Avanir agrees settlement with Sandoz over Nuedexta

14 August 2013

US drugmaker Avanir Pharmaceuticals (Nasdaq: AVNR) has entered into a settlement agreement with Swiss drug major Novartis’ (NOVN: VX) generics unit Sandoz over its Abbreviated New Drug Application for a generic version 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 agreement grants Sandoz 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 Sandoz. The settlement does not end Avanir's ongoing litigation against four other ANDA filers.

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