novo nordisk announced Monday that it would sue the online telemedicine provider. him and her Cheap, unapproved copies of drug company’s new Wegovy obesity drugs and injectables for mass sale in the US
Novo is asking the court to permanently bar Hims from selling a formulated version of the drug that infringes its patents, and is seeking damages.
“This is a complete sham, and has been a sham ever since the supply shortage ended,” John Kuckelman, Novo’s group general counsel for global legal, intellectual property and security, said in an interview.
He noted how the safety, efficacy, and quality of compounded medicines are not verified by U.S. regulators, adding: “The fact is that their medicines are not tested and they are putting patients at risk.”
The move further escalates the feud between Novo and Hims, with the company announcing on Saturday that it would stop offering its new copycat obesity drug after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims planned to offer the oral drug for just $49 the first month, about $100 less than Novo’s approved Wigovy pill.
Novo Nordisk’s Copenhagen-listed shares rose more than 5%, while Hims’ New York Stock Exchange-listed shares were down 21% on the market as of 8 a.m. ET.
The lawsuit comes as Novo seeks to regain market share in the fast-growing obesity drug market and fend off competition from both countries. Eli Lilly and a wave of complex alternatives. These counterfeits have proliferated under regulatory loopholes that allow companies like Hims to sell compounded versions of patent-protected drugs when branded treatments are in short supply.
Semaglutide, the active ingredient in Novo’s tablets and its blockbuster injection, is no longer in short supply in the United States, thanks to the company’s efforts to increase manufacturing capacity. Wegovy tablets have been a hit since entering the U.S. market in early January, with no shortages reported.
Still, Novo estimated in January that as many as 1.5 million Americans are using complex GLP-1 drugs.
Hims claimed that its combination tablets and other GLP-1 products contain semaglutide, even though that ingredient is protected by a U.S. patent until 2032. Hims said its product is legal because the doses are “individualized.”
However, Novo said it would not directly or indirectly sell semaglutide to counterfeit products and accused Hims of engaging in illegal mass compounding.
“I just want to say we want to end mass compounding, illegal mass compounding,” Kuckelman said, noting that Novo is not trying to end all compounding.
He said compounding must be based on sound evidence, “rather than producing large quantities of what are called personalized medicines, which are really just different doses.”
Combination medications can be made on a case-by-case basis if a doctor determines it is medically necessary for a patient, such as if the patient cannot swallow a pill or is allergic to a particular ingredient in a brand-name drug.
On Friday, the Food and Drug Administration announced it would take legal action against Hims regarding the pill, including restricting access to its ingredients and reporting potential violations to the Department of Justice.
Kuckelman said some telemedicine platforms, such as Ro, are “doing the right thing” by moving to provide patients with genuine FDA-approved products from Novo and its competitors.
But, he said, “some people won’t, and the only way to get Hims and others to stop this is through government enforcement, preferably through lawsuits like the one we filed today.”
Novo and Lilly have been aggressively cracking down on compounding pharmacies over the past two years, benefiting from the soaring popularity of their weight loss and diabetes drugs. Novo has filed about 130 lawsuits dealing with deceptive marketing practices and consumer fraud, Kuckelman said.
Lilly is going through similar legal proceedings for tirzepatide, the active ingredient in its weight-loss drug Zepbound, and its diabetes drug Munjaro, which is already in short supply in the United States.
