Additional Coverage:
- Novo Nordisk sues Hims & Hers over copycat versions of Wegovy drugs; Hims stock falls 18% (cnbc.com)
Novo Nordisk Sues Hims Over Compounded Obesity Drugs, Escalating Legal Battle
Novo Nordisk has filed a lawsuit against Hims & Hers Health, Inc., seeking a permanent injunction to prevent the telehealth company from selling compounded versions of its patented drugs and demanding damages. This move intensifies the ongoing dispute between the two pharmaceutical entities, particularly concerning the burgeoning market for obesity treatments.
The legal action follows Hims’ recent announcement that it would cease offering its newly launched “copycat” oral obesity pill. This decision came after scrutiny from federal regulators and prior legal threats from Danish drugmaker Novo Nordisk. Hims had initially planned to offer its compounded oral drug for as little as $49 for the first month, significantly undercutting the price of Novo Nordisk’s FDA-approved Wegovy pill.
John Kuckelman, Novo Nordisk’s group general counsel of global legal, intellectual property, and security, sharply criticized Hims’ practices in an interview. “This is a complete sham, and it has been a sham since the shortage ended,” Kuckelman stated, adding, “The fact is that their medicines are untested, and they’re putting patients at risk.” He emphasized that compounded medicines lack verification from U.S. regulators regarding their safety, efficacy, and quality.
In response to the lawsuit, Hims issued a statement on Monday, calling it “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care.” Hims accused “Big Pharma” of “weaponizing the US judicial system to limit consumer choice” and reiterated its “long history of providing safe access to personalized healthcare” to patients.
Following the news, Novo Nordisk’s Copenhagen-listed shares saw a more than 3% increase, while Hims’ NYSE-listed stock experienced a decline of over 18%.
The lawsuit is part of Novo Nordisk’s broader strategy to secure its market share in the rapidly expanding obesity drug sector and counter competition from both established players and a surge of compounded alternatives. These copycat drugs have proliferated under a regulatory loophole that permits companies like Hims to sell compounded versions of patent-protected drugs when branded treatments are in short supply.
Semaglutide, the active ingredient in Novo Nordisk’s oral pill and its popular injectable medications, is no longer in shortage in the U.S., largely due to the company’s efforts to increase manufacturing capacity. There are no reported shortages for the Wegovy pill, which has seen a strong launch since its introduction to the U.S. market in early January. Despite this, Novo Nordisk estimated in January that approximately 1.5 million Americans are currently using compounded GLP-1 drugs.
Hims has maintained that its compounded pill and other GLP-1 products contain semaglutide, asserting that its versions are legal due to their “personalized” dosage, even though the ingredient is protected by U.S. patents until 2032. Novo Nordisk, however, contends that it does not directly or indirectly sell semaglutide for copycat products and has accused Hims of engaging in illegal mass compounding.
“I would just say we do want an end to mass compounding, to unlawful mass compounding,” Kuckelman clarified, stressing that Novo Nordisk is not aiming to halt all compounding practices. He explained that legitimate compounding must be based on genuine medical necessity, “as opposed to you producing mass stocks of what you’re calling a personalized medicine, which is really just a dosage variation.” Compounded drugs are typically produced on a case-by-case basis when a doctor determines it is medically necessary for a patient, such as in cases of allergies to specific ingredients or difficulty swallowing pills.
The legal action also follows the Food and Drug Administration’s (FDA) announcement on Friday that it plans to take legal action against Hims regarding its pill, including restricting access to ingredients and referring the company to the Department of Justice for potential violations.
Kuckelman noted that some telehealth platforms, such as Ro, “are doing the right things” by transitioning to providing patients with FDA-approved products from Novo Nordisk and its competitors. However, he added, “some won’t, and the only way it appears that we’re going to get Hims and others to stop this is through hopefully government enforcement actions and through lawsuits like the one that we’ve filed today.”
Novo Nordisk and Eli Lilly have been aggressively pursuing legal action against compounding pharmacies over the past two years, as their weight loss and diabetes drugs gain immense popularity. Kuckelman indicated that Novo Nordisk has filed approximately 130 lawsuits concerning deceptive marketing practices and consumer fraud. Eli Lilly has undertaken a similar legal process regarding tirzepatide, the active ingredient in its weight loss drug Zepbound and diabetes treatment Mounjaro, which is also no longer in short supply in the U.S.