On Tuesday, the Federal Trade Commission (FTC) said it is challenging hundreds of what it calls "junk" patents associated with 20 brand-name drugs, including Novo Nordisk’s top-selling medications Ozempic, Saxenda, and Victoza.
The regulator argues that these patents are incorrectly or inappropriately listed, marking a significant move in its broader campaign to modify or remove entries from the Orange Book that it believes are improper and obstruct the entry of generic drugs. Orange Book refers to a document where the Food and Drug Administration (FDA) manages its patent listings for approved drugs.
“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,” FTC Chair Lina Khan said in a release.
“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.”
Commenting on this FTC move, analysts at TD Cowen, said:
“We continue to assume loss of exclusivity for semaglutidebased products in the US will occur when the drug substance patent expires in Dec. 2031, consistent with Novo's commentary.”
“Given that the FTC is not disputing this patent - which represents the most reliable form of protection for Ozempic, Wegovy, and Rybelsus - it does not appear to be at risk from this action.”
Moreover, patent 10,335,462, which is a method of use patent that could protect Ozempic until 2033, is also not being targeted by the FTC.