FTC renews Orange Book listing disputes

The Federal Trade Commission announced that it renewed its challenges against “dozens of improperly listed device patents that shield brand-name asthma, diabetes, epinephrine autoinjector, and COPD drugs from prompt generic competition.” The FTC sent warning letters to Novartis (NVS), Amphastar Pharmaceuticals (AMPH), Mylan Specialty (VTRS), Covis Pharma, and three Teva (TEVA) entities, and notified the Food and Drug Administration that it disputes the appropriateness of more than 200 patent listings in the FDA’s Orange Book across 17 different brand-name products. These patent listings, which the FTC has previously disputed, continue to be maintained in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. However, these patents do not meet the statutory criteria for listing in the Orange Book, as confirmed by a recent ruling in the U.S. Court of Appeals for the Federal Circuit, the FTC stated.