Novo Nordisk is pursuing legal action against Hims & Hers Health, escalating a dispute over compounded versions of the company’s weight-loss drug Wegovy. The lawsuit, filed Monday, alleges patent infringement and deceptive practices related to the sale of semaglutide-based medications, following Hims & Hers’ brief attempt to market an oral copy of Wegovy.
The legal move comes after Hims & Hers announced over the weekend it would cease offering the compounded oral version of Wegovy, responding to both legal threats from Novo Nordisk and concerns raised by the U.S. Food and Drug Administration (FDA). The FDA had signaled its intention to restrict the use of GLP-1 ingredients in compounded drugs, citing safety and quality concerns.
Novo Nordisk alleges that Hims & Hers misled consumers and healthcare professionals regarding the clinical benefits and safety of these unapproved medications. “Hims engaged in promotional campaigns touting its compounded semaglutide products, deceiving consumers and healthcare professionals about the clinical benefits and safety of these unapproved drugs,” the company stated in a press release. The Danish pharmaceutical company likewise continues to challenge the sale of compounded injectable versions of its drugs.
The dispute centers on compounded drugs, which are custom-made medications created by pharmacies, often in response to drug shortages or to offer alternative formulations. While the FDA temporarily allowed pharmacies to compound versions of Wegovy and Ozempic due to limited production capacity, Novo Nordisk argues that the continued availability of these compounded drugs undermines its market and potentially endangers patients.
Novo Nordisk claims its own testing revealed significant impurities in compounded semaglutide products. According to the company, injectable versions contained up to 86% impurities, while oral formulations had up to 75%. “Even in small amounts, these impurities can have a negative impact on the safety and efficacy of a medicine, including causing undesirable immune reactions such as anaphylactic shock,” Novo Nordisk warned.
The legal battle unfolds as Novo Nordisk’s stock experienced volatility following a recent announcement of lower-than-expected growth projections for 2026. The company anticipates a 5% to 13% decline in sales, excluding currency effects, and a similar drop in operating profit. This forecast was influenced by increased competition from compounded drugs and, separately, the anticipated impact of a fresh pricing agreement with the U.S. Government.
The “Most Favored Nations” (MFN) rule, initiated by the Trump administration, aims to lower drug prices in the U.S. By requiring manufacturers to offer the lowest prices available in other developed countries. The Biden administration has continued to implement the rule, with Wegovy cited as an example of a drug expected to spot a price reduction from $1,350 to $350 per month for eligible patients enrolled in Medicare and Medicaid programs. Citi analysts estimate the MFN rule will negatively impact Novo Nordisk’s revenue by a low single-digit percentage.
Hims & Hers initially launched its oral semaglutide product at $49 per month, significantly undercutting the price of branded Wegovy. The company stated it made the decision to halt sales after “constructive discussions with stakeholders in the industry.”
Novo Nordisk has requested a court order to permanently prevent Hims & Hers from selling infringing compounded drugs and is seeking financial damages.
