The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more
6/3/2025
/ Antitrust Violations ,
Enforcement Actions ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sherman Act ,
Teva Pharmaceuticals ,
Warning Letters
As discussed last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA’s Orange Book for a variety of products was improper. Shortly thereafter, the FTC began...more
FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more