Novo Nordisk sues Hims & Hers over compounded obesity drugs

Novo Nordisk He said he would sue the online telehealth provider on Monday His and Hers To mass market cheaper, unapproved copies of the drugmaker’s new Wegovy obesity pill and injections in the US

Novo is asking the court to permanently ban Hims from selling compounded versions of its drugs that infringe the company’s patents and is seeking damages. In a statement, Novo accused Hims of “deceiving patients and putting their health at risk” because the safety, effectiveness and quality of these copies had not been verified by US regulators.

The move adds to the feud between Novo and Hims, which said Saturday it would stop offering its new obesity pill copycat after facing scrutiny from federal regulators and legal threats from the Danish drugmaker. Hims had planned to offer the oral drug for as little as $49 for the first month; this was roughly $100 less than Novo’s approved Wegovy pill.

The lawsuit comes as Novo tries to regain market share in the growing obesity drug market and fend off competition from both parties. Eli Lilly and a wave of composite alternatives. These knockoffs have proliferated because of a regulatory loophole that allows companies like Hims to sell compounded versions of patent-protected drugs when brand-name treatments fall short.

Semaglutide, the active ingredient in Novo’s pill and blockbuster injections, is no longer in short supply in the United States, thanks to the company’s efforts to expand its manufacturing capacity. No shortages have been reported for the Wegovy pill, which has experienced a huge boom since it entered the US market in early January.

Even so, Novo estimated in January that as many as 1.5 million Americans were using compounded GLP-1 drugs.

Hims said the compound pill and other GLP-1 products contain semaglutide, even though the ingredient is protected by U.S. patents until 2032. His versions of these are legal because they are “personalized” in terms of dosage, Hims said.

But Novo said it did not directly or indirectly sell semaglutide to imitators and accused Hims of participating in illegal mass compounding activities.

Hims are “mass-marketed unapproved knock-off versions” [Wegovy and Ozempic] Evading the FDA’s gold standard review process — which is dangerous and misleading to patients and undermines the scientific innovation and regulatory rigor applied to ensure these treatments are safe and effective,” John Kuckelman, Novo’s general counsel and senior vice president of global law, intellectual property and safety, said in a statement.

On Friday, the Food and Drug Administration announced plans to take legal action against Hims for the pill; This includes restricting access to content and referring the company to the Ministry of Justice for possible violations.

Novo and Lilly have taken aggressive action against pharmacy compounding in the past two years as they capitalize on the growing popularity of weight-loss and diabetes drugs. Lilly went through a similar regulatory process for tirzepatide, the active ingredient in weight-loss drug Zepbound and diabetes treatment Mounjaro, which is no longer in short supply in the United States.