WASHINGTON, D.C. — The Federal Trade Commission (FTC) has escalated its efforts to address improper patent listings that hinder generic competition and keep drug prices high. On May 21, the agency issued warning letters to major pharmaceutical companies, including Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities. The FTC also formally notified the Food and Drug Administration (FDA) of concerns about more than 200 patents listed in the Orange Book across 17 branded drug products.
The FTC alleges these patents do not meet the statutory criteria for inclusion in the Orange Book, a publication designed to inform on FDA-approved drugs with therapeutic equivalence. Listings in the Orange Book often serve to block generic alternatives from entering the market, delaying access to cost-effective medications. FTC Chairman Andrew N. Ferguson emphasized the significance of the agency’s actions, stating, “When firms use improper methods to limit competition in the market, it’s everyday Americans who are harmed by higher prices and less access. The FTC will continue to vigorously pursue firms using practices that harm competition.”
This initiative builds on a history of FTC challenges dating back to 2023, which have prompted the removal of patents tied to 22 brand-name drugs. Renewed scrutiny comes after a U.S. Court of Appeals for the Federal Circuit ruling upheld a prior FTC challenge requiring Teva Pharmaceuticals to remove improperly listed asthma inhaler patents. This decision supports the FTC’s longstanding position on Orange Book disputes and provides additional legal momentum in its efforts.
Moving forward, the companies implicated in the latest warnings will have 30 days, upon notification from the FDA, to amend or withdraw disputed listings or certify under penalty of perjury that their entries comply with legal requirements. These actions reflect the FTC’s commitment to ensuring competitive healthcare markets and lowering prescription drug costs for consumers.
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