Hims & Hers began selling compounded semaglutide injections in May 2024
Hims & Hers moved into compounded semaglutide in May 2024; the FDA later closed the shortage loophole and Novo Nordisk is now suing to stop compounded copies.
Hims & Hers began selling compounded semaglutide injections in May 2024, taking advantage of a rule that allows pharmacies to compound versions of drugs on the FDA's official shortage list [1]. Ten days later, Novo Nordisk, which makes Ozempic and Wegovy, released an announcement saying it was escalating legal actions to protect patients from compounded semaglutide drugs [1]. That release did not name Hims & Hers directly, but it set out Novo's position against compounded copies [1].
The disagreement has since become a lawsuit. Novo is asking a court to permanently ban Hims from selling compounded versions of its drugs that infringe Novo's patents [1]. "Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA's gold standard review process," said John F. Kuckelman, Novo's senior vice president and group general counsel for global legal, intellectual property and security [1].
In the filing, Novo cited U.S. Patent No. 8,129,343, which covers the chemical structure of the semaglutide molecule and runs until December 2031 [1]. Novo also said its testing found that injectable semaglutide compounded by pharmacies contained impurities of up to 86% [1]. Those figures come from Novo's own testing [1].
How the market changed after the launch
In February 2025, the FDA declared the semaglutide shortage resolved, closing the legal route that had allowed compounded semaglutide, and gave compounding pharmacies until April 22, 2025 to stop production [1]. That same month, Hims advertised its semaglutide injections during the Super Bowl; the next day Novo ran a print ad in The New York Times and USA Today telling patients to "Check before you inject," showing a vial of compounded semaglutide [1].
In April 2025 the two companies announced a long-term collaboration for obesity care in which patients could reach NovoCare Pharmacy through the Hims & Hers platform, with all dose strengths of Wegovy and a Hims & Hers membership bundled at a single price [1]. Novo terminated the deal in June 2025, accusing Hims of illegally mass compounding its drugs under the false guise of personalization and using deceptive marketing [1]. In November 2025, Hims said on its third-quarter earnings call that it was in discussions with Novo to make Wegovy available on its platform [1]. The Wegovy pill launched in January 2026, and Hims was not on the partner list [1].
Hims announced its own compounded semaglutide pill a month later, at $49 for the first month and $99 per month after that, compared with $149 a month for Wegovy on TrumpRx [1]. The day after that announcement, the top lawyer for the Department of Health and Human Services, Mike Stuart, said on X that his office had referred Hims & Hers to the Justice Department for potential violations of the Federal Food, Drug and Cosmetic Act [1]. Hims said it would stop offering access to the treatment and pulled the pill two days after announcing it [1].
On the oral product, Novo has said the semaglutide molecule needs SNAC technology to pass through the stomach without being broken down by enzymes, and that Hims instead used liposomal technology, which the lawsuit calls untested and unproven [1]. Novo CEO Mike Doustdar said on an analyst call that patients would be wasting their money because without SNAC the medicine "just simply doesn't work" [1].
Why it matters for patients
Compounded semaglutide is made by compounding pharmacies rather than by Novo Nordisk, and Novo argues it does not go through the same FDA review as Ozempic and Wegovy [1]. Patients deciding between an FDA-approved product and a compounded one are weighing that difference in review, along with price: the compounded pill was announced at $49 for the first month and $99 after, while the article cites $149 a month for Wegovy on TrumpRx [1].
Availability has also shifted with the shortage. Compounding of semaglutide copies was tied to the FDA's shortage list, and that basis ended when the shortage was declared resolved in February 2025, with a production deadline of April 22, 2025 [1].
What happens next
The lawsuit asks for a permanent ban on Hims selling compounded versions of Novo's drugs that infringe its patents; no ruling has been reported [1]. The semaglutide patent at issue expires in December 2031 [1]. What the Justice Department does with the referral, and whether Novo and Hims resume talks about carrying Wegovy, have not been disclosed [1].
Sources
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