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Adamas grants license to Sandoz under patent litigation settlement

Adamas Pharmaceuticals Inc. granted a non-exclusive license of Gocovri to Novartis AG's generics unit Sandoz Inc., settling their ongoing patent litigation.

The company's litigation involved Sandoz's abbreviated new drug application with the U.S. Food and Drug Administration to market a generic version of Gocovri, or amantadine, extended-release capsules. This type of application seeks approval for a generic version of an existing licensed medication or approved drug.

Adamas' Gocovri was approved by the FDA in 2017 for the treatment of involuntary movements known as dyskinesia, associated with a commonly prescribed Parkinson's disease treatment levodopa.

Under the settlement, Adamas granted Sandoz a non-exclusive license to make, use, sell, offer to sell and import the products that are the subject of Sandoz's abbreviated new drug application as of March 4, 2030, or earlier. This includes a potential accelerated license date if the unit sales of Gocovri in the 12-month period ending July 31, 2025, or any subsequent 12-month period decline by a specific percentage are below unit sales of the drug in the year ended Dec. 31, 2019.

Sandoz submitted a certification for a 180-day first filer exclusivity granting its Gocovri generic version to enter the market on March 4, 2030, which is less than nine months prior to the Dec. 2, 2030 expiration of the last-to-expire patent.