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Alkermes (NASDAQ: ALKS) ends Amneal authorized generic VIVITROL pact

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

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.

Positive

  • None.

Negative

  • None.
Item 1.02 Termination of a Material Definitive Agreement Business
A significant contract was terminated, which may affect business operations or revenue.
Authorized Generic Product Supply Agreement regulatory
"terminated the previously disclosed Authorized Generic Product Supply Agreement entered into on September 9, 2025"
VIVITROL medical
"an authorized generic version of VIVITROL® (naltrexone for extended-release injectable suspension)"
Third Party ANDA Product Launch regulatory
"for a one-year term beginning on the date of a Third Party ANDA Product Launch"
Net Profits financial
"and a share of any Net Profits realized from the sales of the Amneal AG Product"
Net profits are the amount of money a company keeps after paying every business cost — operating expenses, interest, taxes and any one‑time charges — like the cash left in your wallet after covering all bills. For investors, net profit shows whether a company’s core activities actually generate surplus value, and it helps gauge financial health, potential dividends, and how attractively the business may be valued compared with peers.
fully burdened manufacturing cost financial
"payment for the supply of the Amneal AG Product at a premium to APIL’s fully burdened manufacturing cost"
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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.

False0001520262Alkermes plc.00015202622026-07-062026-07-06

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): July 6, 2026

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-35299

 

98-1007018

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

 

Connaught House, 1 Burlington Road

Dublin 4, Ireland D04 C5Y6

(Address of principal executive offices)

 

Registrant's telephone number, including area code: + 353-1-772-8000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Ordinary shares, $0.01 par value

 

ALKS

 

Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


 

Item 1.02. Termination of a Material Definitive Agreement.

On July 6, 2026, Alkermes plc (the “Company”) and Amneal Pharmaceuticals LLC (“Amneal”) terminated the previously disclosed Authorized Generic Product Supply Agreement entered into on September 9, 2025 (the “Agreement”). Capitalized terms used and not otherwise defined herein shall have the meanings ascribed to them in the Agreement.

Under the Agreement, Alkermes Pharma Ireland Limited (“APIL”), 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® (naltrexone for extended-release injectable suspension) for a one-year term beginning on the date of a Third Party ANDA Product Launch (such authorized generic product, the “Amneal AG Product”) in exchange for payment for the supply of the Amneal AG Product at a premium to APIL’s fully burdened manufacturing cost and a share of any Net Profits realized from the sales of the Amneal AG Product. The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.

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 such period, that it did not wish to order any Batches under the Agreement. The Company did not incur any penalties in connection with the termination of the Agreement and, after the termination, no further payments or obligations are owed by APIL or Amneal under the Agreement. Further, in connection with this termination, 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.

 

2


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ALKERMES PLC

 

 

Date: July 7, 2026

By:

 

/s/ David J. Gaffin

 

 

 

David J. Gaffin

 

 

 

Secretary

 

3


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