- US drugmaker Novo Nordisk sued Hims & Hers for selling unapproved weight-loss drugs
- Novo Nordisk warns of high impurity levels in Hims’ injectable and oral formulations
- FDA and medical bodies advise against unapproved compounded GLP-1 drugs for safety reasons
US drugmaker Novo Nordisk has filed a lawsuit against telehealth company Hims & Hers, accusing it of illegally selling unapproved versions of its blockbuster weight-loss and diabetes medicines Wegovy and Ozempic, and putting patients' health at risk.
The lawsuit, filed in the US, alleges that Hims infringed Novo Nordisk's patent by mass marketing compounded semaglutide products that have not been cleared by the US Food and Drug Administration (FDA). Novo Nordisk is seeking a permanent ban on the sale of these products and monetary damages.
The dispute is centred on semaglutide, the active ingredient in Wegovy and Ozempic, which has surged in demand amid rising obesity rates. Novo Nordisk claims Hims promoted compounded versions as safe and effective alternatives, despite the lack of regulatory approval.
"Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA's gold standard review process," said John F. Kuckelman, Novo Nordisk's senior vice president and general counsel. "That's dangerous and deceptive to patients."
He accused Hims of bypassing established safeguards, saying the company was "mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA's gold standard review process".
Kuckelman added that the company's legal action was aimed not just at protecting its patents, but at safeguarding public health. "We've taken legal action to protect the American public and our intellectual property," he said, adding that Novo Nordisk would continue to engage with regulators and law enforcement to ensure patients have access to FDA-approved medicines.
According to Novo Nordisk, testing of compounded semaglutide products revealed impurity levels as high as 86 per cent in injectable versions and up to 75 per cent in oral formulations. The company warned that such impurities could trigger severe immune reactions, overdoses, drug interactions and even hospitalisation.
The lawsuit also points to Hims' recently launched and abruptly discontinued-"Compounded GLP-1 Pill", which was rolled out shortly after Novo Nordisk introduced what it says is the first FDA-approved GLP-1 pill for weight loss.
Regulators have also raised concerns. Last week, the FDA said that compounded GLP-1 drugs being mass marketed by telehealth platforms and pharmacies are products for which the agency "cannot verify quality, safety, or efficacy". Medical bodies such as the American Diabetes Association and the Endocrine Society have advised against the use of such knock-off drugs, citing safety and quality uncertainties.
Compounded drugs are typically permitted only when FDA-approved medicines are unavailable or unsuitable for specific patients. Novo Nordisk argues that with nationwide availability of Wegovy and Ozempic in the US, there is no justification for the widespread sale of compounded alternatives.
The case underscores growing tensions between traditional pharmaceutical companies and telehealth firms that have moved aggressively into the booming weight-loss drug market, often offering cheaper or more accessible options. It also raises broader questions around regulation, patient safety, and the limits of compounding amid soaring demand for GLP-1 medications.
Novo Nordisk said it would continue to work with regulators and law enforcement agencies to curb what it describes as the illegal sale of unapproved semaglutide products.
Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.
