Novo Nordisk filed the lawsuit on Monday, seeking a permanent court injunction and damages, arguing that Hims & Hers is infringing its patents by offering a compounded version of the drug without the manufacturer’s authorisation. “There is now a growing chorus of parties that have said, ‘Enough is enough on the compounding situation in the United States,’” said Novo Nordisk’s general counsel John Kuckelman, pointing to widespread concerns about the scale of unapproved drug compounding.
The lawsuit follows Hims & Hers’ announcement that it would launch a semaglutide-based pill priced at just USD 49 per month — far below the price of the branded Wegovy product. The move quickly triggered a response from both the drugmaker and the U.S. Food and Drug Administration (FDA), which said it would take steps to restrict the use of GLP-1 ingredients in unapproved compounded medicines and referred the matter to the Department of Justice over potential violations of federal law.
As a result, Hims & Hers decided to suspend the offering of the pill and to “stop offering access to this treatment” after discussions with industry stakeholders, the company told Reuters. The product had not been approved by the FDA and was not supported by clinical trial data, which was one of the regulator’s main objections to the practice of compounded production.
The developments had an immediate impact on financial markets. Shares of Hims & Hers fell nearly 20% after the withdrawal of the pill and news of the lawsuit, while Novo Nordisk’s shares rose by around 5% following reports of legal action and regulatory intervention. Market analysts note that the dispute has reshaped risk perceptions surrounding low-cost, compounded GLP-1 therapies.
The case has broader implications for U.S. patients and the healthcare system than it might initially appear. Semaglutide-based medicines have become a cornerstone of obesity and metabolic disease treatment in the United States, and surging demand has fuelled a market for cheaper alternatives offered by compounding pharmacies. The positions taken by regulators and manufacturers highlight growing tensions between access and affordability, patient safety, and the protection of intellectual property rights and the integrity of the drug-approval system.