The agency renewed efforts to remove over 200 disputed patents from FDA’s Orange Book to promote affordable medication access.
The Federal Trade Commission (FTC) recently renewed its challenge of more than 200 device-related drug patents listed in the FDA’s Orange Book, which it claims may be improperly blocking generic versions of asthma, diabetes, epinephrine autoinjector, and COPD medications.
The FTC sent warning letters to several pharmaceutical companies, including Novartis, Teva, Mylan Specialty, Amphastar, and Covis Pharma, arguing the listings do not meet legal standards. These actions follow a ruling from the Federal Circuit’s U.S. Court of Appeals affirming that certain patents listed by Teva were improperly filed.
“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,” said FTC Chairman Andrew Ferguson.
The FTC previously initiated similar challenges in 2023 and 2024, resulting in the delisting of patents from 22 brand-name drugs. Now, the agency is seeking the removal or amendment of disputed listings, which it says keep drug prices high by delaying generics.
As the Lord Leads, Pray with Us…
- For Chairman Ferguson to receive God’s wisdom as he heads the Federal Trade Commission.
- For FTC members and as promote competition in generic medical device offerings.
- For Commissioner Makary to be prudent as he oversees the Food and Drug Administration.
Sources: Federal Trade Commission
