Today, Avanir Pharmaceuticals announced that an additional patent covering the company’s NUEDEXTA (dextromethorphan HBr and quinidine sulfate) product has been listed in the U.S. Food and Drug Administration’s Orange Book.
The additional patent, U.S. Patent number 8,227,484, entitled “Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders,” claims treatment methods for pseudobulbar affect or emotional lability using low-dose quinidine formulations of NUEDEXTA.
Pseudobulbar affect (PBA) patients have sudden, involuntary outbursts of crying or laughing without a stimulus to trigger those emotions. PBA can occur when certain neurologic diseases or injuries cause damage to the areas of the brain that control normal expression of emotion, resulting in disruption of brain signaling.
A listing in the FDA’s Orange Book will require any Abbreviated New Drug Application (ANDA) applicants seeking FDA approval for a generic version of NUEDEXTA to notify Avanir of their ANDA filing before they can obtain FDA approval.
Avanir’s additional patent was issued on July 24, 2012. The company now has three patents listed in the FDA Orange Book. They are patent number RE38,115, which will expire in 2016; patent number 8,227,484, which will expire in 2023; and patent number 7,659,282, which will expire in 2026. Additionally, Avanir has exclusive global rights to a family of patents and patent applications claiming methods for treating a variety of neurologic and psychiatric conditions using low-dose quinidine formulations of NUEDEXTA.
Avanir Pharmaceuticals is a biopharmaceutical company engaged in providing innovative medicines to patients with central nervous system disorders of high unmet medical need. The company has extensively invested in its pipeline, and Avanir is dedicated to advancing medicines that can significantly improve the lives of patients and their loved ones.
For more information, visit the company’s Web site at www.avanir.com
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