Court KOs REMS-re­lat­ed patent list­ing for Jazz nar­colep­sy drug

A Delaware dis­trict court said say­onara to a Jazz Phar­ma­ceu­ti­cals patent re­lat­ed to the dis­tri­b­u­tion sys­tem for its block­buster nar­colep­sy drug Xyrem.

The case at hand in­volves Avadel CNS Phar­ma­ceu­ti­cals, which sought to delist the patent in ques­tion, as it re­lat­ed to its re­strict­ed dis­tri­b­u­tion sys­tem un­der its REMS.

Af­ter list­ing the patent in the Or­ange Book, Jazz filed a patent in­fringe­ment law­suit against Avadel, trig­ger­ing a 30-month stay that blocks fi­nal FDA ap­proval of Avadel’s com­pet­ing (and ten­ta­tive­ly ap­proved) nar­colep­sy drug, a once-night­ly for­mu­la­tion of sodi­um oxy­bate, which com­pares with the twice night­ly Xyrem.

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