Adamas Announces Settlement of Patent Litigation with Sandoz

Adamas has entered into a Settlement Agreement with Sandoz resolving its ongoing litigation concerning Sandoz’s Abbreviated New Drug Application (ANDA) seeking approval by the U.S. Food and Drug Administration (FDA) to market a generic version of GOCOVRI® (amantadine) Extended Release Capsules.

"I am pleased to announce this settlement agreement with Sandoz, which demonstrates the strength of Adamas’ intellectual property and provides both parties with certainty," said Neil F. McFarlane, Chief Executive Officer of Adamas Pharmaceuticals, Inc. "With the launch of GOCOVRI still in its early stages, this agreement facilitates our ability to maximize the number of patients who may benefit from GOCOVRI."

Under the settlement agreement, Adamas grants Sandoz a non-exclusive license to make, use, sell, offer to sell and import the products that are the subject of Sandoz’s ANDA as of March 4, 2030, or earlier in certain circumstances, including a potential for an 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 specified percentage below the unit sales of GOCOVRI in the year ended December 31, 2019. The agreed-upon entry date for Sandoz’s generic version of GOCOVRI of March 4, 2030 is less than nine months prior to the December 2, 2030 expiration of the last-to-expire patent, on which Sandoz submitted a certification qualifying it for 180-day first filer exclusivity.

In accordance with the Settlement Agreement, the parties will submit a joint stipulation and order to the United States District Court for the District of New Jersey, and the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice. Upon entry of the joint stipulation and order, this Settlement Agreement will conclude all patent litigation brought to date by Adamas against generic pharmaceutical companies that filed an ANDA seeking approval to market generic versions of GOCOVRI prior to the expiration of the patents listed in the Orange Book.

GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

Taken once-daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

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