Fed­er­al Cir­cuit court halts delist­ing of Jazz nar­colep­sy drug patent from the Or­ange Book

The US Court of Ap­peals for the Fed­er­al Cir­cuit yes­ter­day or­dered a halt to the delist­ing of a key patent for Jazz Phar­ma­ceu­ti­cals’ nar­colep­sy drug in the FDA’s Or­ange Book, re­vers­ing a Delaware dis­trict court judge’s de­ci­sion last month to re­move the patent from the Or­ange Book.

The case at hand in­volves Avadel CNS Phar­ma­ceu­ti­cals, which has sought to delist one of Jazz Phar­ma­ceu­ti­cals’ patents re­lat­ed to the method for dis­trib­ut­ing its block­buster nar­colep­sy drug Xyrem as part of a re­strict­ed dis­tri­b­u­tion sys­tem un­der its REMS.

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