Regulatory Focus™ > News Articles > Watson Files Suit Against FDA over 180-Day Exclusivity

Watson Files Suit Against FDA over 180-Day Exclusivity

Posted 16 August 2012 | By Alexander Gaffney, RAC 

Generics manufacturer Watson Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) in an attempt to compel the agency to grant it 180-day generic marketing exclusivity for its generic version of anti-diabetes drug Actos (pioglitazone).

Under a 2010 settlement between Actos' manufacturer, Takeda Pharmaceuticals of Japan, Watson, Mylan Inc and Ranbaxy Laboratories all received what Watson referred to as "shared exclusivity." Under normal circumstances, the first company to file an Abbreviated New Drug Application (ANDA) with FDA after the patent for a drug expires receives 180 days of marketing exclusivity under a federal law meant to spur the development of generic drugs.

FDA, however, refused to grant Watson a license for shared exclusivity, prompting the lawsuit, Watson explained in a statement.

"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," said Paul Bisaro, president and CEO of Watson. "We believe that we have sound arguments that refute FDA's position and will seek the court's intervention to enable approval."

In a statement, FDA said it would not comment on ongoing litigation, and did not provide any information regarding its refusal of Watson's ANDA.


Read more:

FDA Law Blog - FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS

The Pink Sheet Daily - Watson Barred From Generic Actos Market; Mylan, Teva, Ranbaxy May Enter First


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