The ongoing feud between Novo Nordisk, makers of Ozempic and Wegovy, and Hims & Hers Health Inc. has reached a breaking point.
On Monday, the pharmaceutical company announced it was filing a lawsuit against Hims over its continued distribution of compounded GLP-1 products that mimic its blockbuster weight loss drugs. The legal action is the latest in a fast-developing saga that saw Hims pull its copycat Wegovy pill just days after announcing it last week, though only after the Food and Drug Administration stepped in to reprimand the telehealth company.
“Hims & Hers 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 F. Kuckelman, senior vice president and general counsel at Novo, in a statement from the drugmaker.
The GLP-1 war
Semaglutide is the active ingredient in Ozempic and Wegovy. It’s a synthetic form of GLP-1, a hormone that regulates our appetite and hunger. The trouble between Hims and Novo Nordisk over its semaglutide-based drugs first began last year.
In June, Novo abruptly dissolved its partnership with Hims to distribute discounted Wegovy, two months after it had first announced the deal. The pharmaceutical accused Hims of using “deceptive marketing” to continue widely selling compounded semaglutide to its customers.
Compounded drugs are custom-made formulations of existing medications that can be produced and distributed under certain circumstances. Soon after Wegovy’s approval in 2021, many telehealth companies partnered with compounding pharmacies to sell cheaper, compounded GLP-1 drugs, often with the justification of the standard drugs being in shortage. These shortages have since abated, though, and the FDA has tried to crack down on the practice in recent years. Novo Nordisk and Eli Lilly, makers of the other popular GLP-1 drug, tirzepatide, have also sued specific pharmacies and distributors.
Many of these lawsuits are still being hashed out in court, and the marketplace of compounded GLP-1s still appears to be robust, if in murky legal territory. Last week, however, Hims took its boldest step yet in the war between the two companies.
The Wegovy copycat
Late last year, Novo Nordisk received approval for a new pill version of its obesity drug Wegovy. The drug has sold well so far, aided by list prices that have continued to drop recently (Wegovy was originally over $1,000 a month without insurance, while the pill sells for as little as $150 a month). Last Thursday, Hims announced it would be selling its own compounded version of the semaglutide pill for even cheaper (starting at $49 a month). The move quickly angered Novo Nordisk but also alarmed some health experts.
Compounded drugs generally aren’t vetted for safety and effectiveness as rigorously as standard drugs. Semaglutide and other GLP-1s also aren’t easily absorbed through the digestive tract, which has limited them from being taken as a pill. Novo Nordisk devised a proprietary method of making their drug to get around this limitation (known as SNAC). Hims claimed its pill was not using SNAC technology, but this raised the question of whether the drug could actually be absorbed enough to work as advertised.
Either way, the federal government wasn’t a fan of Hims’ new product. Within a day, the FDA issued a statement that it would go after any company attempting to skate FDA regulations by making and distributing compounded GLP-1 copycats. Though Hims initially defended its actions, the company soon relented. By Saturday, Hims announced it would withdraw the GLP-1 pill, following “constructive conversations with stakeholders across the industry.”
A legal battle
Him’s about-face hasn’t stopped Novo Nordisk from going full tilt after the company, however. In its lengthy lawsuit, filed today in the district court of Delaware, Novo claims Hims’ marketing and distribution of its compounded semaglutide products has violated the patent covering Novo’s brand-name drugs. Stat News has uploaded the lawsuit for public view.
For now, at least, Hims isn’t fully backing down. In a statement released this morning, the company called the lawsuit “a blatant attack” by the Danish-based pharmaceutical on the millions of Americans who rely on compounded drugs for personalized care.
Novo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice. This lawsuit attacks more than just…
— Hims & Hers Comms (@HimsHersComms) February 9, 2026
The legal fate of compounded GLP-1 drugs may take years to fully shake out. But it’s certainly possible Hims could be in hotter water than other telehealth companies given its brazenness over the last week.
English (US) ·