FTC targets 200+ Orange Book patents to boost generic drug access

The Federal Trade Commission has escalated its efforts to increase competition and lower drug prices by renewing challenges to more than 200 patent listings in the U.S. FDA Orange Book. These patents, linked to 17 brand-name drugs -- including treatments for asthma, diabetes, epinephrine autoinjectors and chronic obstructive pulmonary disease -- are alleged to significantly delay the entry of generic competitors. 

On May 21, 2025, the Federal Trade Commission (FTC) sent warning letters to several pharmaceutical manufacturers, including Novartis Pharmaceuticals Corp., Amphastar Pharmaceuticals Inc., Mylan Specialty LP, Covis Pharma GMBH, Norton (Waterford) Limited and three Teva entities: Teva Branded Pharmaceutical Products R&D, Inc., Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc.  

This marks the third round of FTC challenges aimed at curbing what it identifies as anti-competitive practices that can delay generics and inflate drug prices. 

The FTC's action follows a December 2024 ruling by the U.S. Court of Appeals for the Federal Circuit. That decision upheld a lower court's order for a company to delist five Orange Book patents related to inhaler devices, which were found not to meet statutory requirements because they did not claim the drug itself or its method of use. 

Reinforcing its legal foundation, the FTC issued a policy statement in September 2023, warning that improper Orange Book patent listings could comprise unfair methods of competition under Section 5 of the FTC Act. The agency emphasized that such listings can harm competition and hinder timely generic drug entry, ultimately raising prices for consumers. 

Industry implications 

Experts predict that the FTC's action will have an impact on industry competition.

"When firms use improper methods to limit competition in the market, it's everyday Americans who are harmed by higher prices and less access," FTC Chairman Andrew N. Ferguson said in the agency's press release. "The FTC will continue to vigorously pursue firms using practices that harm competition." 

Companies that received the FTC's warning letters now face a 30-day deadline to withdraw or amend the contested listings or certify, under penalty of perjury, that the patents comply with all applicable legal and regulatory requirements. The FTC has not yet indicated whether it will initiate further legal action against firms that fail to comply. 

As regulatory scrutiny ramps up, drugmakers are urged to conduct thorough reviews of their Orange Book listings to ensure compliance. Improper entries could invite regulatory challenges, legal consequences and competitive disadvantages. 

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.