Hims & Hers Faces New Hurdle In Weight-Loss Brawl With Novo Nordisk

Hims stock landed in hot water this month after Novo Nordisk (NVO) slammed the telehealth giant with a lawsuit over its short-lived attempt to knock off the Danish company’s new weight-loss pill.

Experts say the court case against Hims & Hers Health (HIMS) will have important implications for compounders and branded drugmakers alike.

The move comes as Eli Lilly (LLY) nears potential Food and Drug Administration approval of its new obesity-treating pill, orforglipron, and amid looming competition from big-name companies like Amgen (AMGN), Pfizer (PFE), Roche (RHHBY) and Viking Therapeutics (VKTX).

William Stroever, who co-chairs the intellectual property department at law firm Cole Schotz, said the Novo lawsuit was not surprising. Novo and Hims have spent years feuding over injectable semaglutide. The pill version, launched less than a month after Novo’s hit the market and at a third of the price, was the final straw.

But Stroever doesn’t think this will be the last attempt by compounders to grab some share of the GLP-1 market.

“I think we will definitely see people kind of testing the boundaries,” he told Investor’s Business Daily.

Hims Stock Dives In Messy Battle

The battle between Hims & Hers Health and Novo Nordisk took a messy turn earlier this month. On Feb. 5, the telehealth company launched a compounded version of Novo’s Wegovy pill for just $49 for the first month and $99 each month after.

Hims’ version would have launched a month after Novo’s and for significantly less than the $149 monthly price from Novo Nordisk.

Pressure quickly mounted for Hims & Hers Health. FDA Commissioner Marty Makary said the agency would target “mass-marketing” of “illegal copycat drugs.” A day later, the agency said it would restrict active pharmaceutical ingredients intended for compounded GLP-1 drugs. GLP-1 drugs include weight-loss and type 2 diabetes treatments.

The same day, Mike Stuart, general counsel for Health and Human Services, asked the Department of Justice to investigate whether Hims violated the Federal Food, Drug and Cosmetic Act.

‘Throwing Down The Gauntlet’

Hims & Hers’ launch was really “throwing down the gauntlet,” says Bo Heiden, co-founder and co-director of the Eira Initiative at the Berkeley Policy Institute. The Eira Initiative focuses on innovation policy in life sciences, tackling issues of intellectual property and market exclusivity.

In some ways, it’s not surprising that Hims & Hers pulled its compounded oral semaglutide from the market on Feb. 7, says Cole Schotz’ Stroever. The company cited “constructive conversations with stakeholders across the industry.”

Novo’s lawsuit followed on Feb. 9. The drugmaker says Hims is “deceiving patients and putting their health at risk.” Hims batted back, saying the suit is a “blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care.”

Stroever says Hims probably expected the lawsuit. It’s been a long time coming and Novo could ill afford to show weakness here.

“I think other compounders would have jumped in as well,” he said.

Hims’ Massive Sales Jump

Health and Human Services’ referral to the Department of Justice suggests the agency is taking broad-scale compounding more seriously, says Eira’s Heiden. The FDA “was a bit asleep at the wheel, but now they seem to be awake again,” he said.

At one point, the supply of branded GLP-1 drugs was running short. Under federal regulations, compounders can step in to help offset the supply shortage. But the FDA determined Novo had resolved semaglutide’s shortage in February 2025.

Still, Hims and other compounders have said they fill an important need, making personalized dosages not available from the branded company. That exemption to the supply rule has proved a key loophole, allowing compounders to rake in massive sales.

Hims & Hers Health has yet to report its 2025 sales, but analysts polled by FactSet expect the company to put up $2.35 billion for the year. That would represent 59% year-over-year growth. All but 2% of that is expected to come from online sales. The balance is wholesale revenue.

“You can’t really have a scaled compounding business on other people’s intellectual property,” Heiden said. “There’s nothing wrong with Hims & Hers or any other telehealth organization prescribing the branded product, but to make your own basically is to infringe and to create an illegal copy, except under special circumstances which no longer exist on this scale.”

Can Hims Fight The Lawsuit?

The court’s decision will be key to how other compounders approach the GLP-1 space, says Cole Schotz’ Stroever. Hims & Hers Health has some cash on its balance sheet to fight a legal battle. Analysts expect the company to report $52 million in free cash flow for 2025.

But the same might not be true for smaller compounding outfits. Still, with Lilly and others likely to launch new drugs in the near future, some companies might be able to find a way to sit in this space, Stroever said.

“It might be easier for someone to stay in when they can kind of thread the difference between the two companies,” he said.

There’s also no guarantee a judge would force Hims & Hers Health out of the market. Novo has settled with other compounders — as has Eli Lilly. But the terms of those deals are confidential.

“It’s usually kind of an unhappy compromise,” he said. “It ends up where there’s not a restriction against actually selling the product. It’s going to be more about, ‘Hey, you can’t advertise it this way or that way.’ “

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