Novo Nordisk is suing Hims & Hers over compounded obesity medications

Novo Nordisk announced Monday that it is suing an online telehealth provider Him and him for mass marketing cheaper, unapproved copies of the drugmaker’s new Wegovy 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 the company’s patents and seeking damages.

“This is a complete deception and has been since the end of the shortage,” John Kuckelman, Novos group general counsel for global law, intellectual property and security, said in an interview.

“The fact is that their drugs are untested and they put patients at risk,” he added, pointing out that the safety, effectiveness and quality of compounded drugs are not reviewed by U.S. regulators.

The move escalates the feud between Novo and Hims, which said Saturday that it will stop offering its new copycat obesity pill after coming under scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for just $49 in the first month, about $100 less than Novo’s approved Wegovy pill.

In a statement Monday, Hims said the lawsuit was “a blatant attack by a Danish company on millions of Americans who rely on compounded medications to access personalized care” and another case of Big Pharma “using the U.S. justice system as a weapon to limit consumer choice.”

Hims added that the company has a “long history of providing patients with safe access to personalized healthcare.”

Copenhagen-listed shares of Novo Nordisk rose more than 3% on Monday, while NYSE-listed shares of Hims fell more than 18%.

The lawsuit comes as Novo works to regain market share in the booming obesity drug market and fend off competition from both Eli Lilly and a wave of composite alternatives. These copycats have proliferated because of a loophole in the law that allows companies like Hims to sell compounded versions of patent-protected drugs when brand-name treatments are in short supply.

Semaglutide – the active ingredient in Novo’s pill and its blockbuster injections – is no longer in short supply in the US thanks to the company’s efforts to increase production capacity. No shortages have been reported for the Wegovy pill, which has seen explosive momentum since its launch in the U.S. in early January.

Still, Novo estimated in January that up to 1.5 million Americans use compounded GLP-1 drugs.

Hims has said its compound pill and other GLP-1 products contain semaglutide, even though the ingredient is protected by U.S. patents until 2032. Hims has said its versions are legal because they are “personalized” in dosage.

But Novo said it does not directly or indirectly sell semaglutide to copycats and accused Hims of engaging in illegal mass mixing.

“I would just say that we want an end to mass interest, unlawful mass interest,” Kuckelman said, noting that Novo is not trying to stop all compound interest practices.

He said the composition must be based on legitimate reasons, “as opposed to mass production of what you call a personalized drug, which is really just a variation in dosage.”

Compound medicines may be made on a case-by-case basis when a doctor determines that it is medically necessary for a patient, such as if they cannot swallow a pill or are allergic to a particular ingredient in a brand-name medication.

More CNBC Health coverage

On Friday, the Food and Drug Administration announced that it 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 possible violations.

Kuckelman said some telehealth platforms like Ro are “doing the right thing” by moving to offer patients real, FDA-approved products from Novo and its competitors.

But “some won’t, and hopefully the only way to get Hims and others to put a stop to this is through government enforcement actions and through lawsuits like the one we filed today,” he said.

Novo and Lilly have aggressively targeted pharmacies over the past two years that are profiting from the rising popularity of their weight-loss and diabetes medications. Novo has filed about 130 lawsuits so far alleging deceptive marketing practices and consumer fraud, Kuckelman said.

Lilly has gone through a similar lawsuit involving tirzepatide, the active ingredient in its weight-loss drug Zepbound and the diabetes drug Mounjaro, which is no longer in short supply in the United States