Alkermes Public Limited Company filed a Form 8-K on November 12, 2026, disclosing that two of its wholly-owned indirect subsidiaries entered into a confidential settlement and license agreement with Teva Pharmaceuticals, Inc. on November 6, 2026, resolving a patent infringement lawsuit over all dosage strengths of LYBALVI (olanzapine and samidorphan).

Key Highlights

  • Settlement date: Alkermes, Inc. and Alkermes Pharma Ireland Limited signed the Confidential Settlement and License Agreement with Teva Pharmaceuticals, Inc. on November 6, 2026.
  • Product at issue: The agreement covers all dosage strengths of LYBALVI (olanzapine and samidorphan), the subject of Teva's ANDA No. 220379.
  • License terms: Alkermes will grant Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited license to make, use, sell, and import Teva's ANDA products in the United States beginning November 12, 2039.
  • Pediatric exclusivity contingency: If Alkermes obtains pediatric exclusivity, the license start date shifts to May 12, 2040, or earlier under certain circumstances.
  • Dismissal filed: On November 9, 2026, the parties filed a joint Stipulation of Dismissal with Prejudice in the U.S. District Court for the District of New Jersey.
  • Regulatory review: The Settlement Agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

Alkermes and Teva Resolve LYBALVI ANDA Patent Dispute

According to the filing, Alkermes, Inc. and Alkermes Pharma Ireland Limited, both wholly-owned indirect subsidiaries of Alkermes plc (NASDAQ:ALKS), entered into the Settlement Agreement with Teva Pharmaceuticals, Inc. on November 6, 2026. The underlying lawsuit was brought by Alkermes against Teva in the U.S. District Court for the District of New Jersey, alleging infringement of certain Orange Book-listed United States patents for LYBALVI by Teva's ANDA No. 220379.

Pursuant to the Settlement Agreement, the filing discloses, Alkermes will grant Teva a non-exclusive, royalty-free, non-transferable, non-sublicensable limited license to make, have made, use, import, sell, and offer for sale Teva's products made under ANDA No. 220379 in the United States. The license period begins on November 12, 2039, or on May 12, 2040, if Alkermes obtains pediatric exclusivity, with earlier entry permitted under certain circumstances specified in the agreement.

The filing notes that on November 9, 2026, the parties submitted a joint Stipulation of Dismissal with Prejudice to dismiss the pending legal proceedings. The company disclosed that the Settlement Agreement remains subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The company also stated that the full text of the Settlement Agreement will be filed as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2026, and that the description in the 8-K "does not purport to be complete and is qualified in its entirety" by that full text.

What Was Disclosed

Alkermes plc reported that two subsidiaries settled a LYBALVI patent infringement case with Teva Pharmaceuticals, granting Teva a royalty-free, limited U.S. license starting November 12, 2039 (or May 12, 2040, with pediatric exclusivity), with a dismissal with prejudice filed November 9, 2026.