Avanir Pharma prevails in Nuedexta patent appeal in USA

19 August 2015

Japanese drugmaker Otsuka Pharmaceutical (TYO4768) says its US subsidiary Avanir Pharmaceuticals has received a favorable ruling from the US Court of Appeals regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate).

The Federal Circuit Court upheld the validity and enforceability of Avanir’s patents covering Nuedexta, the only US Food and Drug Administration-approved product for the treatment of pseudobulbar affect, confirming patent protection in the USA for the drug until 2026.

The Appeals Court ruling affirmed the April 2014 decision upholding the two patents’ validity by the US District Court for the District of Delaware in a lawsuit brought by Avanir against the generic manufacturer Par Pharmaceuticals.

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