Did a $49 pill just set off a transatlantic pharma showdown? That’s the quick version. On Thursday Novo Nordisk — the Danish company behind Wegovy, one of the GLP‑1 drugs reshaping weight‑loss medicine — said it will pursue legal and regulatory action after telehealth provider Hims & Hers unveiled a much cheaper oral semaglutide pill it calls a personalized alternative to Wegovy.
Novo’s language was stark. In a public statement the company accused Hims of “illegal mass compounding” that jeopardizes patient safety and undermines the US drug‑approval system. Hims fired back that its product uses a different formulation and delivery system and that compounded medications are lawful when tailored for individual patients.
What was announced
Hims’ investor materials and press posts say the company will offer a compounded semaglutide pill for $49 for the first month and $99 thereafter under a multimonth plan. The telehealth firm argued the pill is a “personalized” compounded product — not a generic — and positioned it as an option for patients who prefer a pill to an injection. Hims has already been selling compounded semaglutide injectables and says the oral offering simply extends that portfolio.
Novo launched its branded Wegovy pill in the US in January and has emphasized that its product uses proprietary SNAC technology to boost oral absorption. Novo’s CEO recently said about 170,000 people were already taking the new pill. Semaglutide itself — the active ingredient in Ozempic and Wegovy — remains under patent protection in the US through 2032, a fact that sits at the heart of the dispute.
Why Novo is alarmed (and what it means)
From Novo’s perspective the issue isn’t just a lower price — it’s process and precedent. The company argues that mass compounding at scale circumvents the rigorous clinical, manufacturing and labeling standards that accompany FDA‑approved medicines. Novo says it will act to protect both patients and its intellectual property.
Hims counters that its approach is compliant with compounding rules and that it has modified formulations and delivery to justify the work. How similar a compounded pill can be — in absorption, bioavailability and dosing consistency — to a drug made with SNAC tech is a technical question that could shape legal and regulatory outcomes.
Investors reacted quickly. Shares of Novo Nordisk and rival Eli Lilly fell after Hims’ announcement, reflecting concerns that pricing pressure and copycat offerings could erode margins across the GLP‑1 market. Analysts point out that Novo’s 2026 guidance already predicted sales and profit declines amid intensifying US price pressure and looming loss of exclusivity in other markets.
The legal and regulatory tangle
Semaglutide patents give Novo strong legal ground in theory, but compounding statutes and FDA enforcement make this a more complicated battle than a straight patent suit. Novo’s complaint that Hims is engaging in "mass" compounding seeks to move the issue into both courtrooms and regulatory review.
This kind of fight over patents, manufacturing process and market access is increasingly familiar in tech and pharma — disputes over intellectual property frequently spill into long, high‑stakes contests. The U.S. Patent Office has recently shown willingness to re‑examine big IP claims in other industries, underlining how central patent questions can determine commercial outcomes a similar patent re‑examination process has played out in entertainment IP disputes.
Regulators, too, have previously scrutinized Hims. The FDA and other agencies have flagged deceptive advertising around GLP‑1 knockoffs in the past, and Novo has previously cut a short‑lived partnership with Hims after raising concerns about marketing practices.
What this means for patients and the market
For people seeking affordable weight‑loss treatments, a $49 introductory price is eye‑catching. But clinical experts caution that compounding raises questions about dose consistency and absorption — issues especially critical for oral semaglutide, where formulation matters for how much drug actually reaches the bloodstream. Novo points to its SNAC absorption technology as a differentiator; Hims says its pill is formulated differently and clinicians can personalize dosing.
Meanwhile, competitors such as Eli Lilly are racing toward their own oral GLP‑1 options (Lilly’s orforglipron is expected to seek FDA approval soon), meaning the market will see more pills, more pricing pressure and more legal skirmishes over how those products are made and marketed.
If this becomes litigation rather than negotiation, courts and regulators will be asked to weigh patents against compounding rules, patient access against manufacturing standards. And the outcome will ripple beyond these two companies, shaping how new drugs are priced, copied and distributed in a market already roiled by demand and affordability questions.
The next moves are likely to be procedural: filings, regulatory inquiries and, possibly, enforcement letters. Behind the motions, though, is a real tension — who gets to define an affordable pathway for patients when proprietary science, public need and aggressive direct‑to‑consumer playbooks collide? The answer will matter to drugmakers, telehealth startups and millions of people watching the GLP‑1 revolution unfold. For a closer look at how brand rights and platform disputes have played out elsewhere, consider how technology firms have navigated similar fights over content and identity in recent years in debates about brand rights and AI, for example.