Many Americans are turning to telehealth companies for more affordable alternatives to popular weight-loss drugs like Wegovy and Zepbound, often in the form of compounded medications. However, the legality and safety of these compounded drugs are now under scrutiny, as Novo Nordisk, the maker of Wegovy, has taken legal action against Hims & Hers, a prominent telehealth provider.
The dispute centers around compounded versions of GLP-1 drugs, which are used for both weight loss and the management of conditions like diabetes. While these compounded drugs initially filled a need during a shortage of brand-name medications, Novo Nordisk asserts that their continued sale, even after the FDA declared the shortage over in 2025, infringes on their patents and poses risks to patient safety. Approximately 1.5 million Americans are currently using compounded GLP-1 drugs, according to Novo Nordisk estimates.
On , Novo Nordisk filed a lawsuit against Hims & Hers, alleging patent infringement related to the sale of compounded Wegovy. Hims & Hers initially announced plans to offer a compounded version of Wegovy for as little as $49 per month, significantly lower than the price of the brand-name drug. However, following the lawsuit and threats of enforcement action from federal regulators, Hims & Hers reversed course and discontinued sales of its copycat Wegovy pill.
Novo Nordisk’s legal challenge isn’t simply about protecting its market share. John Kuckelman, Novo Nordisk’s group general counsel, emphasized the safety concerns surrounding compounded medications. “The fact is that their medicines are untested, and they’re putting patients at risk,” he stated, highlighting that the safety, efficacy, and quality of compounded drugs are not subject to the same rigorous verification processes as FDA-approved medications.
The situation highlights a broader tension between access to affordable healthcare and the need to ensure patient safety. Roughly one in eight Americans currently use a GLP-1 drug for weight loss, diabetes, or other conditions, and many struggle to afford these medications without adequate insurance coverage. Novo Nordisk and Eli Lilly have both taken steps to lower prices for cash-paying customers, but compounded drugs offered a potentially even more affordable option.
Novo Nordisk currently holds the exclusive FDA approval for an oral GLP-1 weight loss pill, Wegovy. This exclusivity is a significant market advantage, and the company has been rapidly scaling up production and distribution of the oral formulation. Executives noted during a recent investor call that over 50,000 weekly prescriptions for the oral Wegovy were being filled, with 90% of those customers paying with cash. The starting price for the Wegovy pill is $149, approximately $200 less than the injectable version.
However, this exclusivity is expected to end soon. Eli Lilly’s weight-loss pill, orforglipron, is anticipated to receive FDA approval in , potentially increasing competition and driving down prices further. Experts like Howie Forman, director of the MD/MBA program at Yale School of Management, believe that increased competition is already benefiting consumers, with prices for these medications decreasing over the past year.
The FDA is also taking a more active role in regulating the compounding of GLP-1 drugs. Following Hims & Hers’ announcement of its Wegovy pill, the agency stated it would take “decisive steps” against companies engaged in mass compounding of these medications. The agency referred Hims & Hers to the Justice Department for potential violations of the Federal Food, Drug, and Cosmetic Act.
Novo Nordisk’s own testing revealed concerning levels of impurities in compounded versions of Wegovy. Injectable compounded versions contained impurities up to 86%, while compounded pills had impurities as high as 75%. Even small amounts of impurities can compromise the safety and effectiveness of a drug.
While compounding pharmacies can play a legitimate role in tailoring medications for patients with specific needs – such as adjusting statin dosages – experts like Dr. Michael Snyder, an obesity specialist at FuturHealth, believe the current situation with GLP-1 drugs has become problematic. He described the market as “the Wild West,” expressing concern that many companies are selling these medications without adequate medical oversight.
Dr. Snyder emphasized the importance of comprehensive care for patients using these medications, including proper nutrition and monitoring for side effects. He cautioned against simply focusing on weight loss without addressing the underlying health issues and ensuring patients are receiving appropriate medical guidance. “My job is to keep people in the lane of reasonable weight loss,” he said. “I can make anyone lose a ton of weight, but doing it healthfully, that takes a little bit of work.”
The legal battle between Novo Nordisk and Hims & Hers, coupled with increased scrutiny from the FDA, signals a potential shift in the landscape of weight-loss medications. Novo Nordisk expects other compounding pharmacies to take note of the legal action and reconsider their practices. The future of affordable access to these medications remains uncertain, but the focus is increasingly turning towards ensuring patient safety and adherence to established regulatory standards.
