Novo Nordisk earlier accused Hims & Hers of illegal mass compounding and threatened legal and regulatory action|@hims|Instagram
After drawing backlash and legal threats from regulators as well as from drugmaker Novo Nordisk, Hims & Hers said on Saturday that it will withdraw its compounded weight-loss pill from the market.
The move comes just three days after it announced that it would sell a $49 version of Novo’s Wegovy pill, using the same active ingredient, semaglutide.
In a social media post, the company said it held “constructive conversations” with industry stakeholders and decided to stop offering the treatment. It added that it remains focused on providing safe, affordable, and personalized care to millions of users.
Novo Nordisk earlier accused Hims & Hers of illegal mass compounding and threatened legal and regulatory action.
The company said regulators had previously warned Hims about deceptive advertising tied to knock-off GLP-1 products.
On Friday, the Food and Drug Administration escalated the dispute. The agency said it plans to restrict access to ingredients and refer the company to the Department of Justice.
Novo Nordisk rolled out an oral version of Wegovy last month, using semaglutide and its proprietary SNAC technology to aid absorption. Following Hims & Hers’ announcement of a rival pill, industry observers were curious about its ability to avoid conflicts with Novo’s patents.
The role of compounding pharmacies
Compounding pharmacies can customize drugs even without FDA approval. During shortages, they could make near-copies, fueling the rise of off-brand GLP-1 injectables after Ozempic, Wegovy, Mounjaro, and Zepbound ran short in 2022. Once the shortages were over, the copycats were ordered by the FDA to stop, though the space for customized formulations continues to thrive.
Despite the controversy, Hims & Hers said it complies with the law. The decision comes just before the company runs a national Super Bowl advertisement.