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An Ohio telehealth company called Hims and Hers Health introduced a compounded, $ 49 per month GLP-1 agonist pill to the market yesterday and chaos has reigned in the pharmaceutical space ever since:
Exclusive: Hims offers cheapest GLP-1 weight-loss pill in US in a shock to Novo, Lilly
By Amina Niasse - February 5, 2026Summary
- Hims and Hers Health will offer the drugs at a price $100 cheaper than the brand-name offerings
- Novo Nordisk shares fall to lowest level since 2021
- Novo says it is considering legal action
NEW YORK, Feb 5 (Reuters) - Online telehealth company Hims and Hers Health (HIMS.N) on Thursday began offering a much cheaper $49 compounded version of Novo Nordisk's (NOVOb.CO) new Wegovy weight-loss pill in a move that expands sales to many Americans but could undercut Novo's and Eli Lilly's (LLY.N) plans for the consumer market.
The news touched off a swift reaction on Wall Street as investors sold off Novo and Lilly shares, and the Danish drugmaker promised a legal challenge to the move by Hims. Novo shares fell 8.6%, while Lilly was off (LLY.N) 6%.
Hims' pricing, $49 for the first month and $99 afterwards for those who purchase a five-month plan, makes their GLP-1 drug as affordable as monthly internet or streaming services in the U.S. It can offer access to treatment for many more of the estimated 200 million Americans who are overweight or obese.
It is $100 less than Novo, which launched its pill in January at $149 for first-time users and $199 after that. Lilly is expected to launch its pill in April and has promised the Trump Administration affordable pricing including on its new TrumpRx site.
Hims' move came after Novo warned on Wednesday that pricing pressure was unprecedented for its weight-loss medicines and dropped its full-year forecast. Novo shares on Thursday hit their lowest level since July 2021.
NOVO SAYS ITS PILL IS UNIQUE
Novo CEO Mike Doustdar in a meeting with investors on Thursday said people spending $49 on a Hims' pill would be wasting their money and that Novo's pill uses unique technology that aids in the absorption of the medicine.
Novo spokeswoman Ambre James-Brown described Hims' mass compounding as illegal. "Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework," she said.
A Hims spokesperson said it has not compromised on safety or efficacy and that the company uses a technology based on liposomes that is intended to support absorption.
Analysts questioned if customers would get similar results on the cheaper pill but said it could drive a price war if compounders can provide an oral drug in large quantities.
Hims has been tussling with Novo since it was allowed in 2023 by the U.S. Food and Drug Administration to sell versions of Novo's GLP-1 injectible drugs while the branded medicines were in short supply. Since then, it has made "personalized" copies of the branded drugs at different doses or regimens than those available from Novo and other drug companies.
These drugs are not FDA approved and are subject to limited agency oversight. They also do not go through clinical trials to prove efficacy. Novo's Wegovy pill showed weight loss of more than 16% in trials.
"The status quo for months now has been a compounder can create a copycat version of a branded drug, so long as they make some kind of minor tweak that they believe or they argue benefits specific patient groups," said TD Cowen analyst Michael Nedelcovych.
HIMS MAKES CASE FOR MORE CHOICE
Hims said the treatment can be tailored for patients aiming to mitigate side effects or who prefer a pill over the injectable option. Semaglutide is the main ingredient in the new Wegovy pill as well as injectable Wegovy and Ozempic.
"We're excited to find ways to continue bringing branded treatments to the platform across specialties. More choice on the platform is the best thing for customers everywhere," said Hims CEO Andrew Dudum in a statement.
Novo and Hims had a partnership in 2025 allowing the telehealth company to offer injectable Wegovy, but the two companies walked away with Novo saying Hims had wrongfully marketed versions of its medicine. Dudum accused Novo of attempting to control how clinicians at Hims make decisions.
By tailoring its offering for patients with side effects or an aversion to needles, Gaston Kroub, a patent lawyer in New York, said Hims is positioning the oral product as another personalized option, widening the scope of personalization under the FDA’s framework.
"HIMS has shown a willingness to go as close to the line as possible,” he said. “It’s a strategy of saying, ‘All right, if we pop our head over the barbed wire fence, is anybody going to take a shot?’”
