Hims built a boundary-pushing health business. Now the legal risks are catching up.

Hims & Hers aired its second Super Bowl commercial on Sunday, questioning a healthcare system it describes as built for the wealthy and again painting itself as a disrupter of the status quo.  

A day earlier, the telehealth giant bowed to pressure from the Food and Drug Administration and said it would stop selling a product it had launched just two days earlier: a copy of Novo Nordisk’s new weight-loss pill. The next day, Hims was hit with a lawsuit by the Danish pharmaceutical giant alleging patent infringement.  

Hims has a reputation in the industry for making bold moves, which until recently it has done largely without consequences. But as its legal troubles mount, the company’s stock has taken a hit. Hims is now trading at roughly the same level as when it first began selling copies of Novo’s GLP-1 drugs in May 2024.

GLP-1 drugs have been a major source of growth for Hims. The company disclosed that it generated about $420 million in GLP-1 revenue in the first half of 2025, nearly double the roughly $225 million it reported for all of 2024.

“My perception is that Hims & Hers has tried to push the line progressively and probably didn’t think this was stepping across it,” former FDA chief Scott Gottlieb told CNBC on Monday morning.

Opponent #1: The government 

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 that he 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.”

A DOJ investigation opens the door to civil or criminal enforcement that goes beyond the FDA’s usual administrative tools, such as warning letters or recalls, said Darshan Kulkarni, a regulatory and compliance attorney who represents FDA-regulated companies.

Title 18 includes federal criminal laws covering conduct like fraud or conspiracy. In some cases, prosecutors can also seek to hold company executives personally liable for FDA violations.

“I think that changes the stakes at that point,” Kulkarni said. “You’re not dealing with an administrative agency anymore.”

Novo’s Wegovy pill contains the same active ingredient (semaglutide) as its Wegovy injection, which was approved in 2021. But the pill relies on patented technology, known as SNAC, to protect the compound as it passes through the digestive tract before being absorbed into the bloodstream.

Unlike copies of injectable GLP-1s, it’s possible the pill marketed by Hims would not work at all. Hims — or rather its partner pharmacy, Strive — said it could replicate SNAC by using “liposomal technology.” There are no publicly available human trials showing that works on semaglutide. 

“If that’s true, then this is an unapproved new drug, because it’s using a new technology to try to get the oral absorption,” Gottlieb said on CNBC.

Gottlieb noted that the FDA typically takes administrative steps before escalating to the DOJ, suggesting the agency may be eager to go to court and secure a ruling against Hims.

Opponent #2: The drugmaker

Novo sued Hims on Monday, accusing it of infringing on one of its key patents for semaglutide, the active ingredient in Ozempic and Wegovy.

John Kuckelman, head of intellectual property at Novo, told Stat on Monday that Hims has been infringing on its IP since the shortage ended, but said its launch of a pill “was a tipping point.” He said the “safety issues at stake” led the company to take action.

Novo has previously sued smaller players, mostly alleging false advertising rather than patent infringement. Those lawsuits have been largely unsuccessful.

It has been long speculated that Novo may bring a suit defending its IP. (A now closed Kalshi prediction market pegged the odds as high as 69% in August.) The suit carries some risk: if the drugmaker were to lose, it could invalidate the patent on its most lucrative drugs. 

Kuckelman said the company has “full confidence in the validity of our compound patent.” He said “at minimum,” the drugmaker wants reasonable royalties, but it also intends to recover lost profits.

“Anybody who is infringing our patents should be very, very much on notice that we take that seriously, and that we will enforce our patents,” he said. “If anybody out there thinks we will not, this should be a wake-up call to them.”