Avanir, Sandoz Settle Nuedexta Patent Litigation

Case Filed: May 30, 2013

Case Closed: Aug 20, 2013

Court: Delaware District Court

Judge: Leonard P. Stark

Case Summary:

Avanir Pharmaceuticals filed a patent infringement suit against Sandoz concerning its filing of abbreviated new drug application with the FDA with its intent to commercialize a generic version of Nuedexta®, which is used to treat pseudobulbar affect. The patents-in-suit were:

•       RE38115 entitled ‘Dextromethorphan and an oxidase inhibitor for treating intractable conditions’ issued on May 06, 2003 and expiring* by Sep 22, 2014
•     US8227484 entitled ‘Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders’ issued on Jul 24, 2012 and expiring* by Jul 17, 2023
•   US7656282 entitled ‘Batteryless tire inflation pressure detecting apparatus with improved power-saving configuration’ issued on Feb 02, 2010 and expiring* by May 15, 2026

According to the complaint, Avanir is the assignee of the patents-in-suit. Plaintiffs alleged that Sandoz’s abbreviated new drug application (ANDA) no. 203538 to manufacture generic Nuedexta capsules, filed with the FDA had infringed the ‘115, ‘484 and ‘282 patents all of which cover the composition of the drug. Avanir currently holds+ the approved New Drug Application (NDA) no. 21-879 (source: MaxVal’s Patent Marker), approved by FDA on October 2010 for dextromethorphan hydrobromide/quinidinesulfate capsules, which it sells sunder the trade name Nuedexta®.  It is used to treat involuntary outbursts of crying or laughing in people with certain neurological disorders, including multiple sclerosis and amyotrophic lateral sclerosis. Avanir wanted judgment that Sandoz has infringed the patents and an injunction barring Sandoz’s products until expiration of the patents, along with costs and expenses.

The parties having agreed upon a settlement subsequently filed a stipulation of dismissal, pursuant to which the Court ordered all claims, defenses, and counterclaims dismissed without prejudice, thereby concluding this litigation with respect to Sandoz. 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 settlement does not end Avanir's ongoing litigation against the other four ANDA filers (Par Pharmaceutical, Wockhardt, Impax Laboratories and Watson).

See 1:13-cv-00961 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents

+ Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.