By Blake Brittain
Feb 10 (Reuters) - Novo Nordisk's U.S. patent lawsuit against Hims & Hers, filed on Monday, marks a new front in the Danish pharmaceutical drugmaker's campaign against companies selling compounded versions of its blockbuster weight-loss drug Wegovy.
The case, Novo's first U.S. patent infringement lawsuit against a compounder over Wegovy, comes as large telehealth companies have expanded rapidly into the weight-loss drug market, and after the U.S. Food and Drug Administration determined
that the drug's active ingredient semaglutide is no longer in short supply.
That shift, experts say, has reduced concerns that enforcing patents could trigger a public backlash by attempting to limit access to a scarce drug.
Novo's lawsuit follows Hims' launch on Thursday of a $49 compounded version of Wegovy, and then a quick retreat, after the FDA announced it would take action against the company on Friday.
In a statement, Hims said the lawsuit "attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer."
Novo's complaint did not specify how much the company was seeking in damages, but Novo's general counsel John Kuckelman told Reuters it was a "very significant amount."
RAPID SCALE-UP
The San Francisco-based telehealth company has grown quickly. It said in November that it expected its total 2025 revenue to be more than $2.3 billion, and has targeted $6.5 billion in revenue by 2030.
"The previous status quo was that pharmaceutical companies were not suing compounding pharmacies for these individualized doses because they were considered to be minor, but the companies have clearly scaled up," said Sarah Rajec, a professor at William & Mary Law School.
U.S. regulations allow compounding pharmacies to make and sell some brand-name medicines if they are in short supply. Without a shortage, however, compounding is generally permitted only when a drug is customized for a particular patient.
The FDA first listed semaglutide as in short supply in 2022, which allowed compounding to proliferate. The agency declared the shortage was over in February 2025, but Hims continued to sell what it calls "personalized" doses of semaglutide, arguing that such sales are lawful when patients require doses Novo does not offer.
LEGAL FIGHT ESCALATES
Novo had previously sued several smaller compounding pharmacies for allegedly selling dangerous or falsely advertised Wegovy "knockoffs" that violate its trademark rights. Those cases focused on the safety of the compounded products and alleged misconduct during a period when the semaglutide shortage heightened sensitivity around access to the drug.
Experts said Novo may have held off on filing patent lawsuits during the shortage in order to avoid negative publicity.
And, patent lawsuits are generally more expensive to litigate and defend than trademark and false-advertising lawsuits and often take years to resolve, but can result in larger damages awards.
"Patents are the big guns," said Robin Feldman, a professor at the University of California Law San Francisco. "After firing a number of shots across the bow, Novo Nordisk has settled in for the major battle."
Hims will likely argue in the case that Novo's patent is invalid. The U.S. Patent and Trademark Office rejected a separate validity challenge to the patent from generic drugmaker Viatris in 2023.
Novo may also seek a preliminary court order blocking Hims from selling compounded Wegovy, though such injunctions are relatively rare in patent cases. The FDA opened a separate potential avenue to block Hims' copies Friday when it said it would restrict GLP-1 ingredients used in compounded drugs, which are not FDA approved.
Novo's general counsel Kuckelman said the Hims case should be "a real wake-up call" to Hims and other companies that are allegedly infringing patents.
"There is now a growing chorus of parties that have said, enough is enough," Kuckelman said. "It was one thing when there was compounding because of a shortage, but what we've entered into now is the wild west of compounding."
(Reporting by Blake Brittain in Washington; additional reporting by Michael Erman in New York; Editing by Alexia Garamfalvi and Sonali Paul)
