Avanir sues Par and Actavis over Nuedexta patent infringement

California, USA-based Avanir Pharmaceuticals (Nasdaq: AVNR) has filed law suits in the US District Court for the District of Delaware against Par Pharmaceutical (NYSE: PRX) and Icelandic generic drugmaker Actavis with respect to patent infringement of the firm’s Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), an agent launched in the USA for the treatment of pseudobulbar affect (pathological crying or laughing) in late January 2011.

The law suits were filed in response to Abbreviated New Drug Applications filed by Par and Actavis seeking to market and sell generic versions of the currently approved dose of Nuedexta prior to the expiration of US patents 7,659,282 and RE38,115 (which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations [Orange Book]). Avanir filed the suits on the basis that Par's and Actavis' proposed generic products infringe certain patents held by Avanir.

In accordance with the Hatch-Waxman Act, as a result of having filed law suits within 45 days of the Paragraph IV certification notices, Food and Drug Administration approval of the ANDAs will be stayed until the earlier of either 30 months from the company's receipt of the notices or a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. Avanir intends to vigorously enforce its patent rights.