FTC calls out Jazz Phar­ma's abuse of FDA Or­ange Book list­ing process

The Fed­er­al Trade Com­mis­sion is call­ing to keep strict statu­to­ry lim­its on Or­ange Book patent list­ings, ex­plain­ing in an am­i­cus brief yes­ter­day that patents re­lat­ed to REMS dis­tri­b­u­tion sys­tems should not block gener­ic or oth­er com­pe­ti­tion.

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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