Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has entered into a settlement agreement with Actavis South Atlantic LLC and Actavis, Inc. (collectively, "Actavis") to resolve pending patent litigation in response to Actavis' abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules.
The settlement agreement grants Actavis the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances. The parties have also agreed to file a stipulation and order of dismissal with the United States District Court for the District of Delaware which will conclude this litigation with respect to Actavis. The settlement does not end Avanir's ongoing litigation against the other three ANDA filers.
In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the Department of Justice where it is subject to review.
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