Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz

Avanir Pharmaceuticals, Inc.

today announced that it has entered into a settlement agreement with Sandoz, Inc. to resolve pending patent litigation in response to Sandoz's abbreviated new drug application (ANDA) seeking approval to market generic versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules. The settlement agreement grants Sandoz the right to begin selling a generic version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances. The parties have also agreed to file a stipulation and order of dismissal with the United States District Court for the District of Delaware which will conclude this litigation with respect to Sandoz. The settlement does not end Avanir's ongoing litigation against the other four ANDA filers. In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the Department of Justice where it is subject to review. About NUEDEXTA 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. 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 Information NUEDEXTA 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. NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you. NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose. The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness. These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com. About Avanir Pharmaceuticals, Inc. Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.