Alkermes and Amneal terminate VIVITROL authorized generic supply deal
The companies ended their September 2025 agreement on July 6, 2026, after Amneal declined to order product under the arrangement.
Alkermes plc disclosed in an 8-K filing that on July 6, 2026, it and Amneal Pharmaceuticals LLC terminated the previously disclosed Authorized Generic Product Supply Agreement entered into on September 9, 2025.1
The original agreement had covered a limited slice of the market for VIVITROL, Alkermes's extended-release naltrexone injection. Under its terms, Alkermes Pharma Ireland Limited, a wholly-owned indirect subsidiary of the company, granted Amneal certain rights to distribute and sell in the United States a limited quantity of an authorized generic version of VIVITROL for a one-year term beginning on the date of a Third Party ANDA Product Launch, in exchange for payment for the supply of the product at a premium to APIL's fully burdened manufacturing cost and a share of any net profits realized from the sales of the product.1
The filing describes the sequence leading to termination. After the company notified Amneal that it had not met certain terms of the agreement, which Amneal had a period of time to remedy, Amneal notified the company, prior to the expiry of that period, that it did not wish to order any batches under the agreement.1
Alkermes stated that it did not incur any penalties in connection with the termination, and that after the termination, no further payments or obligations are owed by APIL or Amneal under the agreement.1 The filing also noted that the parties agreed to release any and all claims against one another and their respective affiliates, successors, assigns and other representatives arising out of or related to the agreement.1
The original agreement text had previously been filed as an exhibit to Alkermes's quarterly report for the period ended September 30, 2025.
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