Novo Nordisk sues Hims & Hers over compounded semaglutide patent

Novo Nordisk sued the telehealth company Hims & Hers on February 9, 2026, alleging that its compounded semaglutide products infringe U.S. Patent 8,129,343. Novo is asking the court to permanently bar Hims from selling compounded drugs that infringe its patents and to award damages ^[1][3][5]. The patent covers semaglutide in oral, injectable and other forms, and it expires in 2032 ^[4].

The filing came two days after Hims & Hers pulled a compounded semaglutide pill it had just launched. Novo said Hims launched its "Compounded GLP-1 Pill" and then abruptly discontinued it two days later, shortly after Novo introduced the Wegovy pill, which Novo describes as the first and only FDA-approved GLP-1 pill for weight loss ^[1]. Reuters reported the Hims pill was priced at $49 and was canceled after pushback from U.S. authorities ^[3]. STAT reported the $49 price applied to the first five months, undercutting the $149 Novo charges for its approved pill ^[4]. CNBC reported the $49 price applied to the first month, roughly $100 less than Novo's pill ^[5]. The outlets described the pricing differently, and the exact terms of the withdrawn offer have not been reconciled in these accounts.

Novo said its own testing found impurity levels as high as 86% in compounded injectable semaglutide and up to 75% in compounded oral versions ^[1][2]. The company said such impurities may lead to immune reactions, hospitalization, severe drug-drug interactions, overdoses and anaphylactic shock ^[2]. Novo also alleged that Hims continues to mass compound injectables made with "inauthentic" active pharmaceutical ingredients ^[1][2]. Hims has said its products contain semaglutide and that its versions are legal because they are "personalized" in dosage ^[5].

Hims 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" ^[3][5]. Novo's general counsel, John Kuckelman, said the company wants "an end to mass compounding, to unlawful mass compounding," and that Novo is not trying to stop all compounding ^[5].

Reuters, citing analysts, said the lawsuit and the FDA response could mark a broader crackdown on compounded GLP-1s. Novo has sued compounders before over trademark claims, but this is its first U.S. patent case against a compounder, according to Reuters ^[3]. Kuckelman said Novo has filed around 130 lawsuits involving deceptive marketing and consumer fraud ^[5]. Novo estimated in January that as many as 1.5 million Americans use compounded GLP-1 drugs ^[5].

Shares moved on the news. Reuters reported Novo's Copenhagen-listed shares rose 5% and Hims fell 20% ^[3]; CNBC reported Novo's shares climbed more than 3% and Hims fell more than 18% ^[5]. The two accounts differ on the size of the moves.

The FDA said on February 6, 2026, that it intends to restrict GLP-1 active pharmaceutical ingredients used in compounded drugs that are mass marketed, describing such products as drugs "for which the FDA cannot verify quality, safety, or efficacy," and named Hims & Hers ^[2][5][6]. The agency warned that companies making or marketing unapproved compounded GLP-1 drugs could face seizure and injunction without further notice ^[2][6]. In September 2025, the FDA issued more than 55 warning letters to online sellers of compounded GLP-1s over misleading advertising ^[6].

Why it matters for patients

Compounded semaglutide is not an FDA-approved drug. The agency says it cannot verify the quality, safety or efficacy of compounded products, and that companies may not claim they are generic versions of approved drugs, contain the same active ingredients, or are clinically proven to produce the same results ^[2].

The legal basis that allowed widespread compounding during shortages has narrowed. Novo says all doses of Wegovy and Ozempic are fully available nationwide, and there are no reported shortages of the Wegovy pill ^[2][5]. Compounding is generally permitted case by case when a prescriber determines it is medically necessary for an individual patient, such as when a patient cannot swallow a pill or is allergic to an ingredient in a branded drug ^[5].

For patients deciding where to fill a prescription, the practical question is whether the product dispensed is an FDA-approved medicine or a compounded version. Prescribers and pharmacies can confirm which one is being provided. Prices vary widely: the sources describe compounded pills at $49, FDA-approved semaglutide tablets at $149 to $299 a month on the TrumpRx site, and a listed $1,349 ^[4][5][6].

What happens next

No court schedule, hearing date or ruling in the patent case has been reported. The FDA has said it may act without further notice ^[2][6]. Eli Lilly's oral GLP-1 pill, orforglipron, is expected to receive FDA approval in April 2026 ^[3]. A March 11, 2026 report says Novo dropped the patent lawsuit after Hims & Hers agreed to stop promoting compounded GLP-1 products and to offer FDA-approved Ozempic and Wegovy instead; that report did not include additional terms ^[2].