Alkermes (NASDAQ: ALKS) ends Amneal authorized generic VIVITROL pact
Rhea-AI Filing Summary
Alkermes plc terminated its Authorized Generic Product Supply Agreement with Amneal Pharmaceuticals LLC on July 6, 2026. The agreement had allowed Amneal to distribute a limited quantity of an authorized generic version of VIVITROL in the United States for a one-year term tied to a third-party ANDA product launch.
The arrangement provided Alkermes Pharma Ireland Limited with payment at a premium to fully burdened manufacturing cost plus a share of any net profits from sales. After Alkermes notified Amneal that certain terms were not met and allowed time to remedy, Amneal informed Alkermes that it did not wish to order any batches.
Alkermes did not incur any penalties from ending the agreement, and no further payments or obligations are owed by either party. Both sides also agreed to release all claims against each other and their affiliates related to the agreement.
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8-K Event Classification
Key Terms
Authorized Generic Product Supply Agreement regulatory
VIVITROL medical
Third Party ANDA Product Launch regulatory
Net Profits financial
fully burdened manufacturing cost financial
FAQ
What agreement did Alkermes (ALKS) terminate with Amneal?
Alkermes terminated its Authorized Generic Product Supply Agreement with Amneal Pharmaceuticals LLC. The deal covered U.S. distribution of a limited quantity of an authorized generic version of VIVITROL, including supply payments and a share of net profits for Alkermes Pharma Ireland Limited.
Did Alkermes (ALKS) incur penalties from ending the Amneal agreement?
Alkermes did not incur any penalties when the agreement with Amneal was terminated. After termination, no further payments or obligations are owed by Alkermes Pharma Ireland Limited or Amneal, limiting direct financial consequences from the decision as described in the disclosure.
What products were covered under the Alkermes–Amneal generic VIVITROL deal?
The agreement covered an authorized generic version of VIVITROL (naltrexone for extended-release injectable suspension). Amneal had rights to distribute and sell a limited quantity of this product in the United States for a one-year term linked to a third-party ANDA product launch.
Why did the Alkermes and Amneal agreement end early?
Alkermes notified Amneal that certain agreement terms had not been met and provided time to remedy. Before that period expired, Amneal informed Alkermes it did not wish to order any batches, leading to termination consistent with the contract’s conditions and rights.
What claims did Alkermes (ALKS) and Amneal release after termination?
Following termination, Alkermes and Amneal agreed to release any and all claims against each other. The release also covers their respective affiliates, successors, assigns, and other representatives for matters arising out of or related to the terminated agreement.
How was Alkermes to be compensated under the Amneal generic VIVITROL agreement?
Alkermes Pharma Ireland Limited was to receive payment at a premium to its fully burdened manufacturing cost for supplied product. It was also entitled to a share of any net profits realized from sales of the Amneal authorized generic VIVITROL product in the United States.