Avanir and Wockhardt settle Nuedexta patent dispute

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Avanir and Wockhardt settle Nuedexta patent dispute

Generics/News | Posted 20/09/2013 0 Post your comment

US-based Avanir Pharmaceuticals (Avanir) announced on 6 September 2013 that it had entered into a settlement agreement with Wockhardt USA, the US subsidiary of India-based generics maker Wockhardt, regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate).

The settlement resolves patent litigation due to Wockhardt’s abbreviated new drug application (ANDA) for its generic versions of Avanir’s Nuedexta capsules.

Nuedexta is used for the treatment of pseudobulbar affect (PBA), which occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden and frequent episodes of laughing and/or crying.

Avanir only received FDA approval for Nuedexta in 2010, so it is still a little early for patent challenges. But perhaps the fact that the drug combines two old drugs has given generics manufacturers more scope to challenge the patent. Nuedextra combines dextromethorphan and quinidine. Dextromethorphan affects the signals in the brain that trigger cough reflex, and is generally used as a cough suppressant. Quinidine, on the other hand, affects the way that the heart beats and is generally used in people with certain heart rhythm disorders.

The deal means that Wockhardt will be able to start selling its generic versions of Nuedexta on 30 July 2026, when the US patent on Nuedexta expires, or earlier under certain circumstances. Avanir also settled patent litigation with Actavis and Sandoz in August and September 2013, respectively, but states that the company has ongoing litigation against two other ANDA filers.

In compliance with US law, the settlement agreement has to be submitted to the US Federal Trade Commission and the Department of Justice where it is subject to review.

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Source: Avanir, Zachs