Watson Pharmaceuticals has filed suit against the FDA challenging the agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of type 2 diabetes drug 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, according to Watson, which noted that it filed suit after communications with FDA about its ANDA failed to resolve the dispute and permit a timely launch.
Parsippany, N.J.-based Watson said that the "FDA improperly denied its 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 it filed paragraph IV (PIV) 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. The company previously converted its certifications 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 Aug. 17, based on a settlement agreement on March 10, 2010 with Takeda Pharmaceutical and Takeda Pharmaceuticals North America.
Under pre-Medicare Modernization Act Hatch Waxman rules, Watson claimed it is entitled to share in the 180-day period of generic marketing exclusivity. For the 12 months ending May 31, Actos had total U.S. sales of approximately $2.7 billion, according to IMS Health data, reported by the company.
Watson noted that if FDA fails to provide timely approval of 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 U.S. generics business."