SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|Item 8.01||Other Events.|
As previously disclosed, on June 23, 2022, Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”), a subsidiary of Avadel Pharmaceutical plc (the “Company”), filed a Renewed Motion for Judgment on the Pleadings, with respect to its counterclaim against Jazz Pharmaceuticals, Inc. (“Jazz”), seeking to have U.S. Patent No. 8731963 (the “REMS Patent”) de-listed from the U.S. Food and Drug Administration’s (“FDA”) Orange Book. The United States District Court for the District of Delaware (the “Delaware Court”) held a hearing on that motion and on November 18, 2022, the Delaware Court issued its written opinion ordering Jazz to request delisting of the REMS Patent. Jazz subsequently appealed the Delaware Court’s decision to the U.S. Court of Appeals for the Federal Circuit, which stayed the order. On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit denied Jazz’s appeal of the Delaware Court’s decision and lifted its stay of the Delaware Court’s decision ordering Jazz to de-list the REMS Patent within 14 days of today’s decision. The Company intends to seek final FDA approval for LUMRYZ upon Jazz filing the mandated request for de-listing of the REMS Patent from FDA’s Orange Book.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: February 24, 2023||AVADEL PHARMACEUTICALS PLC|
|By:||/s/ Jerad G. Seurer|
|Name:||Jerad G. Seurer|
|Title:||General Counsel & Corporate Secretary|