On Monday, the Danish drugmaker said it is suing Hims & Hers, accusing the online telehealth company of mass marketing cheaper, unapproved copies of its popular Wegovy obesity drug in the United States. According to Novo, these copycat pills and injections violate its patents and put patients at risk.

Novo wants the court to permanently stop Hims from selling compounded versions of its drugs and is also seeking financial damages.

“This is a complete sham,” said John Kuckelman, Novo’s group general counsel for global legal, intellectual property, and security. “And it’s been a sham since the shortage ended.”

Here’s the thing. Compounded drugs aren’t reviewed by U.S. regulators in the same way FDA-approved medicines are. Their safety, quality, and effectiveness aren’t verified. That’s Novo’s core argument. Kuckelman says Hims is selling untested medicines at scale and calling them personalized care when, in reality, they’re just dosage tweaks.

Hims sees it very differently.

In a statement released Monday, the company called the lawsuit “a blatant attack” by a foreign pharmaceutical giant on Americans who rely on compounded drugs for access and affordability. Hims also accused Big Pharma of using the U.S. legal system to limit consumer choice. Strong words.

The legal move ramps up a growing feud between the two companies. Just days earlier, Hims said it would stop offering its new copycat obesity pill after facing pressure from federal regulators and legal threats from Novo. The pill had been pitched at a tempting price point, as low as $49 for the first month. That’s about $100 cheaper than Novo’s FDA-approved Wegovy pill.

Markets reacted fast. Novo Nordisk’s shares, listed in Copenhagen, jumped more than 3 percent on Monday. Hims’ stock, traded in New York, dropped over 18 percent.

This lawsuit comes at a crucial time. Novo is trying to defend its position in the booming obesity drug market while fighting off competition from Eli Lilly and a wave of compounded alternatives. Those alternatives flourished during supply shortages, thanks to a regulatory loophole that allows compounded versions of patented drugs when approved options aren’t available.

But that shortage is over.

Semaglutide, the active ingredient in Wegovy and Novo’s blockbuster injections, is no longer in short supply in the U.S. Novo says it has ramped up manufacturing, and there are currently no shortages of its obesity pill, which launched in January and took off quickly.

Even so, Novo estimates that about 1.5 million Americans are still using compounded GLP-1 drugs.

Hims has openly said its compounded products contain semaglutide, despite the ingredient being protected by U.S. patents through 2032. The company argues its versions are legal because they are personalized. Novo strongly disagrees, saying it does not sell semaglutide to copycats in any form and accusing Hims of illegal mass compounding.

“Compounding has to be based on legitimate medical needs,” Kuckelman said. “Not stockpiling drugs and calling them personalized just because the dose is slightly different.”

To be clear, compounding itself is legal in certain cases. Doctors can request compounded drugs for individual patients who can’t tolerate approved medicines, can’t swallow pills, or are allergic to certain ingredients. The issue, Novo says, is scale.

Regulators are paying attention. On Friday, the Food and Drug Administration said it plans to take legal action against Hims over the pill. That could include restricting access to key ingredients and referring the company to the Department of Justice.

Some telehealth companies, Kuckelman noted, are already backing away from compounded products. Platforms like Ro are transitioning patients to FDA-approved treatments from Novo and its competitors. Others, he said, are not.

“And at this point,” he added, “lawsuits and government enforcement may be the only way to stop it.”

Novo and Lilly have been on a legal offensive for the past two years as demand for weight-loss and diabetes drugs has exploded. Novo alone has filed around 130 lawsuits related to deceptive marketing and consumer fraud. Lilly has followed a similar path with tirzepatide, the ingredient behind Zepbound and Mounjaro, now also out of shortage in the U.S.

Bottom line? The fight over obesity drugs isn’t just about science anymore. It’s about access, pricing, patents, and where regulators draw the line. And for companies like Novo and Hims, this battle is far from over.