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PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. has begun shipping pioglitazone hydrochloride tablets (15mg, 30mg and 45mg), a diabetes medication.
Watson said it released the product, a generic version of Mylan’s Actos, after receiving final approval Friday from the Food and Drug Administration.
The product launch came following a legal dispute. Watson said that on Aug. 15, 2012, it announced that it had filed suit against the FDA challenging the agency’s decision regarding the company’s entitlement to shared exclusivity for its generic Actos and that Mylan Pharmaceuticals Inc. subsequently intervened as a defendant in the action. On Oct. 22, the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve Watson’s ANDA.
Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit, but the appeals court has denied Mylan’s motion for a stay of the judgment pending the appeal, according to Watson.
An oral diabetes medicine that helps regulate blood sugar levels, pioglitazone is indicated for people with type 2 diabetes.
For the 12 months ended Aug. 31, Actos and its generic equivalents had total U.S. sales of about $2.7 billion, according to IMS Health data reported by Watson.
