Delisting of Pharmaceutical Patents Challenged by the Federal Trade Commission

Beginning in 2023, the FTC challenged device-only patents on several drug-device combinations, including inhalers, epinephrine, and GLP-1 products, as being improperly listed in the FDA’s Orange Book. Across the 34 targeted products, companies complied with 90% of delisting requests, shrinking the total listed patents by 80% (from 361 to 72) and reducing the median duration of patent protection from 22.3 to 17.0 years for affected products. By lowering the number of patents generic firms must challenge before approval, these delistings could ease generic entry and improve affordability for several high-cost therapies.