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# Par Sues FDA Over Colchicine Exclusivity Forfeiture
- URL: https://www.fdaweb.com/par-sues-fda-over-colchicine-exclusivity-forfeiture/
- Published: 2016-10-03T12:00:00.000Z
- Updated: 2026-09-14T21:36:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136968

Par Pharmaceutical has filed a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Par’s eligibility for 180-day exclusivity for a generic copy of Takeda’s gout drug Colcrys (colchicine) tablets. On 9/28, the agency informed Par for the first time that it had forfeited eligibility for 180-day exclusivity. It told the company that “\[a\]lthough Par has maintained a paragraph IV certification with respect to the ’648 patent and the ’297 patent, it has not maintained an uninterrupted paragraph IV certification with respect to any claims within these patents.” In its [complaint](http://www.fdaweb.com/download.php?file=4860700-0--16586.pdf), Par contends that it maintained uninterrupted Paragraph IV certification with respect to at least claims one and seven of the ’648 patent.

Par says FDA has failed to provide a lawful basis for its decision. It asks the court to declare the agency’s decision was arbitrary, capricious and contrary to law. It also asks for an injunction directing FDA not to approve any other ANDA for colchicine tablets prior to the approval of Par’s ANDA.