Novo Nordisk has sued Hims for allegedly violating patents protecting semaglutide, seeking potentially “hundreds of millions” in damages, John Kuckelman, the pharma’s general counsel, said. The wellness platform pulled its version of the drug just days after launching it.
Novo Nordisk is fililng a lawsuit against Hims & Hers, claiming that the wellness platform has infringed on key patents surrounding semaglutide, the active ingredient of its weight loss drug Wegovy. The complaint not only mentions the oral semaglutide pill that Hims recently said it would manufacture, but also its marketing of compounded injectable formulations of the drug.
“Hims continues to unlawfully mass compound injectable versions, made with inauthentic [active pharmaceutical ingredients], and these knock-offs are putting patient health and wellbeing at risk,” the pharma wrote. In an interview with Endpoints News, John Kuckelman, Novo’s general counsel, said that, depending on how the case plays out, the company could seek trebled damages that could be in “the hundreds of millions” of dollars.
Hims had decided to stop selling its compounded version of a semaglutide pill just days after launching the product, amid the risk of an investigation from the Department of Justice and threats of legal action from Novo Nordisk.
“We’ve had constructive conversations with stakeholders across the industry,” the company said in a short statement posted Feb. 8 on X. “As a result, we have decided to stop offering access to this treatment.” Hims dipped to $19.37 in after-hours trading, nearly 16% lower than its closing price of $23.02 on Friday.
Hims launched its knockoff semaglutide pill last Thursday, giving it an initial promo price of $49 per month before going up to $99 per month. By comparison, Novo Nordisk’s semaglutide pill, sold under the brand name Wegovy, costs $149 at first before jumping to its regular $199 monthly price. It was approved in December 2025 and launched last month
In response to Hims’ offering, FDA Commissioner Marty Makary said that his agency would “take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” The regulator, he continued, “cannot verify the quality, safety, or effectiveness of non-approved drugs.”
Similarly, Mike Stuart, general counsel at the Department of Health and Human Services, said in a Feb. 7 X post that his office has referred the matter “to the Department of Justice for investigation for potential violations” of the Federal Food, Drug, and Cosmetic Act. The DOJ hasn’t yet announced whether it has already started the probe.
Novo had a strong response to Hims’ compounded semaglutide pill from the start. In a statement on Feb. 5, the Danish pharma said that it would “take legal and regulatory action to protect patients, our intellectual property and the integrity of the US gold-standard drug approval framework.”
Novo called Hims’ drug “another example of Hims & Hers’ historic behaviour of duping the American public with knock-off GLP-1 products.” The companies had previously partnered with the goal of making Novo’s semaglutide brands more affordable and accessible to patients.
Just weeks later, however, the relationship broke down over Hims’ continued offering of compounded semaglutide. In a statement alongside the termination of the deal, Novo said Hims engaged in the “deceptive promotion and selling of illegitimate, knockoff versions of Wegovy that put patient safety at risk.”
