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Watson Pharma Sues FDA On Delay Of Generic Version Of Actos - Quick Facts

Watson Pharmaceuticals Inc. (WPI) has filed suit against the U.S. Food and Drug Administration or FDA challenging the Agency's decision relating to Watson's entitlement to shared exclusivity for its generic version of Actos. Because of FDA's decision, Watson's abbreviated new drug application or ANDA could be delayed for up to six months. Watson said 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 would 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.

Watson planned to introduce its generic version of Actos on August 17, 2012, as per a settlement deal on March 10, 2010 with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America. According to pre-Medicare Modernization Act Hatch Waxman rules, Watson believes it is entitled to share in the 180 day period of generic marketing exclusivity.

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