ALISO VIEJO, Calif., Aug. 3, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that an additional patent covering Avanir's NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) product has been listed in the U.S. Food and Drug Administration's (FDA) Orange Book.
The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant, seeking FDA approval for a generic version of NUEDEXTA prior to expiration of the patent, to notify Avanir of its ANDA filing before it can obtain FDA approval.
The additional patent, U.S. Patent number 8,227,484, entitled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders," claims methods for treating pseudobulbar affect or emotional lability using low-dose quinidine formulations of NUEDEXTA. This additional patent, whose allowance was previously announced by Avanir on July 2, 2012, issued on July 24, 2012.
Avanir Pharmaceuticals now has three patents listed in the FDA Orange Book:
- Patent number: RE38,115 which expires in 2016
- Patent number: 8,227,484 which expires in 2023
- Patent number: 7,659,282 which expires in 2026
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