Danish pharmaceutical giant Novo Nordisk has filed a lawsuit against online telehealth company Hims & Hers, alleging the company has been illegally marketing unapproved copies of its Wegovy obesity treatments in violation of patent protections.
CNBC reports that Novo Nordisk announced Monday it is suing Hims & Hers Health, seeking a permanent injunction to stop the telehealth company from selling compounded versions of its weight loss drugs and demanding monetary damages for patent infringement. The lawsuit marks a major escalation in the battle between traditional pharmaceutical manufacturers and compounding pharmacies over access to popular obesity medications.
The Danish drugmaker wants the court to permanently bar Hims from marketing compounded medications containing semaglutide, the active ingredient in its blockbuster Wegovy and Ozempic products. Semaglutide remains under U.S. patent protection until 2032.
“This is a complete sham, and it has been a sham since the shortage ended,” said John Kuckelman, Novo’s group general counsel. “The fact is that their medicines are untested, and they’re putting patients at risk,” he added, noting that compounded drugs don’t undergo the same rigorous safety and quality verification required for FDA-approved pharmaceuticals.
The lawsuit comes days after Hims announced Saturday it would discontinue its newly launched oral obesity medication copycat following increased federal scrutiny and legal pressure. Hims had planned to offer the oral formulation for as little as $49 for the first month — roughly one hundred dollars less than Novo’s FDA-approved Wegovy pill.
Hims issued a strongly worded response, calling the suit “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care” and another instance of pharma companies “weaponizing the US judicial system to limit consumer choice.”
The market reaction was swift. Novo Nordisk shares rose more than three percent on the Copenhagen exchange, while Hims stock plummeted over 18 percent on the NYSE.
The dispute centers on a regulatory exception that allowed compounding pharmacies to produce copies of patented medications during official drug shortages. However, semaglutide is no longer designated as in shortage following Novo’s investments to expand manufacturing capacity. The Wegovy pill, launched in early January, has seen an explosive rollout with no supply constraints. Despite this, Novo estimated in January that roughly 1.5 million Americans still use compounded GLP-1 medications.
Hims has maintained its compounded semaglutide products are legal because they are “personalized” in dosage. Novo disputes this, accusing Hims of illegal mass compounding that exceeds legal boundaries.
“I would just say we do want an end to mass compounding, to unlawful mass compounding,” Kuckelman said, clarifying that Novo isn’t seeking to eliminate all compounding. Legitimate compounding, he explained, must be based on valid medical grounds for individual patients — such as a patient unable to swallow a standard pill or allergic to a specific ingredient — rather than producing large inventories of what are essentially dosage variations.
The lawsuit follows Friday’s FDA announcement that it planned enforcement measures against Hims regarding its obesity pill, including potentially restricting access to necessary ingredients and referring the company to the Department of Justice.
Kuckelman acknowledged that some telehealth platforms, like competitor Ro, “are doing the right things” by transitioning to provide genuine FDA-approved products. But others have resisted. “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,” he said.
Both Novo Nordisk and Eli Lilly have pursued aggressive legal strategies against compounding pharmacies over the past two years. Novo has filed approximately 130 lawsuits addressing deceptive marketing and consumer fraud related to compounded versions of its products. Eli Lilly has waged a similar campaign over tirzepatide, the ingredient in its Zepbound and Mounjaro medications, which is also no longer listed as in short supply.
Read more at CNBC here.
Lucas Nolan is a reporter for Breitbart News covering issues of free speech and online censorship.
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