For Release
Teva Removes Over 200 Improper Patent Listings Under Pressure from FTC
FTC investigation prompts Teva request for removal of patents from Orange Book, paving the way for generic competition
After a challenge from the Federal Trade Commission, Teva Pharmaceuticals has requested that the Food and Drug Administration (FDA) remove more than 200 improper patent listings from the FDA’s Orange Book. The FTC sent a series of warning letters in May 2025 to Teva and several other pharmaceutical companies, which have also withdrawn most of the disputed listings.
These challenges are part of the FTC’s broader efforts to promote competition and lower drug prices in keeping with President Trump’s Executive Order on Lowering Drug Prices. Improper patent listings can limit competition by preventing generic alternatives from entering the market. This can keep drug prices artificially high and prevent patients from accessing lower-cost alternatives. The removals of more than 200 improper listings will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors.
“President Trump has promised Americans access to prescription drugs at lower costs. The FTC is fighting to help deliver on that promise,” said FTC Chairman Andrew N. Ferguson. “When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health. The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”
The FTC’s 2025 challenges followed a decision from the U.S. Court of Appeals for the Federal Circuit decision that affirmed that Teva’s patents were improperly listed, consistent with an amicus brief filed by the FTC. The FTC will continue to monitor the pharmaceutical industry for other improper listings and anticompetitive conduct.
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