Novo launched the drug in the beginning of January and has seen strong demand in the U.S., where it is available on its cash-pay direct-to-consumer website.
Novo Chief Financial Officer Karsten Munk Knudsen told Reuters on Wednesday that the drugmaker is frustrated by continued mass marketing of compounded drugs, and said it was up to the U.S. regulator and politicians to address this.
The FDA in September issued a warning to Hims regarding its marketing of compounded semaglutide, stating claims like "same active ingredient as Ozempic and Wegovy" are misleading, as compounded drugs are not FDA-approved.
LILLY PILL IS NEXT UP
In addition to U.S. pricing pressure, Novo is girding for competition from Eli Lilly on the oral weight-loss front as the Indianapolis-based drugmaker expects to launch its own pill in the second quarter.
Some analysts said Lilly's pill, an experimental GLP-1, could be a next target for compounded copies. Compounding, in which pharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, has flourished as Americans chase cheaper prices for drugs.
Hims declined to comment on the drug. Lilly did not have an immediate comment.
In 2025, Hims doubled the size of its facility in New Albany, Ohio. The company said on Thursday the expansion allows Hims to provide treatments at a lower price.
In response to the Hims and Hers Health GLP-1 receptor agonist pill offering, FDA Commissioner Marty Makary says that the Food and Drug Administration will "take swift action" against companies mass-marketing illegal copycat drugs. Uppermost on his mind is undoubtedly the New England Compounding Center (NECC) in Framingham, Massachusetts whose contaminated injectable epidural steroids caused a fungal meningitis outbreak in 2012 which killed more than 64 people, including 11 here in Michigan:
Novo Nordisk shares rebound as FDA targets illegal drug copies
By Jacob Gronholt-Pedersen - February 6, 2026COPENHAGEN, Feb 6 (Reuters) - Shares in Danish drugmaker Novo Nordisk (NOVOb.CO) gained 5.4% on Friday, recovering some of the previous two sessions' steep losses, after the U.S. Food and Drug Administration (FDA) pledged to address mass-marketing of unapproved drugs.
The stock plunged nearly 8% on Thursday after telehealth company Hims and Hers Health (HIMS.N) launched a significantly cheaper $49 compounded version of Novo Nordisk's FDA-approved Wegovy weight-loss pill.
Novo's shares, which are near their lowest since Wegovy was introduced in June 2021, were 5.4% higher at 1341 GMT.
Late on Thursday, FDA Commissioner Marty Makary said on X that the agency would "take swift action" against companies mass-marketing illegal copycat drugs. "The FDA cannot verify the quality, safety or effectiveness of non-approved drugs," he said without naming any companies.
Despite the FDA statement, Bernstein analyst Christian Moore said he wasn't holding his breath for U.S. authorities to take decisive action.
"We do think people will still buy it, and don’t think the government will do anything to stop it, based on precedent," he said.
The FDA and individual states share regulatory authority over compounding pharmacies. In September, it launched a new tracker to show when ingredients were coming from FDA-inspected facilities. It also sent letters that month to companies it said were practicing deceptive direct-to-consumer advertising, including Hims, Novo, and rival Eli Lilly (LLY.N).
Novo, which on Wednesday flagged unprecedented price pressure that saw its stock plunge 17%, said on Thursday it would take "legal and regulatory action" in response to Hims' announcement but declined to elaborate further on Friday.
Eli Lilly, which is awaiting a U.S. regulatory decision on its weight-loss pill orforglipron, was also critical of the launch announcement.
"Patients deserve better than untested knockoffs that are sold without clinical evidence that they even work," a Lilly spokesperson said in an email to Reuters on Thursday before Makary's public post.A Hims spokesperson said on Thursday the company had not compromised on safety or efficacy and used a technology based on liposomes intended to support absorption, in response to similar criticisms from Novo.
Lilly's shares, which had ended the prior session down about 8%, rose 3.8% in premarket trading.
($1 = 6.3327 Danish crowns)
Hims & Hers Health folds:
https://x.com/HimsHersComms/status/2020207947645911214
PostHims & Hers Comms
@HimsHersCommsSince launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment. We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.
