Watson sues US FDA regarding generic Actos approval delay

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) says it has filed suit against the US Food and Drug Administration challenging the agency's decision regarding Watson's entitlement to shared exclusivity for its copy version of Japanese drug major Takeda Pharmaceutical’s (TYO: 4502) blockbuster 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 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.