Alkermes plc announced that the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. ("Teva") to resolve the ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey related to VIVITROL® (naltrexone for extended-release injectable suspension). Pursuant to the terms of the settlement agreement, the company has granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.
Additional details regarding the settlement agreement were not disclosed. The company and Teva will submit the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice.
This patent litigation was initiated by the company in September 2020 in response to Teva's abbreviated new drug application seeking United States Food and Drug Administration approval of a generic version of VIVITROL in the United States prior to the expiration of Alkermes' U.S. Patent No. 7,919,499, an Orange Book-listed patent for VIVITROL that expires in 2029. The parties completed a trial in March 2023. In connection with the settlement, the company and Teva will file a proposed Stipulated Consent Judgment and Injunction with the U.S. District Court for the District of New Jersey requesting that the Court dismiss the pending litigation between the parties.
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