Alkermes faces direct-purchaser antitrust class action over Vivitrol patent

Alkermes plc (Nasdaq: ALKS) disclosed in its 10-Q filed July 28, 2026 that Value Drug Company has sued two of its subsidiaries, Alkermes, Inc. and Alkermes Pharma Ireland Limited (APIL), for antitrust violations in the U.S. District Court for the District of Massachusetts. The company's 10-K filed February 25, 2026 dates the complaint to October 2, 2025. Neither filing gives a case number. The complaint was filed for a putative class of direct purchasers of Vivitrol, Alkermes' once-monthly injectable medication for alcohol dependence and for the prevention of relapse to opioid dependence.

The defendants are Alkermes, Inc. and APIL. The filings name no individual defendants, and they do not name Alkermes plc itself as a defendant.

The case

The complaint alleges that Alkermes' U.S. Patent No. 7,919,499, which relates to Vivitrol, was fraudulently obtained, improperly listed in the FDA's Orange Book and wrongfully enforced. The plaintiff claims those steps delayed market entry for generic forms of Vivitrol. The filings do not give a class period.

The lawsuit seeks unspecified money damages plus interest, reasonable attorneys' fees and other costs.

The 10-K describes patent challenges to the same patent at the U.S. Patent and Trademark Office. In December 2024, Argentum Pharmaceuticals LLC asked for an ex parte reexamination of certain claims of U.S. Patent No. 7,919,499, which the 10-K says covers Vivitrol. In January 2025, Apotex Inc. petitioned for inter partes review of certain claims of the same patent. The office discretionarily denied institution of the review in July 2025. In October 2025 it confirmed the validity of the claims challenged in the reexamination and found several additional claims Alkermes filed patentable. The 10-K says both challenges were resolved in Alkermes' favor.

Defendants

Alkermes, Inc. and Alkermes Pharma Ireland Limited are both wholly owned subsidiaries of Alkermes plc, according to the 10-Q. No officers or directors are named in the lawsuit as the filings describe it.

Where it stands

On December 19, 2025, Alkermes, Inc. and APIL filed a motion to dismiss the complaint in the Massachusetts court, according to the 10-K. The 10-Q, filed July 28, 2026, reports no ruling on that motion, no class certification and no discovery schedule. Alkermes says it "intends to vigorously defend itself in this matter."

The 10-K also describes licenses that let generic Vivitrol onto the market. Under a confidential settlement and license agreement from August 2023, Alkermes granted Teva a non-exclusive, royalty-free license to sell a generic Vivitrol in the U.S. beginning on January 15, 2027, or earlier under certain circumstances. A July 2019 settlement with Amneal Pharmaceuticals LLC gives Amneal a license starting on the earlier of that date, sometime in 2028 or earlier under certain circumstances. The 10-K does not say whether these agreements bear on the antitrust claims.

Why it matters to shareholders

The complaint seeks unspecified damages, so neither filing gives an amount at stake. The 10-Q says that at June 30, 2026 there were no potential material losses from claims or legal proceedings that the company determined were probable. For claims that are reasonably possible, it says no estimable loss or range of loss can be made. The 10-Q discloses no accrual for this case. The 10-K adds that the earlier patent challenges required expenditure of time, effort and resources even though they ended in Alkermes' favor.

Related matters

The same legal note covers the Lybalvi patent suits that Alkermes' subsidiaries filed against Teva, Apotex and MSN entities, a civil investigative demand from a U.S. state governmental authority that the company says it is cooperating with, and the Acorda arbitration dispute, in which the Second Circuit ruled for Alkermes on July 15, 2026.

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