Brand Firm Avanir Wins Generic Patent Challenge to Nuedexta

Avanir Pharmaceuticals said last week that a federal judge had ruled against generic firms Par Pharmaceuticals and Impax Labs in their challenge to make versions of Avanir’s pseudobulbar affect drug Nuedexta.

After a six-day trial, the U.S. District Court for the District of Delaware upheld the validity of Avanir’s 282 and 484 patents on Nuedexta (dextromethorphan hydrobromide/quinidine sulfate), and ruled that the generics’ proposed ANDA formulations infringed on both of them.

“We are very pleased with the court's decision, as it confirms our continued belief in the strength of the patents covering Nuedexta,” Avanir President and CEO Keith Katkin said in a statement.

Katkin also said the decision provides the company with 12-plus years of market exclusivity for Nuedexta. According to the Avanir, Nuedexta is the only FDA-approved treatment for pseudobulbar affect, a medical condition characterized by sudden and uncontrollable episodes of crying or laughing.

In September 2013, Avanir said it had entered into a settlement agreement granting manufacturer Wockhardt the right to sell a generic version of Nuedexta before its last protective patent expires on Aug. 15, 2026. — Neal Learner

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