Watson sues FDA over generic Actos

Drug maker alleges FDA decision would improperly delay generic launch by six months

PARSIPPANY, N.J. — Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

Watson said it was entitled to share market exclusivity for a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone). Under the Hatch-Waxman Act of 1984, the first company to file a complete regulatory approval application with the FDA for a generic version of a drug is entitled to 180 days in which to compete exclusively with the branded version upon approval. In some cases, multiple companies share exclusivity, and a 2010 settlement with Takeda would allow Watson, Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs to launch generic versions of Actos this Friday.

Watson said the FDA denied its claim of shared exclusivity based on the timing of its reinstatement of several of its original Paragraph IV certifications, a type of challenge to a branded drug maker's patent commonly issued by generic drug companies. Watson said it had converted its Paragraph IV certification to a different type of challenge at the FDA's direction, later reinstating the Paragraph IV certification after it settled a patent-infringement suit with Takeda. The FDA's denial of Watson's claim would delay its launch of the drug by six months, the company said.

"When we learned of [the] FDA's position regarding our application, we made efforts to work cooperatively with [the] FDA to resolve the situation," Watson president and CEO Paul Bisaro said. "[The] FDA has refused to grant shared exclusivity and seeks to unnecessarily delay the launch of Watson's generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action."

Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.


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