Avanir Pharma patent settlement with Wockhardt

USA-based Avanir Pharmaceuticals (Nasdaq: 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 seeking approval to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules.

Nuedexta was launched in the USA for the treatment of pseudobulbar affect (pathological crying or laughing) in late January 2011, and was recently approved for this indication in Europe (The Pharma Letter June 26).

The settlement deal grants Wockhardt 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 US District Court for the District of Delaware which will conclude this litigation with respect to Wockhardt. The settlement does not end Avanir's ongoing litigation against the other two ANDA filers.