Eli Lilly on Monday said it is lowering the cash prices of single-dose vials of its blockbuster weight loss drug Zepbound on its direct-to-consumer platform, LillyDirect, building on efforts by the company and the Trump administration to make the medicine more accessible.

The announcement also comes weeks after chief rival Novo Nordisk unveiled additional discounts on the cash prices of its obesity and diabetes drugs. 

Starting Monday, cash-paying patients with a valid prescription can get the starting dose of Zepbound vials for as low as $299 per month on LillyDirect, down from a previous price of $349 per month. They can also access the next dose, 5 milligrams, for $399 per month and all other doses for $449 per month, down from $499 per month across those sizes. 

Zepbound carries a list price of roughly $1,086 per month. That price point, and spotty insurance coverage for weight loss drugs in the U.S., have been significant barriers to access for some patients. 

Eli Lilly’s announcement comes just weeks after President Donald Trump inked deals with Eli Lilly and Novo Nordisk to make their GLP-1 drugs easier for Americans to get and afford. The agreements will cut the prices the government pays for the drugs, introduce Medicare coverage of obesity drugs for the first time for certain patients and offer discounted medicines on the government’s new direct-to-consumer website launching in January, TrumpRx. 

But Eli Lilly’s deal with Trump centers around lowering the prices of a different form of Zepbound – a multi-dose pen – after it wins Food and Drug Administration approval. 

That means Eli Lilly’s Monday announcement around cutting prices on the existing single-dose vials could allow more patients to get discounted treatments more quickly. 

“We will keep working to provide more options — expanding choices for delivery devices and creating new pathways for access — so more people can get the medicines they need,” said Ilya Yuffa, president of Lilly USA and global customer capabilities, in a statement. 

Eli Lilly’s stock, which has climbed more than 36% this year, fell nearly 2% on Monday. Its meteoric rise due to the success of Zepbound and its diabetes injection Mounjaro vaulted it to becoming the first health-care company to hit a $1 trillion market value last month. Though cutting prices means lower revenue per medication sold, Eli Lilly’s sales — and shares — have continued to soar through past pricing announcements as demand balloons.

With single-dose vials, patients need to use a syringe and needle to draw up the medicine and inject it into themselves. Eli Lilly first introduced that form of Zepbound in August 2024. 

It’s unclear how many patients are currently using single-dose vials of Zepbound. But Eli Lilly previously said that direct-to-consumer sales now account for more than a third of new prescriptions of Zepbound. 

Novo Nordisk earlier this month lowered the price of its obesity drug Wegovy and diabetes treatment Ozempic for existing cash-paying patients to $349 per month from $499 per month. That excludes the highest dose of Ozempic. 

The company also launched a temporary introductory offer, which will allow new cash-paying patients to access the two lowest doses of Wegovy and Ozempic for $199 per month for the first two months of treatment. 

Eli Lilly is suing two pharmacies for compounding Zepbound and Mounjaro, claiming the companies are skirting the Food and Drug Administration’s ban on the practice and luring people away from Lilly’s medicines.

In lawsuits filed Tuesday in Delaware and New Jersey, Lilly alleges the two companies — Strive Pharmacy and Empower Pharmacy — are falsely marketing their products as personalized versions of the drugs that have been clinically tested and are made using stringent safety standards. Lilly argues these claims are turning people toward compounded drugs and away from its FDA-approved treatments.

Empower in a statement said restricting access to personalized alternatives to commercial drugs is not in the best interest of patients, and it’s “committed to offering these life-changing formulations.” Strive called Lilly’s lawsuit a classic example of Big Pharma overstepping legitimate regulations to prioritize its own interests and said it will vigorously defend its position.

Compounding pharmacies and outsourcing facilities were largely supposed to stop making their own versions of tirzepatide, the active ingredient in Lilly’s weight-loss drug Zepbound and diabetes treatment Mounjaro, last month after the FDA determined the branded versions were no longer in shortage. Some continued compounding, tweaking the dosages and combining them with vitamins, distinctions that make them different from Lilly’s drugs and potentially allow them to skirt the FDA’s ban.

Lilly argues Strive and Empower are merely mass producing altered versions of tirzepatide rather than personalizing them. Branded drugs are allowed to be compounded at large scale when they’re in shortage. Outside of that, custom versions can be made for unique situations, like if a person is allergic to an ingredient or can’t take the form of the drug it’s normally sold in.

Strive and Empower supply tirzepatide to popular telehealth sites, including Lavender Sky Health and Mochi Health. In a statement, Mochi said it doesn’t anticipate any interruptions or delays in patient care as a result of this lawsuit, and that it remains confident in the integrity of its clinical approach. Lavender Sky Health didn’t respond to a request for comment.

