The brand of pharmaceutical firm Novo Nordisk is displayed in entrance of its workplaces in Bagsvaerd, Copenhagen, Denmark, February 4, 2026.
Tom Little | Reuters
Novo Nordisk on Monday stated it’s suing on-line telehealth supplier Hims & Hers for mass advertising and marketing cheaper, unapproved copies of the drugmaker’s new Wegovy weight problems tablet and injections within the U.S.
Novo is asking the courtroom to completely ban Hims from promoting compounded variations of its medicine that infringe on the corporate’s patents and is in search of to get better damages.
“This can be a full sham, and it has been a sham because the scarcity ended,” stated John Kuckelman, Novo’s group common counsel of worldwide authorized, mental property and safety, in an interview.
“The very fact is that their medicines are untested, they usually’re placing sufferers in danger,” he added, referring to how the protection, efficacy and high quality of compounded medicines usually are not verified by U.S. regulators.
The transfer escalates the feud between Novo and Hims, which stated on Saturday it’ll cease providing its new copycat weight problems tablet after going through scrutiny from federal regulators and authorized threats from the Danish drugmaker. Hims had deliberate to supply the oral drug for as little as $49 for the primary month, roughly $100 lower than Novo’s authorised Wegovy tablet.
Novo Nordisk’s Copenhagen-listed shares had been up greater than 5% whereas Hims’ NYSE-listed inventory was down 21% in premarket as of 8 a.m. ET.
The lawsuit comes as Novo works to reclaim market share within the booming weight problems drug market and fend off competitors from each Eli Lilly and a wave of compounded alternate options. These copycats have proliferated underneath a regulatory loophole that enables corporations like Hims to promote compounded variations of patent-protected medicine when branded remedies are briefly provide.
Semaglutide — the energetic ingredient in Novo’s tablet and its blockbuster injections — is now not in scarcity within the U.S., due to the corporate’s efforts to ramp up manufacturing capability. There aren’t any shortages reported for the Wegovy tablet, which has had an explosive launch because it entered the U.S. market in early January.
Even so, Novo estimated in January that as many as 1.5 million People are utilizing compounded GLP-1 medicine.
Hims has stated its compounded tablet and different GLP-1 merchandise include semaglutide, regardless of the ingredient being protected by U.S. patents by way of 2032. Hims has stated that its variations are authorized as a result of they’re “personalised” in dosage.
However Novo stated it doesn’t straight or not directly promote semaglutide for copycats, and accused Hims of partaking in unlawful mass compounding.
“I might simply say we do need an finish to to mass compounding, to illegal mass compounding,” Kuckelman stated, noting that Novo will not be making an attempt to finish all compounding practices.
He stated compounding must be primarily based on reputable grounds, “versus you producing mass shares of what you are calling a customized medication, which is basically only a dosage variation.”
Compounded medicine may be produced on a case-by-case foundation when a health care provider determines it’s medically essential for a affected person, equivalent to after they cannot swallow a tablet or are allergic to a particular ingredient in a branded drug.
On Friday, the Meals and Drug Administration introduced it deliberate to take authorized motion in opposition to Hims for the tablet, together with limiting entry to the elements and referring the corporate to the Division of Justice over potential violations.
Kuckelman stated some telehealth platforms, equivalent to Ro, “are doing the fitting issues” by transitioning to offering sufferers with actual FDA-approved merchandise from Novo and its opponents.
However “some will not, and the one means it seems that we’ll get Hims and others to cease that is by way of hopefully authorities enforcement actions and thru lawsuits just like the one which we have filed at present,” he stated.
Novo and Lilly have aggressively cracked down on compounding pharmacies over the previous two years as they profit from the hovering recognition of their weight-loss and diabetes medicine. Novo has to this point filed round 130 lawsuits coping with misleading advertising and marketing practices and shopper fraud, Kuckelman stated.
Lilly has gone by way of a related authorized course of with tirzepatide, the energetic ingredient in its weight reduction drug Zepbound and diabetes remedy Mounjaro, which is now not briefly provide within the U.S.
