US-based Avanir Pharmaceuticals (AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's Nuedexta capsules.
As part of the deal, Wockhardt gets the right to start selling a generic version of Nuedexta on 30 July 2026, or earlier under certain circumstances.
Both the parties have also agreed to file a stipulation and order of dismissal with the US District Court of Delaware which will end the litigation with respect to Wockhardt.
According to Avanir, the settlement does not end its ongoing litigation against the other two ANDA filers.
The settlement agreement, which will be in compliance with US law, will be submitted to the US Federal Trade Commission and the Department of Justice where it is subject to review.
Nuedexta is used for the treatment of pseudobulbar affect (PBA), which occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying.
The drug has been developed by combining two components including dextromethorphan hydrobromide, an ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.
