May 24, 2024


A box of Ozempic made by Novo Nordisk is seen at a pharmacy

The U.S. Food and Drug Administration first approved Ozempic in 2017.
Image: Hollie Adams (Reuters)

The U.S. Federal Trade Commission (FDA) announced on Tuesday that it is disputing over 300 patent listings across 20 different brand name drugs in an effort to promote competition and lower drug prices. Novo Nordisk’s popular diabetes drug Ozempic is among the drugs with patents that are being challenged.

The listings are documented in what is the known as the Food and Drug Administration’s (FDA) Orange Book — a list of FDA-approved drugs. The Orange Book contains patent listings for drug ingredients, manufacturing processes and intellectual property. The FTC argues that improper or inaccurate listings result in artificially high drug prices.

“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,” said FTC Chair Lina M. Khan in a statement. “By challenging junk patent filings, the 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.”

The FTC notified the FDA of the disputes and sent warning letters to 10 pharma companies: AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis Pharmaceuticals Corp., Teva Pharmaceutical Industries Ltd., and Amphastar Pharmaceuticals.

In the letter to Novo Nordisk, the Commission said it was disputing patent listings in regards to the company’s Ozempic, Saxenda, and Victoza brands.

“We received the letter from the FTC and are currently reviewing it,” a Novo Nordisk Spokesperson told Quartz in a emailed statement.

The drug manufacturers now have 30 days to withdraw or amend the disputed listings or prove that they are meet regulatory requirements.

The FTC previously challenged more than 100 patent listings last fall, resulting four companies delisting some patents.

The challenge against Novo Nordisk comes less than a week after the U.S. Sen. Bernie Sanders launched an investigation into the the high prices of Novo Nordisk’s Wegovy and Ozempic in the United States.



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