Danish pharmaceutical giant Novo Nordisk has filed a patent infringement lawsuit against telehealth company Hims & Hers, accusing it of mass marketing unapproved compounded versions of its blockbuster weight-loss drugs Wegovy and Ozempic. The lawsuit, filed on Monday, targets both an oral semaglutide pill that Hims had briefly offered for as little as 49 dollars per month and injectable formulations sold through its platform. Novo Nordisk is asking the court to permanently ban Hims from selling the products and to award damages that could reach hundreds of millions of dollars. The case marks Novo Nordisk's first United States patent infringement action against a compounding pharmacy.
At the heart of the dispute is U.S. Patent 8,129,343, which covers semaglutide, the active ingredient in both Wegovy and Ozempic. The patent does not expire until 2032, giving Novo Nordisk exclusive rights to the compound for several more years. Hims & Hers had launched its compounded semaglutide pill just days earlier at an introductory price of 49 dollars per month, significantly undercutting Novo Nordisk's approved Wegovy pill, which retails at 149 dollars. Hims announced over the weekend that it would discontinue the pill, stating it had held constructive conversations with stakeholders across the industry.
Novo Nordisk raised serious safety concerns about compounded semaglutide products in its press release accompanying the lawsuit. The company said its own laboratory testing found that injectable semaglutide drugs compounded by pharmacies contained impurities of up to 86 percent, while compounded oral semaglutide products contained impurities as high as 75 percent. John F. Kuckelman, Novo Nordisk's senior vice president of global legal, stated that patient safety has always been the company's top priority and called the lawsuit a wake-up call for all compounding pharmacies selling unauthorized versions of its medicines.
The lawsuit comes amid a broader crackdown by United States regulators on compounded weight-loss drugs. On Friday, the Food and Drug Administration issued warnings about compounded GLP-1 medications, and the Department of Health and Human Services referred the matter to the Department of Justice for investigation into potential violations of the Federal Food, Drug, and Cosmetic Act. FDA Commissioner Marty Makary pledged swift action against what he described as illegal copycat drugs. The regulatory loophole that had allowed compounders to sell versions of patented drugs during supply shortages has effectively closed, as Novo Nordisk has ramped up manufacturing capacity and semaglutide is no longer listed as being in shortage.
Financial markets reacted sharply to the news. Hims & Hers shares plummeted more than 18 percent on Monday, while Novo Nordisk's Copenhagen-listed stock climbed over 3 percent. Novo Nordisk's general counsel indicated that the company could seek trebled damages potentially reaching hundreds of millions of dollars depending on how the case unfolds. The two companies had previously partnered to improve drug affordability but ended their relationship when Hims continued offering compounded semaglutide. Industry analysts said the case could set a significant precedent for the booming weight-loss drug market, which is projected to exceed 150 billion dollars globally by 2030.
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