Watson Pharmaceuticals, Inc., an integrated global specialty pharmaceutical company, has filed suit against the US Food and Drug Administration (FDA) challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets).
As a result of FDA's decision, Watson's abbreviated new drug application (ANDA) could be delayed for up to six months. Watson noted that it filed suit after communications with FDA regarding its ANDA failed to resolve the dispute and permit a timely launch. Watson maintains that FDA improperly denied the company's shared exclusivity despite the company directly following directions received from FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing.
Watson's suit will argue that the company properly filed paragraph IV certifications to certain patents for Actos listed in the FDA Orange Book in its original 2003 ANDA filing. The FDA denied Watson's claim of shared exclusivity based on the timing of Watson's reinstatement of several of its original PIV patent certifications, which the company previously converted from a PIV to a section VIII at FDA's direction, and then reinstated back to a PIV patent certification following the settlement of patent litigation.
"When we learned of FDA's position regarding our application, we made efforts to work cooperatively with FDA to resolve the situation," said Paul Bisaro, Watson's president and CEO. "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."
Watson planned to launch its generic version of Actos on August 17, 2012, pursuant to a settlement agreement on March 10, 2010 with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America. Under pre-Medicare Modernization Act Hatch Waxman rules, Watson believes it is entitled to share in the 180 day period of generic marketing exclusivity. For the twelve months ending May 31, 2012, Actos had total U.S. sales of approximately $2.7 billion according to IMS Health data.
Watson noted that in the event FDA fails to timely approve its ANDA for generic Actos, it remains confident that it can achieve its most recently disclosed forecast for full year 2012 due to a recent favorable update from the FDA related to another product and improved market conditions for certain products within the US generics business.