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# FTC Expands ‘Junk’ Patent Challenges
- URL: https://www.fdaweb.com/ftc-expands-junk-patent-challenges/
- Published: 2024-04-30T12:00:00.000Z
- Updated: 2026-09-14T14:29:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156882

The Federal Trade Commission (FTC) has sent warning letters to 10 companies and notified FDA it is challenging more than 300 patents across 20 different brand name products listed by the companies in the FDA *Orange Book*. In a [statement](https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma?ref=fdaweb.com), FTC says it is disputing the patent listings as improper or inaccurate. Improper listings, it says, can delay cheaper generic alternatives from entering the market, keeping branded drug prices artificially high.

The FTC warning letters went to:

- AstraZeneca and Novo Nordisk for obesity and Type 2 diabetes injectable drugs;
- Boehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Novartis, Teva, and some of their subsidiaries for asthma and COPD inhalers; and
- Amphastar Pharmaceuticals for a glucagon nasal spray to treat severe hypoglycemia in Type 1 diabetics.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” says FTC chair **Lina Khan**. “By challenging junk patent filings, FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

When it receives a patent challenge, FDA sends the dispute to the branded drug manufacturer, which has 30 days to withdraw or amend the listing, or certify under penalty of perjury that the listing complies with regulatory requirements.

FTC challenged over 100 patent listings in 11/2023 for medications specific to asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors. The statement says four manufacturers delisted patents in response to those warning letters and later three firms announced commitments to cap inhaler out-of-pocket costs at $35.