Novo Nordisk sues Hims & Hers over cheaper copycat versions of Wegovy pill, injections

Novo Nordisk on Monday said it is suing online telehealth provider Hims & Hers for mass marketing cheaper, unapproved copies of the drugmaker's new Wegovy obesity pill and injections in the U.S. 

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 to recover damages. In a release, Novo accused Hims of "deceiving patients and putting their health at risk," as the safety, efficacy and quality of those copies are not verified by U.S. regulators.

The move escalates the feud between Novo and Hims, which said on Saturday it will stop offering its new obesity pill copycat after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for as little as $49 for the first month, roughly $100 less than Novo's approved Wegovy pill. 

Novo Nordisk's Copenhagen-listed shares were up 7.1% while Hims' NYSE-listed stock was down 19% in premarket as of 7 a.m. ET.

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

Semaglutide — the active ingredient in Novo's pill and its blockbuster injections — is no longer in shortage in the U.S., thanks to the company's efforts to ramp up manufacturing capacity. There are no shortages reported for the Wegovy pill, which has had an explosive launch since it entered the U.S. market in early January. 

Even so, Novo estimated in January that as many as 1.5 million Americans are using compounded GLP-1 drugs.

Hims has said its compounded pill and other GLP-1 products contain semaglutide, despite the ingredient being protected by U.S. patents through 2032. Hims has said that its versions are legal because they are "personalized" in dosage.

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

Hims is "mass marketing unapproved knock-off versions of [Wegovy and Ozempic] that evade the FDA's gold standard review process – that's dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective," said John Kuckelman, Novo's senior vice president of general counsel, global legal, IP and security, in a release. 

On Friday, the Food and Drug Administration announced it planned to take legal action against Hims for the pill, including restricting access to the ingredients and referring the company to the Department of Justice over potential violations.

Novo and Lilly have aggressively cracked down on compounding pharmacies over the last two years as they benefit from the soaring popularity of their weight-loss and diabetes drugs. Lilly has gone through a similar legal process with tirzepatide, the active ingredient in its weight loss drug Zepbound and diabetes treatment Mounjaro, which is no longer in short supply in the U.S.