AVDL - Avadel seeks full FDA approval for sleep therapy as Jazz loses patent appeal
- Avadel Pharmaceuticals ( NASDAQ: AVDL ) announced Friday that the company intends to seek final FDA approval for its sleep disorder therapy Lumryz as Jazz Pharma ( NASDAQ: JAZZ ) lost its appeal related to a patent dispute.
- The FDA has already granted tentative approval for Lumryz to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
- However, Jazz ( JAZZ ) which markets Xyrem for the same indication, has disputed the IP rights for Lumryz based on the U.S. patent No. 8731963 (REMS Patent), listed in the FDA’s Orange Book.
- In November, a district court in Delaware ordered Jazz ( JAZZ ) to request de-listing of the REMS Patent from the FDA’s Orange Book, and the company later appealed the decision.
- On Friday, the appeal court denied the appeal, ordering Jazz ( JAZZ ) to de-list the REMS patent within 14 days of the court decision.
- Seeking Alpha contributor Out of Ignorance likened the patent dispute between Avadel ( AVDL ) and Jazz ( JAZZ ) to a “David vs. Goliath match-up.”
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Avadel seeks full FDA approval for sleep therapy as Jazz loses patent appeal