On December 10, 2025, the FTC announced that Teva Pharmaceuticals will “[r]emove. . . Over 200 Improper Patent Listings” to improve generic competition. The Press Release states:
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also withdrawn most of the disputed listings.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.
The Federal Trade Commission works to promote
competition, and to protect and educate consumers. The FTC will never
demand money, make threats, tell you to transfer money, or promise you a prize.
You can learn more about how
competition benefits consumers, file an
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