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Pharmaceuticals / Regulatory Affairs / Commercial Operations

Par Sues FDA Over 180-Day Exclusivity Denial for Colcrys Generic

Oct. 10, 2016

Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics.

The company contends that the FDA improperly denied the generic gout treatment the exclusivity given to the first copycat version of a name-brand treatment.

In September, the FDA told the company that it had forfeited its eligibility for 180 days of marketing exclusivity because the company filed an incomplete patent certification.

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