Novo Nordisk just made it very clear: the era of cheap semaglutide knockoffs is over, and it’s willing to sue its way to that outcome.
The Danish pharmaceutical giant filed a lawsuit Monday against telehealth darling Hims & Hers Health, alleging the company infringed on U.S. Patent 8,129,343 by mass-marketing compounded versions of semaglutide, the blockbuster active ingredient in Wegovy and Ozempic. Novo is asking the court to permanently ban Hims from selling these copycat drugs and is seeking damages that its general counsel says could reach “hundreds of millions” of dollars.
The market reaction was swift and brutal. HIMS shares cratered more than 27% on Monday, extending a punishing weeklong selloff that has wiped out roughly half the stock’s value from its 52-week highs. Novo Nordisk’s Copenhagen-listed shares, meanwhile, climbed more than 3%. Eli Lilly, which stands to benefit from any crackdown on compounders eating into branded GLP-1 sales, rose about 2%.
This isn’t a polite corporate disagreement. It’s a full-scale legal assault, and it comes with the FDA and Department of Justice already circling Hims like sharks that smell blood.
The Timeline That Got Us Here
The saga unfolded at breakneck speed. On Thursday, Hims announced it would begin offering a compounded semaglutide pill through its telehealth platform, priced at $49 for the first month and $99 thereafter. That’s roughly $100 cheaper than Novo’s FDA-approved Wegovy pill, which launched in January at $149 introductory before rising to $199 monthly.
Novo Nordisk responded within hours, calling it “an unapproved, inauthentic, and untested knockoff” and promising legal action. FDA Commissioner Marty Makary didn’t mince words either, pledging “swift action against companies mass-marketing illegal copycat drugs.”
By Friday, the situation escalated dramatically. The FDA announced plans to take legal action against Hims, including restricting access to the GLP-1 ingredients compounding pharmacies use to make their knockoff products. The Health and Human Services Department referred Hims to the Department of Justice for investigation into potential violations of the Federal Food, Drug, and Cosmetic Act.
Saturday, Hims blinked. The company announced it would pull its copycat pill from the market, posting on social media that it had “constructive conversations with stakeholders across the industry.” That’s corporate speak for “the FDA and DOJ made it clear we were in serious trouble.”
Then came Monday’s lawsuit, because Novo clearly decided that pulling the pill wasn’t enough.
What Novo Nordisk Actually Alleges
The lawsuit targets more than just the now-discontinued compounded pill. Novo’s complaint also takes aim at Hims’ ongoing sale of compounded injectable versions of semaglutide, which the company continues to market as alternatives to Wegovy and Ozempic injections.
“This is a complete sham, and it has been a sham since the shortage ended,” said John Kuckelman, Novo’s group general counsel, in an interview. “The fact is that their medicines are untested, and they’re putting patients at risk.”
That “shortage” reference is key. The FDA allows compounding pharmacies to produce brand-name medicines when there’s a legitimate supply shortage. For months during 2023 and 2024, semaglutide was in shortage as demand for GLP-1 weight loss drugs exploded. That shortage created a regulatory loophole that companies like Hims exploited aggressively, building massive compounded semaglutide businesses.
But semaglutide is no longer in shortage. Novo ramped up manufacturing capacity, and the FDA has confirmed supply is adequate. Without a shortage, compounding is only permitted when a drug is genuinely personalized for individual patients, not mass-marketed through a telehealth platform to anyone with a credit card.
Novo estimates that roughly 1.5 million Americans are currently using compounded GLP-1 drugs. That’s 1.5 million potential customers buying knockoffs instead of Wegovy or Ozempic, and Novo wants them back.
The Patent Problem Hims Can’t Wish Away
Hims has argued its compounded products are legal because they’re “personalized” in dosage. Novo’s lawyers aren’t buying it.
Semaglutide is protected by U.S. patents through 2032. Hims has openly stated its compounded products contain semaglutide as the active ingredient. Novo says it doesn’t sell semaglutide to compounders directly or indirectly, which raises uncomfortable questions about where Hims’ compounding pharmacies are sourcing what Novo calls “inauthentic” active pharmaceutical ingredients.
The safety angle is real, not just legal posturing. Compounded drugs bypass the FDA’s rigorous approval process. They may contain impurities, incorrect dosages, or unnecessary ingredients. The FDA has previously issued warnings about adverse events linked to compounded semaglutide products. When you’re injecting something into your body or swallowing a pill, “close enough” isn’t the same as “FDA-approved.”
