ALISO VIEJO, Calif., April 30, 2014, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. District Court for the District of Delaware has ruled in favor of Avanir in the company's patent infringement lawsuit against Par Pharmaceuticals, Inc. and Impax Laboratories, Inc. in conjunction with their Abbreviated New Drug Applications ('ANDAs') for generic versions of NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules for the treatment of pseudobulbar affect.
Following a six day bench trial in the District of Delaware, Judge Leonard P. Stark issued a ruling upholding the validity of the patents covering NUEDEXTA (US Patent Nos. RE38,115, 7,659,282 (the "'282 patent") and 8,227,484 (the "'484 patent"), and holding that the proposed ANDA formulations infringe the claims of the '282 patent and '484 patent.
"We are very pleased with the Court's decision, as it confirms our continued belief in the strength of the patents covering NUEDEXTA," said Keith A. Katkin, president and chief executive officer of Avanir. "Our focus remains on making NUEDEXTA available to patients suffering from the debilitating condition of PBA. This decision provides twelve-plus years of market exclusivity for NUEDEXTA."
NUEDEXTA remains the only FDA-approved product for the treatment of pseudobulbar affect.About NUEDEXTANUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. NUEDEXTA Important Safety InformationNUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.