The fight between Novo Nordisk $NVO ( ▲ 4.41% ) and Hims & Hers $HIMS ( ▼ 17.98% )
just escalated from war of words to courtroom battle. Novo said it has filed a lawsuit accusing Hims of infringing a key patent covering semaglutide, the active ingredient behind blockbuster weight-loss and diabetes drugs like Ozempic and Wegovy.
Markets reacted fast. Hims shares plunged around 20% in premarket trading, while Novo climbed, reflecting investor bets that legal and regulatory risk is now front and center for the telehealth firm.
A Patent Fight With Big Stakes
Novo says the patent in question covers both oral and injectable semaglutide, meaning the lawsuit threatens not only Hims’ recently launched and discontinued pill version, but also the compounded injectable versions it continues to sell.
In a statement, Novo accused Hims of promoting compounded semaglutide products in ways that mislead consumers and healthcare professionals about the clinical benefits and safety of drugs that are not FDA-approved.
Hims fired back, calling the lawsuit an attack on Americans who rely on compounded medications for more affordable, personalized care. The company framed the case as Big Pharma trying to limit consumer choice through the legal system.
Regulators Turn Up the Heat
The legal action comes as federal scrutiny intensifies. The U.S. Food and Drug Administration recently signaled it would take swift action against companies mass-marketing “illegal copycat drugs,” comments widely interpreted as aimed at firms like Hims.
Soon after, the top lawyer at the Department of Health and Human Services said Hims had been referred to the Department of Justice for a potential investigation into violations of federal drug laws. It is still unclear if or when the DOJ might act, but the referral adds another layer of risk.
Notably, Hims discontinued its oral semaglutide pill shortly after those warnings, though it continues selling compounded injectable versions.
A Long-Running Battle Comes to a Head
Hims and other telehealth platforms began offering copies of Novo’s injectable weight-loss drugs during a period of shortages. Even after supplies improved, Hims continued selling versions it says are personalized for patients, leaning on a compounding loophole that Novo has repeatedly criticized.
Novo has tried multiple strategies, from cutting cash-pay prices to partnering with telehealth firms, including Hims for a time. That relationship ended last year after Hims kept selling compounded versions of Novo’s drugs.
With a patent lawsuit now in play and regulators circling, the dispute has shifted from a pricing and access debate to a high-stakes legal and regulatory showdown that could reshape how telehealth companies operate in the booming weight-loss drug market.