Watson sues FDA over generic versions of diabetes drug, Actos

Hannah Blake

pharmaphorum

Watson Pharmaceuticals has filed a law suit against the US FDA, challenging the Agency’s decision regarding Watson’s entitlement to shared exclusivity for its generic version of Takeda Pharmaceutical’s diabetes drug, Actos.

Actos (pioglitazone hydrochloride) is a prescription medication to improve glucose control in adults with type 2 diabetes. Due to the FDA’s decision, Watson’s abbreviated new drug application (ANDA) could now be delayed for up to six months. The company had planned to launch the generic version of Actos on August 17th, after a 2010 settlement with the Japanese drugmaker, Takeda Pharmaceuticals.

Watson believes that the FDA improperly denied the company’s shared exclusivity, despite the company following directions received from the FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing. Typically, the first company that files for approval of a generic version of an off-patent drug gets marketing exclusivity for 180 days.

"When we learned of FDA's position regarding our application, we made efforts to work cooperatively with FDA to resolve the situation. 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. We believe that we have sound arguments that refute FDA's position and will seek the court's intervention to enable approval."

Paul Bisaro, Watson's President and CEO.

Watson has noted that in the event the FDA fails to timely approve its ANDA for generic Actos, it remains confident it can achieve its most recently disclosed forecast for full year 2012.