This may change in March, when Novo Nordisk's compound patent expires.
Novo Nordisk filed suit against Hims & Hers:
Novo Nordisk sues Hims & Hers over patent infringement
By Stine Jacobsen - February 9, 2026COPENHAGEN, Feb 9 (Reuters) - Novo Nordisk (NOVOb.CO), opens new tab said on Monday it has filed a lawsuit against U.S. telehealth company Hims & Hers (HIMS.N), opens new tab for infringing on the Danish group's patents.
"Novo Nordisk is asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages," the Danish drugmaker said in a statement.
The move comes after Hims on Saturday cancelled the launch of a $49 copy of a weight-loss pill from Novo Nordisk and the U.S. Food and Drug Administration.
The Hims and Hers' reply:
https://x.com/HimsHersComms/status/2020854864666923411
PostHims & Hers Comms
@HimsHersCommsNovo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice. This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer. Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access.
8:38 AM · February 9, 2026
Hims & Hers Health falls on its financial sword:
Hims & Hers forecasts first-quarter sales below estimates, shares fall
By Sneha S K in Bengaluru; Editing by Alan Barona - February 23, 2026Summary
- Shares fall 7% after hours
- Personalized weight-loss products generate $65 million headwind in Q1
- Overseas expansion to boost growth in non-weight-loss business
Feb 23 (Reuters) - Online telehealth company Hims & Hers Health (HIMS.N), which sells weight-loss drugs, hormone replacement therapies and health services, on Monday forecast first-quarter revenue below estimates, pushing its shares down 7% in after-hours trading.
The company said that the first quarter would be facing a $65 million burden from changes in the shipping of weight-loss products, which must be personalized for each prescription based on U.S. law.
Hims and Hers has grown rapidly as customers flocked to its cheap weight-loss drugs, which include compounded injectable versions of Novo Nordisk's highly popular Wegovy. Since those drugs are no longer in shortage, Hims is only allowed to make the medicines for customers if the dosage or ingredients are personalized.
Hims' efforts to launch compounded copies of Novo's new Wegovy pill at an introductory price of $49 per month were cut down earlier this month by the U.S. Food and Drug Administration, which said it would take action against it and other companies and referred Hims to the Department of Justice. Hims said in a regulatory filing that it is unclear what actions the regulators and DOJ may pursue. Novo also filed a patent suit against the company.
The stock is down 52% so far this year. Still, the company gave a 2026 outlook with the midpoint above analysts' estimates and vowed to stay on course.
"We plan to continue to operate like we always have," said CEO Andrew Dudum, who added the company is systematically broadening and diversifying its offerings. "It's important to remember that the majority of our revenue and profitability is driven by offerings outside of weight loss."
Hims and Hers forecast revenue of $600 million to $625 million for the first quarter, missing estimates of $653.11 million, according to data compiled by LSEG.
Hims also expects 2026 revenue to be in the range of $2.7 billion to $2.9 billion, compared to estimates of $2.74 billion.
REGULATORY RISK FUELS UNCERTAINTY
International expansion may help it grow but does not address the continuity of the company's weight-loss business, which remains uncertain due to regulatory risks, said Michael Cherny, an analyst at Leerink Partners.
"It would widen the long-term opportunity, but the more important component for the stock is how Hims progresses with its weight-loss business," Cherny said.
The company said its outlook gives "flexibility to lean into future investments" and said it will keep Hims on track for its 2030 target of more than $6.5 billion in revenue.
Hims last week said it will acquire Australian digital health company Eucalyptus in a deal valued at up to $1.15 billion. Analysts said the deal could accelerate growth for the company's non-weight-loss offerings.
Subscribers rose to 2.5 million, up 13% from the prior year.
It reported quarterly revenue of $617.8 million, an increase of 28% year-over-year, but below the analysts' average estimate of $619.22 million.
The company's product costs increased over 30%, a regulatory filing showed.
Hims' investment in its Super Bowl ad will also raise first-quarter operating costs, CFO Yemi Okupe said.
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