbia ruled in favor of Watson by ordering FDA to approve Watson’s ANDA.

Mylan appealed the judgment in the Appeals court, which as a response denied Mylan’s motion for a stay of the judgment awaiting the appeal.