The Federal Trade Commission (FTC) has renewed its challenges against over 200 improper patent listings that it claims are obstructing generic competition for several brand-name drugs. These include medications used for asthma, diabetes, epinephrine autoinjection, and COPD. The FTC argues that these listings prevent generic alternatives from entering the market promptly, keeping drug prices high and limiting patient access to more affordable options.
Warning letters were sent by the FTC to companies such as Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities. Additionally, the FTC notified the Food and Drug Administration (FDA) about its dispute regarding these patent listings in the FDA's Orange Book. The Orange Book is an FDA publication listing "Approved Drug Products with Therapeutic Equivalence Evaluations." According to a recent ruling by the U.S. Court of Appeals for the Federal Circuit, these patents do not meet the statutory criteria for inclusion in this publication.
FTC Chairman Andrew N. Ferguson stated: “The American people voted for transparent, competitive, and fair healthcare markets and President Trump is taking action. The FTC is doing its part.” He emphasized that improper methods limiting market competition harm everyday Americans through higher prices and reduced access.
This initiative follows previous actions taken by the FTC in November 2023 and April 2024 when similar warnings led to delisting patents across 22 different brand-name products. The renewed challenges align with a recent decision by the U.S. Court of Appeals for the Federal Circuit that upheld a District Court's order directing Teva to remove certain asthma inhaler patents from the Orange Book due to improper listing.
Following receipt of disputes from the FTC regarding patent listings still maintained on the Orange Book despite earlier challenges and court rulings, branded drug manufacturers will have 30 days to either withdraw or amend their listings or certify under penalty of perjury that they comply with statutory requirements.
The Federal Trade Commission aims to promote competition while protecting consumers through education initiatives. It emphasizes that it will never request money or make threats during communications with consumers.
