Key Points
- Novo Nordisk is asking a court to permanently block Hims from selling compounded versions of its drugs that allegedly violate patents, and is seeking damages.
- The legal fight intensifies as Hims says it will stop offering its new obesity pill copy after pressure from regulators and legal threats.
- Novo estimated in January that up to 1.5 million Americans may be using compounded GLP-1 weight-loss drugs.
Shares of Novo Nordisk (NVO) jumped more than 5% Monday, while Hims & Hers (HIMS) plunged over 21% in early trading, as a major legal battle shook the booming U.S. weight-loss drug market.
Novo Nordisk announced it is suing telehealth platform Hims & Hers, accusing the company of widely promoting cheaper, unapproved versions of its new Wegovy weight-loss pill and injections across the United States.
The Danish drugmaker is asking the court to permanently stop Hims from selling compounded copies that allegedly infringe on its patents and is also seeking financial damages.
“This is a complete sham, and it has been a sham since the shortage ended,” said John Kuckelman, Novo’s group general counsel for global legal, IP, and security. He warned that compounded medicines are not verified by U.S. regulators for safety, effectiveness, or quality, adding that “untested drugs are putting patients at risk.”
Feud Intensifies as Hims Pulls Back
The lawsuit marks a sharp escalation in the growing clash between the two companies. Just days earlier, Hims said it would stop selling its newly launched copycat obesity pill after facing regulatory scrutiny and legal pressure from Novo.
Hims had planned to price the oral drug as low as $49 for the first month, roughly $100 cheaper than Novo’s FDA-approved Wegovy pill.
Battle for the Booming Weight-Loss Market
The legal move comes as Novo fights to regain market share in the fast-growing obesity drug industry while facing competition from Eli Lilly and a surge of compounded alternatives.
These copycat drugs expanded rapidly under a regulatory loophole that allows companies to sell compounded versions of patented medicines during shortages. But Novo says semaglutide — the key ingredient in Wegovy — is no longer in short supply in the U.S. after the company boosted manufacturing.
The Wegovy pill has seen a powerful launch since hitting the U.S. market in early January, with no current shortages reported. Still, Novo estimates that as many as 1.5 million Americans continue using compounded GLP-1 drugs.
Patent Fight Over Semaglutide
Hims has said its compounded products contain semaglutide, which remains protected by U.S. patents until 2032. The company argues its versions are legal because they are customized for patients with personalized dosing.
Novo strongly disagrees, saying it does not supply semaglutide for copycat use and accusing Hims of illegal mass production.
“We want an end to unlawful mass compounding,” Kuckelman said, noting the company is not trying to eliminate all compounding — only large-scale versions that resemble mass-produced drugs rather than true personalized medicine.
Compounded drugs are typically allowed only when medically necessary for an individual patient, such as when someone cannot swallow pills or is allergic to a specific ingredient in a branded medication.
FDA and DOJ Step In
On Friday, the U.S. Food and Drug Administration said it plans legal action against Hims related to the obesity pill. The agency may restrict access to key ingredients and has referred the company to the Department of Justice over potential violations.
Kuckelman said some telehealth platforms, including Ro, are transitioning patients to real FDA-approved drugs from Novo and its competitors. But he warned that others may only stop through enforcement and lawsuits.
Industry-Wide Crackdown
Novo and Eli Lilly have spent the past two years aggressively targeting compounding pharmacies as demand for weight-loss and diabetes drugs surged.
Novo has already filed around 130 lawsuits tied to deceptive marketing and consumer fraud, according to Kuckelman. Lilly has taken similar action involving tirzepatide, the ingredient in its weight-loss drug Zepbound and diabetes treatment Mounjaro, which is also no longer in shortage in the U.S.
The legal showdown highlights the enormous stakes in the multibillion-dollar weight-loss drug market — and signals that the fight over copycat GLP-1 drugs in America is far from over.
