The Federal Trade Commission (FTC) holds the position that competition in the drug market is beneficial and leads to lower medication prices. Reflecting this view, the FTC has taken proactive steps in 2023 and 2024 to address what it considers improper patent listings in the Food and Drug Administration’s (FDA’s) “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the Orange Book.

These improper patents largely involve drug-delivery devices, such as asthma and COPD inhalers, injectable devices for obesity and type 2 diabetes, epinephrine autoinjectors, and others. The patents associated with many of these drug-delivery devices often prohibit the FDA from approving generic products with certain delivery devices, leading to higher drug costs for patients and the healthcare system. Essentially, the FDA cannot approve certain generics because of limitations surrounding the delivery device and not the drug itself.  Previous actions taken by the FTC resulted in the delisting of patents across 22 different brand name products. For more details on the topic, be sure to check out our previous blog post on the FTC’s actions against patents in 2023 and 2024.

Recently, the U.S. Court of Appeals for the Federal Circuit ordered Teva to delist several asthma inhaler patents from the FDA’s Orange Book. The FTC previously flagged these patents through the FDA’s Orange Book dispute process, and the court’s decision reinforced the importance of accuracy in the listing process. Building on this development, the FTC sent out a new round of warning letters on May 21, 2025, notifying both the FDA and several manufacturers. The manufacturers include Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities. The legitimacy of over 200 patent listings across 17 different brand name products has been called into question by the FTC. Under the FDA procedures, once the FDA forwards the patent listing disputes, each respective manufacturer will have 30 days to respond to the disputes and determine whether to maintain or voluntarily withdraw the challenged listings.

While regulatory change can take time, the FTC has reiterated its commitment to maintaining oversight in the drug pricing market. The FTC continues to speak out about the potential harm associated with improper listings and their impact on market competition and drug affordability. FTC Chairman Andrew N. Feguson emphasized the Commission’s role, 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.” As the process unfolds, attention will turn to how manufacturers respond to this latest round of patent listing inquiries and what further impact this may have on competition in the pharmaceutical marketplace.