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Scilex Holding Company (NASDAQ:SCLX) announced Tuesday that a U.S. district court in Delaware gave the final go-ahead for a settlement agreement between the company and Japanese drugmaker Takeda (NYSE:TAK) regarding a generic therapy targeted at an arthritic condition called gout.
The dispute started in November when Takeda (TAK) alleged that Scilex (SCLX) infringed its patents related to its colchicine product, Colcrys, when the company sought FDA approval to market its rival product, Gloperba, under a revised label for gout.
In March, the two parties reached a settlement under which Takeda (TAK) granted the company a non-exclusive license to some of its Colcrys-related patents.
The deal was subject to court approval and the review of the Federal Trade Commission and the U.S. Department of Justice.
The 45-day review period expired, and the court issued a judgment on May 3, 2024, approving the settlement, Scilex (SCLX) said.
The company has submitted a copy of the judgment to the FDA, seeking to convert its tentative approval of Gloperba label expansion into a final approval.
“With the resolution of this patent issue, Scilex Pharma believes that it has satisfied all requirements for final FDA approval of the expanded Gloperba label,” SCLX said.
