Novo sues Hims, alleging patent infringement

Danish pharmaceutical giant Novo Nordisk said Monday it has sued Hims & Hersfor infringing on one of its key patents for semaglutide, the active ingredient in Ozempic and Wegovy.

Shares of Hims extended losses to trade down 20% in the premarket, while Novo rose nearly 6%, though it pared some of its earlier gains.

The move comes after Hims launched — then abruptly discontinued — copies of Novo's Wegovy pill, the first GLP-1 pill approved for weight loss. Hims still sells copies of Novo's injectable GLP-1s.

"Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs," the drugmaker said in a statement.

Hims said in a statement that the 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," the company said. "This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer."

Its short-lived launch of an oral semaglutide product appeared to be a tipping point for Novo and regulators, which until now had not taken aggressive action against Hims despite critiquing its behavior.

The patent Novo is accusing Hims of violating encompasses both oral and injectable semaglutide, meaning the suit not only threatens Hims’ newly launched and discontinued pill, but also the injectable versions it has been selling for much longer.

Hims' legal woes mount

Hims launched its copy of Novo's Wegovy pill Thursday morning. Hours later, Novo released a statement threatening “legal and regulatory action” against Hims. That evening, FDA Commissioner Marty Makary said in an X post that the agency would “take swift action against companies mass-marketing illegal copycat drugs.”

Mike Stuart, the top lawyer at the Department of Health and Human Services, the FDA's parent agency, said in a post on X on Friday he has referred Hims to the Department of Justice "for investigation for potential violations by Hims of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions."

It is unclear when or if the DOJ may take action against Hims. The FDCA carries both civil and criminal implications. Less than a day after Stuart's post, Hims said it would discontinue the pill.

Novo's lawsuit, meanwhile, is the latest salvo in a nearly year-long battle between the two companies.

Hims and other telehealth companies began selling cheaper copies of Novo’s injectable weight-loss drug in 2024 while they were allowed to because the drug was in a shortage. Even after the shortage ended, Hims continued to sell copies it says are “personalized” for patients.

Novo has expressed frustration that regulators had not cracked down on this legal loophole. Novo lowered its cash-pay prices and forged partnerships with other telehealth companies, including at one point Hims. That partnership was short-lived and ended epically in June after Hims did not stop selling copies of Novo's drugs.

Novo has sued smaller players, mostly alleging false advertising, not patent infringement. Those lawsuits have been largely unsuccessful.

Hims CEO Andrew Dudum has consistently said that the company wouldn't back down from pressure from Big Pharma. In a statement after Novo's threats but before the FDA's, Hims dismissed the drugmaker's attacks as "outdated."

"This is not the first time (nor will it be the last time) a big pharma company has suggested taking an accessible, customer-first approach to healthcare is dangerous, illegal, or bad for the marketplace," the company said in a statement. "This narrative is as predictable as it is outdated and false.