US based Watson Pharmaceuticals has filed a legal case against US Food and Drug Administration's (FDA) decision regarding the company's exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets).
The company's abbreviated new drug application (ANDA) may be delayed for up to six months following the agency's decision.
Watson has filed a suit after communicating with FDA regarding its ANDA.
FDA has improperly denied its shared exclusivity despite following directions received from FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing, according to Watson.
The FDA denied Watson's claim of shared exclusivity basing on the timing of Watson's reinstatement of several of its original PIV patent certifications.
The law 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.
Watson president and CEO Paul Bisaro said when the company learned of FDA position regarding ANDA, Watson 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,'' Bisaro added.
''We believe that we have sound arguments that refute FDA's position and will seek the court's intervention to enable approval."
Watson has planned to launch Actos on 17 August 2012 in pursuance to a settlement agreement on 10 March 2010 with Takeda Pharmaceutical and Takeda Pharmaceuticals North America.
