Avanir Settles With Ranbaxy Over Nuedexta Generic

July 1, 2014

Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA).

Terms of the agreement are the same as ones California-based Avanir has struck with five of the six generic firms to challenge patents on the drug: Wockhardt, Actavis, Watson (now Sandoz), Impax and finally Ranbaxy.

Each firm will be able to market a generic version of Nuedexta (dextromethorphan hydrobromide/quinidine sulfate capsules) by July 30, 2026, shortly before the drug’s last patent expires Aug. 15 of that year. The generics firms may be able to market their own versions sooner under certain circumstances, which have not be disclosed.

Only a patent challenge from generics firm Par Pharmaceuticals is still being litigated. Like its generics competitors, Par had sought to challenge Nuedexta’s ’484 patent, which expires in 2023, and the ’282 patent, which expires in 2026.

Avanir won FDA approved for Nuedexta in 2010 and launched the drug in February 2011. PBA is characterized by involuntary and frequent laughing or crying, and often is seen in patients with underlying neurological disorders.

In May, a federal judge ruled against a patent challenge from Par Pharmaceuticals and Impax Labs. Par is appealing.

The drug generated $19 million in gross product sales in the third quarter of 2013, according to Avanir. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.