FTC Renews Push to Remove Improper Drug Patents That Block Generics

The agency is challenging more than 200 patent listings it says were improperly used to keep prescription prices high.

Medications at a pharmacy in Los Angeles on May 12, 2025. Eric Thayer/Getty Images

The Federal Trade Commission on May 21 escalated its efforts to lower prescription drug costs, renewing challenges to more than 200 patents it says were improperly listed to prevent generic versions of brand-name drugs from reaching the market.

The FTC sent warning letters to seven pharmaceutical companies: Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities.

The agency accused them of using invalid or misclassified patents to delay generic competition for 17 drugs, including asthma inhalers, diabetes treatments, and epinephrine autoinjectors (EpiPen). These patents are listed in the FDA’s Orange Book, a database that helps determine which products are eligible for generic approval and exclusivity protections.

“Improper patent listings can delay generic alternatives from entering the market, keeping drug prices artificially high and preventing patients from accessing lower cost drugs,” the FTC said in a May 21 statement.

The latest round of challenges follows FTC actions in November 2023 and April 2024 that led to the delisting of patents on 22 drugs, the agency said. In December 2024, a federal appeals court ruling upheld a lower court decision ordering Teva to remove improperly listed inhaler patents, siding with the FTC in that case.

FTC Chairman Andrew Ferguson said the enforcement is part of a broader push by the Trump administration to reduce prescription drug costs.

“The American people voted for transparent, competitive, and fair healthcare markets, and President Trump is taking action. The FTC is doing its part,” Ferguson said.

“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.”

Under the process, the FDA will notify drugmakers of the FTC’s disputes. Each company has 30 days to either withdraw the patent listing or certify under penalty of perjury that the listing complies with statutory requirements.

The action builds on other recent federal efforts to curb drug prices. On May 20, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services announced benchmark pricing targets for brand-name drugs under a revived “Most-Favored-Nation” (MFN) pricing model.

Based on a May 12 executive order from President Donald Trump, the policy aims to align U.S. drug prices with the lowest prices paid in peer nations such as Germany and Japan.

Health officials said the MFN model would apply to high-cost drugs without generic alternatives and warned that failure by manufacturers to lower prices voluntarily could trigger further regulatory action.

A similar Trump-era initiative in 2020 was projected to save $88 billion but was blocked in court before it could take effect.

Both the FTC and HHS actions are facing resistance from pharmaceutical companies, which argue that the measures could limit innovation and reduce access to new treatments.

The companies that received letters this week from the FTC did not respond to requests for comment from The Epoch Times before publication time.