We remain committed to providing safe, evidence-based treatments that prioritize their health and well-being above all else. We do not anticipate any interruptions or delays in patient care as a result of this lawsuit and remain confident in the integrity of our clinical approach.

These lawsuits will be the first test of Lilly’s ability to take on compounding pharmacies in court now that Zepbound and Mounjaro are off the FDA’s shortage list. And they could provide a roadmap for Novo Nordisk, whose obesity drug Wegovy and diabetes treatment Ozempic generally can’t be compounded after the end of May.

Medicare drug plans can now cover Eli Lilly‘s blockbuster obesity drug Zepbound for obstructive sleep apnea, CNBC confirmed on Wednesday. 

That opens the door for broader access to Zepbound, which is not currently covered by Medicare and many other insurance plans for weight loss. Demand for the injection has soared over the last year despite its roughly $1,000 per month price tag before insurance.

In a statement to CNBC, a spokesperson for the Centers for Medicare & Medicaid Services, an agency of the U.S. Department of Health and Human Services, said “current Medicare Part D and Medicaid coverage rules apply” to Zepbound following its landmark approval in December for the most common sleep-related breathing disorder.

Medicare Part D plans can only cover obesity drugs if they are used for an additional medically accepted purpose approved by the Food and Drug Administration, the CMS spokesperson said, referring to the agency’s guidance. The spokesperson added that Part D plans may consider using prior authorization — a process where a provider must first get approval from an insurer — for those drugs to ensure they are being used for that specific purpose. 

The FDA on Dec. 20 cleared Zepbound for patients with obesity and moderate-to-severe forms of obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. That made Zepbound the first drug treatment cleared for the estimated 20 million people with those forms of the disease, according to Eli Lilly.

In a statement on Thursday, Eli Lilly called Medicare’s coverage of Zepbound for the condition “good news.”

Medicare Part D plans are similarly allowed to cover Novo Nordisk‘s weight loss drug Wegovy for its other approved use: lowering cardiovascular risks. The diabetes counterparts of Wegovy and Zepbound — Ozempic and Mounjaro, respectively — are covered by Medicare and most insurance plans. 

Both Novo Nordisk and Eli Lilly are studying their weight loss medicines as treatments for fatty liver disease, chronic kidney disease, sleep apnea and more. To be covered, those drugs would need to return late-stage trial results and then be submitted for FDA approval for those uses.

Meanwhile, state Medicaid coverage for Zepbound and other obesity medications depends on what condition they are prescribed for and whether their manufacturer has signed a certain Medicaid drug rebate agreement, according to the spokesperson. 

Under that agreement with the secretary of Health and Human Services, manufacturers agree to provide rebates to states in exchange for Medicaid coverage of their drugs. States share the rebates with the federal government. 

A state Medicaid program must cover Zepbound if it is prescribed for OSA and Eli Lilly has signed the Medicaid drug rebate agreement, the spokesperson said. 

But if Zepbound is prescribed for weight loss, state Medicaid programs are not required to cover it. 

The Biden administration in November proposed a rule that would allow Medicare and Medicaid to cover weight loss drugs for patients with obesity. The rule would give millions of people access to weekly injectables, but it would cost taxpayers as much as $35 billion over the next decade.

It is unclear if President-elect Donald Trump’s administration will pursue the rule.

The roughly $1,000 monthly price tag of Eli Lilly‘s weight loss drug Zepbound put the blockbuster treatment out of reach for Willow Baillies, 29, whose insurance does not cover it.

Baillies, a human resources specialist based in Milwaukee, Wisconsin, has been attempting to lose weight and dealing with chronic autoimmune issues for years, so she turned to a cheaper alternative: a compounded, off-brand version of tirzepatide.

Tirzepatide is the active ingredient in Zepbound and in Eli Lilly’s diabetes counterpart Mounjaro, which are part of a class of highly popular medications called GLP-1s. 

She said compounded tirzepatide has helped change her life dramatically since she began taking it in June, alleviating pain from her autoimmune issues and helping her lose about 52 pounds. She said it costs her around $350 per month.

But soon, compounded versions of tirzepatide could become inaccessible to Baillies and other patients who rely on them. Patients and health-care experts said that could force some consumers to stockpile doses, switch to other treatments, or stop receiving care altogether due to financial constraints. Others could turn to a potentially unsafe method of mixing vials themselves. 

That’s because the Food and Drug Administration on Thursday announced that branded tirzepatide is no longer in short supply — a decision that will largely prevent compounding pharmacies from making and selling cheaper versions of the drug in the next two to three months. 

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient’s needs. 

The FDA’s decision, based on the agency’s comprehensive analysis of data, could mean that more patients with insurance coverage will be able to access Zepbound after months of limited supply. It also suggests that Eli Lilly’s multibillion-dollar effort to ramp up manufacturing for tirzepatide is starting to pay off. 

