The news: Novo Nordisk filed a patent infringement lawsuit against Hims & Hers, accusing the company of unlawfully mass-marketing Novo’s GLP-1 drug semaglutide—the active ingredient in Wegovy and Ozempic.

Digging into the details: Novo alleges that Hims is selling products covered by Novo’s semaglutide patent (which expires in 2032 in the US) while marketing non-FDA-approved drugs as containing the same active ingredient as Wegovy and Ozempic—something Novo says is not possible because it does not sell semaglutide API for compounding.

Novo is asking the US District Court for the District of Delaware to permanently ban Hims from selling compounded drugs that allegedly infringe on Novo’s patents. It is also seeking to recover financial damages due to revenues lost. For context, Hims has continued offering compounded semaglutide after the FDA declared there was no longer a shortage of the (meaning: this regulatory exemption no longer applies). Hims has since relied on another regulatory exception allowing compounded drugs to be individualized for specific patient needs as determined by a doctor (e.g., removing an ingredient for allergies).

For its part, Hims said US patients rely on compounded drugs for personalized care and accused Big Pharma of using the courts to restrict consumer choice.

Why it matters: Novo has filed multiple lawsuits against compounders over false advertising and trademark claims, but this marks its first suit against Hims, and its first patent case. Legal experts say patent suits signal a higher-stakes battle that could result in greater damages.

Hims is also under heightened scrutiny from the FDA and the HHS.

• After Hims rolled out a compounded semaglutide pill, the FDA said it will move to restrict GLP-1 API used in non-FDA-approved compounded drugs being mass-marketed by companies. The FDA said it will target ads that claim compounded products use the same active ingredient as the FDA-approved drugs.
• The HHS said it is referring Hims to the Justice Department over potential violations of federal drug law tied to medication quality or safety.

For Hims, the decision to offer a compounded version of Novo’s new Wegovy pill—albeit only briefly—was a “tipping point,” Novo’s chief counsel told STAT. For context, Hims introduced a compounded semaglutide pill last week—only a month after Novo’s brand-name Wegovy pill launch—but stopped selling it just two days later after facing pressure from US health authorities and legal threats from Novo.

Enforcement from regulators or adverse outcomes in the Novo lawsuit that impair Hims’ ability to sell compounded weight loss drugs would be a major blow to its business. Roughly $420 million, or 37% of its H1 2025 revenue, came from GLP-1 offerings, a significant portion of which are compounded products. The combination of regulatory and legal headwinds is already spooking investors, with Hims’ stock plunging more than 30% after a brief bump following the launch of its compounded semaglutide pill.

Implications for the weight loss drug market: The developments over the last few days wouldn’t have happened if Hims hadn’t tempted fate by compounding a newly launched drug that wasn’t in shortage. Now, telehealth companies and compounded weight loss drug sellers are on notice. Hims’ decision to sell a Wegovy knockoff looks reckless and poorly timed—and could force a regulatory reckoning for the broader market. Players in the compounded GLP-1 market must rigorously review their product marketing language and brace for tighter oversight to confirm copycat GLP-1s are prescribed only under legitimate, physician-documented clinical criteria.

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