Avadel Pharmaceuticals Announces Favorable Ruling Regarding Sleep Disorder Drug Patent

  • Avadel Pharmaceuticals plc AVDL announced that the United States District Court for the District of Delaware ordered Jazz Pharmaceuticals PLC JAZZ to delist U.S. Patent No. 8731963 (the REMS Patent) from the FDA Orange Book
  • With this decision, Avadel seeks to accelerate the FDA's final approval for Lumryz, a once-at-bedtime formulation of sodium oxybate for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
  • In July, Lumryz received tentative approval from the FDA, with potential final approval pending the disposition of the REMS Patent. 
  • Price Action: Avadel Cuts Workforce, Optimizes Cost Structure.
  • In October, a Markman hearing was held in which Avadel renewed its request for expedited consideration of its pending motion to have the REMS Patent delisted from the FDA's Orange Book. 
  • The Delaware Court granted that request and held a hearing on that motion. 
  • Avadel is currently evaluating the long-term safety and tolerability of Lumryz in the open-label RESTORE clinical study. 
  • Price Action: AVDL shares are 0.12% lower at $8.01 during premarket trading on Monday.
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