Alkermes unit signs Vivitrol authorized generic supply deal with Amneal, sues three generic filers
On September 9, 2025, Alkermes subsidiary APIL signed an authorized generic supply agreement with Amneal Pharmaceuticals for a generic version of VIVITROL in the United States. The same filing reports patent infringement lawsuits over LYBALVI filed in August and early September 2025 against Teva, Apotex and MSN, which trigger FDA approval stays under the Hatch-Waxman Act.
Key points
- Amneal may distribute the authorized generic VIVITROL for a one-year term starting on a third-party ANDA product launch, with rights ending if no launch occurs within 90 days after January 15, 2027, unless an earlier date applies.
- APIL supply volume to Amneal is capped at approximately 15% of 2024 VIVITROL unit sales, with supply priced at a premium to APIL's fully burdened manufacturing cost and net profits shared.
- Lawsuits were filed on August 15, August 27, September 5 and August 28, 2025, against Teva, Apotex and MSN over LYBALVI patents expiring between 2032 and 2041.
- The AG agreement will be filed as an exhibit to the Form 10-Q for the quarter ending September 30, 2025.
The filing
Written by AI (Anthropic Claude, claude-haiku-5-5) on Nov 8, 2026, 12:57 AM ET, from the text of the filing and its press-release exhibits only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 12, 2025.
Briefs are written by AI from the filing text (each brief's own page names the model) and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the model's reading of the filing for shareholders, not a price forecast. Not investment advice.