Novo Nordisk has filed a lawsuit against Hims & Hers, alleging that the direct-to-consumer telehealth company sold unapproved, compounded versions of Wegovy and Ozempic that infringe on Novo Nordisk’s U.S. patents and pose potential safety risks to patients. The Denmark-based drugmaker claims the compounded semaglutide products are not FDA-approved, may contain incorrect ingredient levels or impurities, and were misleadingly marketed as safe alternatives to its branded drugs. Novo Nordisk is seeking damages and a permanent injunction to stop Hims & Hers from selling the alleged infringing products.
Hims & Hers pushed back publicly, framing the lawsuit as an attempt by “Big Pharma” to limit consumer choice and access to personalized care. The company said compounded medications are a well-established part of U.S. pharmacy practice and argued it has a long track record of providing safe, affordable treatment options.
The lawsuit follows heightened regulatory scrutiny. In early February, Hims & Hers announced plans to offer a once-daily compounded semaglutide pill, prompting swift responses from federal officials. The Department of Health and Human Services referred the company to the Department of Justice for potential violations of the Federal Food, Drug, and Cosmetic Act, and the FDA issued a warning stating that compounded drugs are not FDA-approved and that Hims & Hers’ marketing may have been false or misleading. Within days, Hims & Hers said it would stop offering the compounded pill after discussions with industry stakeholders.
The dispute has also reopened tensions between the two companies. Last year, Novo Nordisk and Hims & Hers briefly partnered to offer Wegovy bundled with a Hims membership, but Novo later terminated the agreement, citing concerns about “illegal mass compounding and deceptive marketing.” Market reaction to the lawsuit was immediate, with Novo Nordisk shares rising about 3% and Hims & Hers stock dropping more than 20%.
Click here to read the original news story.