Otsuka Pharmaceutical Co., Ltd.

August 13, 2015

Otsuka Pharmaceutical's Subsidiary Avanir Pharmaceuticals Prevails in NUEDEXTA® Patent Appeal Maintaining Exclusivity Through 2026 in the U.S.

Otsuka Pharmaceutical Co. Ltd. announces that Avanir Pharmaceuticals, Inc., a U.S. subsidiary based in Aliso Viejo, California, received a favorable ruling from the U.S. Court of Appeals regarding NUEDEXTA®. The Federal Circuit Court upheld the validity and enforceability of Avanir's patents covering NUEDEXTA (U.S. patent numbers 7,659,282 and 8,227,484). The decision confirms patent protection in the U.S. for NUEDEXTA until 2026.

The Appeals Court ruling affirmed the April 2014 decision upholding the two patents' validity by the U.S. District Court for the District of Delaware in a lawsuit brought by Avanir against the generic manufacturer Par Pharmaceuticals.

NUEDEXTA is an innovative combination of two well-characterized components, dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. Dextromethorphan acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with pseudobulbar affect (PBA) is unknown.

PBA occurs secondary to a variety of otherwise unrelated neurologic 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.

NUEDEXTA is the only U.S. FDA-approved product for the treatment of pseudobulbar affect.