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# FTC Takes Issue with Jazz Orange Book Listing
- URL: https://www.fdaweb.com/ftc-takes-issue-with-jazz-orange-book-listing/
- Published: 2022-11-11T12:00:00.000Z
- Updated: 2026-09-14T18:06:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153185

The Federal Trade Commission has filed an [amicus brief](https://www.ftc.gov/system/files/ftc%5Fgov/pdf/P163500JazzPharmaAmicusBrief.pdf?ref=fdaweb.com) with the Delaware federal court in the case of *Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals*, taking issue with a Jazz patent for Xyrem (sodium oxybate) listed in FDA’s *Orange Book* that it says improperly blocks generic competition. The brief discusses the harm to consumers when a brand company improperly lists a patent on a REMS distribution plan for and thereby blocks the introduction of lower-cost generic medications or other follow-on competition.

The FTC brief further addresses how the *Orange Book* listing process can be abused by companies. To the extent the patent only covers Jazz’s REMS system for drug distribution and not a method-of-use patent, it argues that it should be delisted.