Amneal, Actavis settle generic Rytary litigation

BY David Salazar

Amneal Pharmaceuticals and Actavis recently settled litigation over Actavis’ generic of Rytary, a Parkinson’s disease treatment from Impax, now Amneal’s specialty pharma division. The litigation had been pending in a New Jersey District Court since Actavis filed an Abbreviated New Drug Application for a generic of the product.

Under the settlement, Ameal will grant Actavis a license to sell its generic Rytary on July 31, 2025, or earlier under certain circumstances. The launch is contingent on Food and Drug Administration approval of Actavis’ generic. The companies did not disclose additional details about the settlement.

“We are pleased to have settled the outstanding litigation with Actavis regarding Rytary,” Amneal president and CEO Rob Stewart said “We will continue to defend our existing patents and explore opportunities to further expand our intellectual property portfolio around Rytary.”

Amneal still has separate litigation pending with both Sandoz and Zydus Pharmaceuticals about both companies’ proposed Rytary generics.


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