Novartis, Teva, others receive warning letters from US FTC over Orange Book patents
( May 21, 2025, 17:08 GMT | Official Statement) -- MLex Summary: The US Federal Trade Commission sent warning letters to Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma and three Teva entities, stating that it disputes the appropriateness of more than 200 patent listings in the US Food and Drug Administration's Orange Book across 17 different brand-name products. The FTC previously disputed the patent listings, which continue to be maintained in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. The patents do not meet the statutory criteria for listing in the Orange Book, as confirmed by a recent ruling in the US Court of Appeals for the Federal Circuit, the FTC said. "Continuing its efforts to promote competition and lower drug prices, today the Federal Trade Commission 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. Improper patent listings can delay generic alternatives from entering the market, keeping drug prices artificially high and preventing patients from accessing lower cost drugs," the agency said.Statement follows....
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