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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER