Lawsuit targets compounded obesity treatments
Novo Nordisk said Monday it has filed a lawsuit against online telehealth company Hims & Hers, accusing the firm of illegally mass marketing cheaper, unapproved copies of its new Wegovy obesity pill and injections in the United States.
The Danish drugmaker is asking a U.S. court to permanently ban Hims from selling compounded versions of its obesity drugs that it says infringe on Novo’s patents. The company is also seeking financial damages.
“This is a complete sham, and it has been a sham since the shortage ended,” said Novo’s group general counsel for global legal, intellectual property and security, arguing that the compounded medicines are untested and pose risks to patients.
Escalating dispute in a booming market
The lawsuit escalates a growing feud between the two companies as competition intensifies in the rapidly expanding obesity drug market. Hims said over the weekend that it would stop offering its newly launched oral obesity pill after facing regulatory scrutiny and legal pressure.
Hims had planned to sell the pill for as little as $49 for the first month, undercutting Novo’s approved Wegovy pill by roughly $100. In response to the lawsuit, Hims called the legal action “a blatant attack” on Americans who rely on compounded medications for access to personalized care.
The company added that it has a long history of providing what it described as safe and individualized healthcare solutions.
Regulatory backdrop and market reaction
Shares of Novo Nordisk rose more than 3% following news of the lawsuit, while Hims & Hers stock fell more than 27%. The legal action comes as Novo seeks to regain market share and protect its intellectual property amid competition from rival pharmaceutical firms and compounded alternatives.
Compounded versions of branded drugs have proliferated under a regulatory loophole that allows pharmacies to produce alternatives when approved medications are in short supply. Novo says that shortage has now ended for semaglutide, the active ingredient in Wegovy, after it significantly expanded manufacturing capacity.
Despite this, Novo estimates that about 1.5 million Americans are still using compounded GLP-1 drugs.
Patent claims and mass compounding concerns
Novo argues that semaglutide is protected by U.S. patents through 2032 and says it does not sell the ingredient directly or indirectly to compounders. The company alleges Hims is engaging in unlawful mass compounding by producing large quantities under the guise of personalization.
Compounded drugs are typically permitted only on a case-by-case basis when a physician determines they are medically necessary, such as for patients with allergies or difficulty swallowing standard pills.
Broader enforcement actions underway
The lawsuit follows an announcement from the Food and Drug Administration that it plans to take legal action against Hims related to its compounded obesity pill, including possible referrals to the Department of Justice.
Novo said it has filed roughly 130 lawsuits in recent years targeting deceptive marketing and consumer fraud tied to compounded versions of its drugs. Other pharmaceutical companies have taken similar steps as demand for weight loss and diabetes treatments continues to surge.