09 September 2013 | News | By BioSpectrum Bureau
Singapore: US based Avanir Pharmaceuticals has entered into a settlement agreement with India's 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 (dextromethorphan hydrobromide/quinidine sulfate) capsules.
The settlement agreement 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 United States District Court for the District of Delaware which will conclude this litigation with respect to Wockhardt.
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.