Compounding

Hims & Hers launches compounded semaglutide injections

Hims & Hers began selling compounded GLP-1 injections in May 2024 under a shortage loophole, starting a two-year fight with Novo Nordisk that has now reached federal court [1].

By the Semaglutides news desk·
Ozempic
Image: drugdiscoverytrends.com

Hims & Hers began selling copycat GLP-1 injections in May 2024, using a legal loophole that lets compounding pharmacies make versions of drugs listed on the FDA's official shortage list [1]. The move made the telehealth company the most visible consumer face of the compounded semaglutide market — and put it on a collision course with Novo Nordisk, the maker of Ozempic and Wegovy.

Novo Nordisk responded quickly. Ten days after the Hims & Hers launch, the company put out an announcement saying it was escalating legal action to protect patients from compounded semaglutide products [1]. That statement did not name Hims & Hers directly, but it laid out Novo's position against compounded copies [1].

The conflict became public in a bigger way in February 2025, when Hims & Hers advertised its semaglutide injections in a Super Bowl commercial [1]. The next day, Novo Nordisk ran print ads in The New York Times and USA Today telling patients to "Check before you inject," with an image of a vial of compounded semaglutide [1].

The loophole closes

The legal basis for large-scale compounding depended on the shortage. The FDA declared the semaglutide shortage resolved in February 2025 and gave compounding pharmacies until April 22, 2025 to stop production [1].

What followed was a short truce. In April 2025, Novo Nordisk and Hims & Hers announced a long-term collaboration to expand access to obesity care, letting patients reach NovoCare Pharmacy through the Hims & Hers platform with a bundle of all Wegovy dose strengths plus a membership at a single price [1]. The two companies said they were "developing a roadmap" to combine Novo's treatment with Hims & Hers' ability to scale access [1]. The deal lasted less than two months. Novo Nordisk terminated it in June 2025, accusing Hims & Hers of illegal mass compounding "under the false guise of personalization" and deceptive marketing [1].

Novo has since said its own testing found injectable semaglutide compounded by pharmacies contained impurities of up to 86% [1]. The company also says compounded knockoffs may contain incorrect amounts of active ingredient [1]. Those figures come from Novo Nordisk's own statement, not from an independent regulator, and the sources here do not include a response from compounders to that specific testing claim.

The dispute escalated again in 2026. Hims & Hers launched a compounded semaglutide pill at $49 for the first month and $99 per month after that — below the $149 per month price for Wegovy on TrumpRx [1]. A day later, HHS general counsel Mike Stuart said his office had referred Hims & Hers to the Justice Department for potential violations of the Federal Food, Drug and Cosmetic Act, and Hims said it would stop offering the product [1]. Novo Nordisk then sued, asking a court to permanently bar Hims & Hers from selling compounded versions that infringe U.S. Patent No. 8,129,343, which covers the semaglutide molecule itself and runs until December 2031 [1].

Why it matters for patients

For people who started GLP-1 treatment through a telehealth platform in 2024 or 2025, this history explains why access kept changing. Compounded semaglutide was legal at scale only while the FDA listed a shortage; once that ended in February 2025, with a cutoff of April 22, 2025, the ground shifted [1].

It also shows how quickly a source of medication can disappear. The Novo–Hims partnership ended after less than two months [1], and the compounded pill was pulled two days after launch [1].

The safety questions are unsettled in public. Novo says compounded injectables it tested had impurities up to 86% [1]; whether that applies to any specific pharmacy's product is not stated in the available sources.

What happens next

Novo Nordisk's patent suit seeks a permanent ban on Hims & Hers selling infringing compounded semaglutide [1]. The HHS referral to the Justice Department is also pending, with no announced outcome in the sources [1]. Patent '343 expires in December 2031 [1].

Sources

  1. https://www.drugdiscoverytrends.com/novo-nordisk-sues-hims-for-glp-1-patent-infringement

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