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NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.
Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.
Amneal earlier this year applied for approval of generic colchicine in gout patients, asserting that Takeda's patents covering the gout indication were invalid and triggering a lawsuit from Takeda, but later withdrew the application. The latest lawsuit relates to an effort by Amneal to win approval for the drug as a treatment for familial Mediterranean fever, or FMF, a rare genetic disease.