Novo Nordisk said Monday it was suing the online telehealth provider Him and her for the mass marketing of cheaper, unapproved copies of pharmaceutical manufacturer Wegovy’s new obesity pill and injections in the United States
Novo is asking the court to permanently ban Hims from selling compounded versions of its drugs that infringe on the company’s patents and is seeking relief.
“It’s a complete sham, and it’s been a sham since the shortage ended,” John Kuckelman, Novo Group’s general counsel for global legal, intellectual property and security matters, said in an interview.
“The fact is that their drugs are not tested and they are putting patients at risk,” he added, referring to the fact that the safety, effectiveness and quality of compounded drugs are not verified by US regulators.
The move intensifies the feud between Novo and Hims, which announced Saturday that it would stop offering its new obesity pill after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for just $49 for the first month, about $100 less than the Novo-approved Wegovy pill.
In a statement released Monday, Hims said the lawsuit is “a blatant attack by a Danish company on millions of Americans who rely on compounded medications to access personalized care” and is another case of Big Pharma “weaponizing the American justice system to limit consumer choice.”
Hims added that it has “a long history of providing safe access to personalized health care” to patients.
Copenhagen-listed shares of Novo Nordisk climbed more than 3% on Monday, while NYSE-listed shares of Hims fell more than 18%.
The lawsuit comes as Novo struggles to regain market share in the booming obesity drug market and fend off competition from the two countries. Elie Lilly and a wave of compound alternatives. These imitators have proliferated because of a regulatory loophole that allows companies like Hims to sell compounded versions of patent-protected drugs when brand-name treatments are scarce.
Semaglutide — the active ingredient in Novo’s pill and its blockbuster injections — is no longer in short supply in the United States, thanks to the company’s efforts to increase its manufacturing capacity. No shortages have been reported for the Wegovy pill, which has had an explosive launch since entering the U.S. market in early January.
Despite this, Novo estimated in January that as many as 1.5 million Americans were using medications composed of GLP-1.
Hims said his compound pill and other GLP-1 products contain semaglutide, although the ingredient is protected by U.S. patents until 2032. Hims said his versions are legal because their dosing is “customized.”
But Novo said it did not directly or indirectly sell semaglutide to copycats and accused Hims of engaging in illegal mass preparation.
“I would just say we want to end mass grooming, illegal mass grooming,” Kuckelman said, noting that Novo is not trying to end all mass grooming practices.
He said compounding must be based on legitimate grounds, “instead of producing massive stocks of what you call a personalized medicine, which is really just a variation in dosage.”
Compounded medications may be produced on a case-by-case basis when a doctor determines it is medically necessary for a patient, such as when they cannot swallow a pill or are allergic to a specific ingredient in a brand-name drug.
On Friday, the Food and Drug Administration announced plans to take legal action against Hims over the pill, including restricting access to the ingredients and referring the company to the Justice Department for potential violations.
Kuckelman said some telehealth platforms, such as Ro, are “doing the right things” by providing patients with real FDA-approved products from Novo and its competitors.
But “some won’t, and the only way we can get Hims and others to stop this is, hopefully, through government enforcement action and lawsuits like the one we filed today,” he said.
Novo and Lilly have aggressively cracked down on compounding pharmacies over the past two years as they benefit from the growing popularity of their weight loss and diabetes medications. Novo has so far filed about 130 lawsuits involving deceptive marketing practices and consumer fraud, Kuckelman said.
Lilly followed a similar legal process with tirzepatide, the active ingredient in its weight-loss drug Zepbound, and the diabetes treatment Mounjaro, which is no longer in short supply in the United States.