Novo Nordisk has filed a lawsuit against online telehealth provider Hims & Hers, accusing the company of illegally marketing unapproved and cheaper copies of its Wegovy obesity treatments in the United States. The legal action highlights growing tensions in the fast-expanding weight loss drug market, where branded pharmaceutical companies are clashing with telehealth platforms and compounding providers.
Allegations and legal action
The Danish drugmaker is asking a U.S. court to permanently ban Hims from selling compounded versions of its drugs that allegedly infringe on Novo Nordisk’s patents. The company is also seeking damages, arguing that mass-produced compounded drugs violate patent protections and regulatory standards.
Novo Nordisk’s legal counsel stated that the compounded products are untested and pose potential risks to patients, as their safety, efficacy, and quality are not verified by U.S. regulators. According to the company, the justification for compounding no longer applies now that Wegovy and related products are no longer in shortage.
Hims’ response and market impact
Hims & Hers rejected the lawsuit, calling it an attempt by a major pharmaceutical company to limit consumer choice. The telehealth firm said it provides personalized healthcare and that compounded medications play a crucial role in access and affordability for many patients.
The dispute has had an immediate market impact. Novo Nordisk’s shares rose more than 3% following the announcement, while Hims’ stock fell sharply. Over the weekend, Hims said it would stop offering its copycat obesity pill after facing increased scrutiny from regulators and legal pressure.
Regulatory scrutiny and FDA involvement
The lawsuit comes amid growing attention from U.S. regulators. The Food and Drug Administration recently announced plans to take legal action against Hims related to its compounded obesity pill, including restricting access to key ingredients and referring the matter to the Department of Justice.
Compounded drugs are typically allowed on a case-by-case basis when medically necessary, such as when patients cannot tolerate approved formulations. Novo Nordisk argues that producing large quantities of dosage variations does not meet that standard and constitutes unlawful mass compounding.
Broader competition in the obesity drug market
The case reflects intensifying competition in the obesity and diabetes treatment space. As demand for GLP-1 drugs continues to surge, pharmaceutical companies are working to protect market share against both branded rivals and compounded alternatives. Novo Nordisk estimates that more than one million Americans are currently using compounded GLP-1 drugs, even as branded supplies stabilize.
Conclusion
Novo Nordisk’s lawsuit against Hims & Hers underscores the legal and regulatory battles emerging around obesity treatments. As shortages ease and demand remains high, the outcome of this case could shape how compounded drugs are regulated and how telehealth platforms operate within the pharmaceutical marketplace.
