Novo Nordisk A/S (NVO) announced Monday that it's taking telehealth company Hims & Hers Inc. (HIMS) to court, alleging patent infringement over Hims' compounded semaglutide products sold in the U.S. market. The lawsuit centers on U.S. Patent 8,129,343, which covers the Danish pharmaceutical giant's blockbuster weight loss treatment.

The timing is interesting. Novo Nordisk also got a stock bump Monday after launching its previously announced share repurchase program, part of a broader buyback initiative worth up to 15 billion Danish kroner that will run for 12 months starting February 4, 2026.

What's Really Behind the Lawsuit

According to Novo Nordisk, this isn't just about patent protection. The company claims Hims & Hers has been running promotional campaigns that mislead both consumers and healthcare providers about the safety and clinical benefits of unapproved compounded drugs.

Here's where it gets messy: Hims recently launched what it called a "Compounded GLP-1 Pill" and then abruptly pulled it just two days later. That discontinuation came right after Novo Nordisk introduced the Wegovy pill, the first and only FDA-approved GLP-1 pill for weight loss. The timing raised eyebrows.

But Novo says the real problem isn't the discontinued pill. The company alleges that Hims continues to mass-produce injectable versions made with inauthentic active pharmaceutical ingredients (API), essentially creating knock-offs that put patients at risk.

"Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA's gold standard review process – that's dangerous and deceptive to patients," said John Kuckelman, SVP, Group General Counsel, Global Legal, IP and Security at Novo Nordisk. "We've taken legal action to protect the American public and our intellectual property."

The core issue, according to Novo, is that aggressive marketing by Hims and compounding pharmacies has flooded the market with versions of Wegovy and Ozempic that haven't gone through proper FDA approval. These compounded products may contain dangerous impurities or incorrect dosages, potentially causing life-threatening immune responses, severe drug interactions, hospitalizations, and even overdoses.

The Impurity Problem

The numbers are striking. Novo Nordisk conducted its own testing and found that injectable semaglutide drugs made by compounding pharmacies contained impurities up to 86%. The compounded oral versions weren't much better, with impurity levels as high as 75%.

Even small amounts of impurities can create serious problems, affecting both the safety and effectiveness of medications. In some cases, these impurities can trigger unwanted immune responses, including anaphylactic shock.

The FDA itself weighed in on this issue just last Friday, explaining that compounded GLP-1 drugs mass-marketed by Hims and other compounding pharmacies are "drugs for which the FDA cannot verify quality, safety, or efficacy." That's regulatory speak for: we have no idea what's actually in these products.

Market Reaction

Investors responded decisively to the news. NVO stock climbed 6.84% to $50.90, while HIMS stock tumbled 26.93% to $16.83 in Monday trading, according to market data.

The lawsuit highlights the ongoing tension in the booming weight loss drug market, where demand for GLP-1 medications has far outstripped supply. That shortage created an opening for compounding pharmacies and telehealth companies to step in with their own versions, but pharmaceutical companies like Novo Nordisk are pushing back hard on what they see as a safety issue wrapped in a patent dispute.