Impax confirms patent challenge for generic Nuedexta

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempts to market a generic pseudobulbar affect treatment.

Impax said that Avanir Pharmaceuticals, Avanir Holding Co. and the Center for Neurologic Study filed a patent infringement suit in the U.S. District Court of Delaware in connection with Impax's attempt to market a generic version of Nuedexta capsules (dextromethorphan hydrobromide and quinidine sulfate) in the 20-mg/10-mg strength.

The generic drug maker recently submitted an abbreviated new drug application containing a paragraph IV certification to the Food and Drug Administration, which was accepted by the regulatory agency.

U.S. sales of Nuedexta were approximately $3.6 million for the seven-month period ended in July, according to Wolters Kluwer Health data.

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