Hims’ Defense: Populism Meets Legal Reality
Hims fired back with the kind of rhetoric designed to win public sympathy, if not court cases. The company called the lawsuit “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care” and accused Big Pharma of “weaponizing the US judicial system to limit consumer choice.”
It’s effective messaging. Americans paying $199 a month for a Wegovy pill when a compounded version costs $49 will naturally sympathize with the cheaper option. The “David vs. Goliath” framing is deliberate and, frankly, smart PR.
But populism doesn’t override patent law. And Hims’ legal position looks increasingly precarious. The company already pulled its pill. The FDA is restricting ingredient access. The DOJ is investigating. And now Novo is suing for potentially hundreds of millions in damages. That’s a lot of incoming fire for a company whose stock just hit a 52-week low.
The Broader GLP-1 Crackdown
This lawsuit isn’t just about Hims. It’s a warning shot to the entire compounded GLP-1 industry.
Kuckelman made that explicit: telehealth companies and compounding pharmacies that continue selling copycat semaglutide “should be very, very much on notice.” He noted that some competitors, like telehealth platform Ro, are already transitioning patients to FDA-approved products. “Some won’t,” he said, “and the only way it appears that we’re going to get Hims and others to stop this is through hopefully government enforcement actions and through lawsuits.”
Analysts see the FDA’s aggressive response as potentially the beginning of a broader crackdown. Sydbank analyst Soren Lontoft Hansen said Novo and the FDA are “not only declaring war on Hims & Hers’ Wegovy pill, but GLP-1 compounders in general.” If the FDA restricts access to the raw semaglutide ingredients that compounders use, the entire copycat market could collapse.
That would be a massive win for both Novo Nordisk and Eli Lilly, whose branded GLP-1 drugs have seen sales eroded by cheaper compounded alternatives. Lilly’s oral GLP-1 pill, orforglipron, is expected to launch in April, adding another FDA-approved option that competes directly with compounders on convenience.
What It Means For HIMS Investors
The numbers tell a grim story. HIMS stock is down more than 40% from its 52-week highs, and the worst may not be over. The company reports Q4 and full-year 2025 earnings on February 23, and investors will be listening for any signal about how Hims plans to replace the GLP-1 revenue stream that’s being systematically dismantled.
Hims built a significant portion of its recent growth story on compounded semaglutide. Revenue hit approximately $2 billion last year, and the company achieved profitability. But strip out the GLP-1 tailwind, and you’re left with a telehealth platform that sells hair loss and erectile dysfunction treatments. A fine business, but not the high-growth story that justified the stock’s former premium.
The company is pivoting, as companies in trouble always do. It recently launched a multi-cancer screening blood test and is expanding into testosterone therapy and at-home diagnostics. These are real businesses with real potential. But they take time to scale, and Hims may not have the luxury of patience with its stock in freefall and federal investigators asking questions.
Short interest on HIMS sits at roughly 30%, suggesting plenty of investors are betting the pain isn’t over.
The Bigger Picture
There’s an uncomfortable tension at the heart of this fight. Novo Nordisk’s semaglutide patents are valid and enforceable. Patient safety concerns about unregulated compounded drugs are legitimate. The FDA’s authority to regulate what Americans put in their bodies matters.
But it’s also true that Novo Nordisk’s market value dropped nearly two-thirds from its 2024 peak, partly because of competition from compounders. The company flagged “unprecedented price pressure” just last week. This lawsuit isn’t purely about patient safety. It’s about protecting a revenue stream worth tens of billions of dollars annually.
And the access question is real. At $199 per month, Wegovy pills are cheaper than Wegovy injections, but they’re still out of reach for millions of Americans without insurance coverage. Compounded versions filled a gap that branded drugs left open. Shutting down compounders without addressing affordability just means fewer people get treatment.
Novo and Lilly have both been cutting prices and expanding access through programs like Costco partnerships and direct-to-consumer channels. Whether those efforts move fast enough to serve the patients who relied on compounded alternatives remains the central question nobody in this fight is adequately answering.
For now, Novo Nordisk has the law, the FDA, and the DOJ on its side. Hims has a $49 price point and a Super Bowl ad about America’s “health gap.” The courts will decide which argument wins. The market already has its opinion.
