FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers challenging their allegedly improper patent listings in the Food and Drug Administration’s Orange Book. The FTC’s action aims to ensure fair competition and lower healthcare costs by preventing brand-name manufacturers from delaying generic competition. Companies that have received warning letters should review their current listings, especially the underlying claims in the patents, and seek legal counsel to ensure compliance.

Read more here.