The Danish pharmaceutical company Novo Nordisk is taking legal action against the US telemedicine company Hims & Hers in order to stop the distribution of unauthorized copies of semaglutide.
• Novo Nordisk files suit for infringement of US patent 8,129,343
• Hims & Hers halts plans after regulatory pressure from FDA
• Analysis by Danish researchers reveals massive contamination in copy preparations
Escalation in the billion-dollar market for GLP-1 preparations
Novo Nordisk filed a comprehensive lawsuit against US telemedicine provider Hims & Hers on February 9, 2026, the Danes announced in a press release. The core of the legal dispute is the allegation that the US company is systematically infringing US patent 8,129,343 with its individually manufactured (“compounded”) semaglutide products. This move comes hot on the heels of Hims & Hers’ announcement that it would offer a significantly cheaper, oral version of the active ingredient that forms the basis for the blockbuster drugs Wegovy and Ozempic. While Novo Nordisk defends its market position through technological innovations such as SNAC technology for the oral absorption of active ingredients, the group sees Hims & Hers’ offerings as an illegal mass production of unapproved imitation preparations.
Serious allegations regarding patient safety and quality
In addition to the patent law aspects, Novo Nordisk raises massive concerns about patient safety. In an official statement, the company announced that its own laboratory tests have detected contamination levels of up to 86 percent in third-party injectable semaglutide products. For oral variants, this value was up to 75 percent, which represents a significant risk of life-threatening immune reactions such as anaphylactic shock. John F. Kuckelman, senior vice president and group general counsel at Novo Nordisk, emphasized in the release that Hims & Hers was “circumventing the gold standard of the FDA review process” and thereby endangering public health. The group is asking the court for a permanent ban on the sale of the products in question and for the payment of damages.
Regulatory pressure and withdrawal of the semaglutide pill
At the weekend, Hims & Hers was forced to cancel the planned distribution of its recently introduced semaglutide pill. This was preceded by a clear warning from the US Food and Drug Administration (FDA), which announced on February 6, 2026 that it would take greater action against the mass marketing of unapproved GLP-1 copies. According to a report by Reuters, the US Department of Health and Human Services has also referred the case to the Department of Justice to investigate possible violations of federal law. In a statement on Platform
Stock reactions from Novo Nordisk and Hims & Hers: Volatility shapes trading
The legal disputes are leaving a clear mark on international trading venues. Shares in Novo Nordisk were on the rise in today’s trading on the Copenhagen Stock Exchange, ultimately trading at DKK 314.95, up 1.27 percent. Investors are thus honoring the determined defense of intellectual property and securing market shares in the highly profitable obesity segment. In contrast, the Hims & Hers shares remain under massive selling pressure. After a double-digit price drop the day before, the stock temporarily slipped by a further 5.82 percent to $18.21 on the NYSE.
Editorial team finanzen.net
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