Avanir Pharmaceuticals has settled pending patent litigation concerning Sandoz's abbreviated new drug application (ANDA) to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules.
Under the settlement, Sandoz gained right to begin selling a generic version of Nuedexta on July 30, 2026, or earlier under certain circumstances.
A stipulation and order of dismissal will be filed with the US District Court for the District of Delaware to conclude the litigation with respect to Sandoz.
The settlement agreement, which does not end Avanir's ongoing litigation against the other four ANDA filers, will be submitted to the US Federal Trade Commission and the Department of Justice where it is subject to review.
Nuedexta is a combination of dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations, and acts on sigma-1 and NMDA receptors in the brain.
Nuedexta's mechanism of action exerting therapeutic effects in patients with PBA is unknown.