But it will also leave other patients in limbo, closing a niche, lucrative market for compounded tirzepatide that patients say helped fill a gap in care for those who can’t afford to pay out of pocket for Zepbound.

Many insurance plans still don’t cover drugs for weight loss, and some patients said prices under Eli Lilly’s savings program and for its half-priced vial versions are still too high.

“I’ve stockpiled 10 compounded vials at home, so I have at least a year’s worth,” said Baillies, one of six patients CNBC spoke with about compounded tirzepatide. “We’re willing to kind of do anything to have this. It’s not just about looks; it’s about the opportunity it gives us to live our lives to the fullest.” 

Many patients and major trade groups question whether the shortage is truly resolved amid reports of people still struggling to find Eli Lilly’s drugs. 

Some medical professionals raised concerns about whether Eli Lilly can meet demand once more patients come off compounded tirzepatide and others start Zepbound for its newly approved use: obstructive sleep apnea. 

It’s unclear how many people are on compounded tirzepatide, but one trade group estimated in November that there are more than 200,000 prescriptions for compounded versions of its main rival — Novo Nordisk‘s weight-loss drug Wegovy — being filled each month. 

“In this current moment, I have confidence that the shortage is over,” said Dr. Shauna Levy, an obesity medicine specialist and medical director of the Tulane Bariatric Center in New Orleans. “Do I think the shortage is over forever? Probably not.” 

Eli Lilly did not immediately respond to a request for comment.

In its decision announced Thursday, the FDA concluded based on data from Eli Lilly, patients, providers, compounders, and other sources that “Lilly’s supply is currently meeting or exceeding demand and that, based on our best judgment, it will meet or exceed projected demand.”

The FDA is giving so-called 503A compounding pharmacies until Feb. 18 before it takes enforcement action that would put a halt to their work. The 503A pharmacies make compounded drugs according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA. 

Meanwhile, pharmacies manufacturing compounded drugs in bulk with or without prescriptions — known as 503B outsourcing facilities — get an additional month, with a deadline of March 19. They are regulated by FDA guidelines. 

Those “off-ramp periods are appreciated” because it gives patients time to switch to brand-name tirzepatide, said Tenille Davis, chief advocacy officer for trade group Alliance for Pharmacy Compounding.

But the group’s members are still reporting that “there’s a real lack of availability” of tirzepatide, she said. That trade group represents compounding pharmacies and hybrid pharmacies that also dispense regular drug prescriptions.

Still, 503A pharmacies may be allowed to continue making compounded tirzepatide in certain situations under the law, Davis said. 

That includes when a prescriber determines that a compounded version with certain changes will produce a “significant difference” for a patient. For example, a patient may need a specialized dose or be allergic to the dye in a branded product. 

Davis said that means compounded tirzepatide won’t be completely eliminated in the U.S., but the scale of it will “certainly decrease.”

The legal battle between the FDA and the Outsourcing Facilities Association isn’t over yet, however. On Thursday, the FDA and OFA jointly said they will provide an update in court by Jan. 2 to address the “next steps in this litigation.” They also said if the trade group files a preliminary injunction over the next two weeks, the FDA will not take action against its members for continuing to make compounded tirzepatide until the court resolves the case.

That pending litigation further “adds to the confusion of the status of compounded tirzepatide after February and March,” said Dae Lee, a partner at law firm Frier Levitt who represents pharmacies, none of which were involved in the dispute with the FDA.

“If compounded semaglutide goes away as well, then I will be screwed,” Bonello said. She has launched an online petition demanding that the FDA support access to compounded GLP-1s. The petition has gained more than 15,000 signatures in the past month.

Another patient, Erin Hunt, 31, a communications analyst based in Maryland, said she may eventually switch to the branded version of tirzepatide. 

Hunt started taking compounded tirzepatide in April after struggling to find supply of Zepbound, which she took for one month. It has helped her lose around 55 pounds, experience fewer symptoms from her chronic inflammatory conditions and pursue a healthier diet and exercise. She said she initially paid $300 per month for the compound drug and now pays $350 for a higher dose.

Hunt’s insurance does not cover Zepbound. But she qualifies for Eli Lilly’s savings card program, which allows commercially insured patients without coverage for Zepbound to buy a month’s supply for around $650. Under that program, patients whose commercial insurance plan covers Zepbound can pay as low as $25. 

“I am extremely concerned for what it’s going to cost,” Hunt said. “This medication has literally changed my life, and it’s probably going to benefit me to be on a maintenance dose for life.”

For Jill Skala, 49, a teacher in western Pennsylvania, the FDA’s decision means that she will lose a more affordable option after her insurance drops Zepbound coverage on Jan. 1. 

Her copay for Zepbound has been around $10 per month since she started the drug in March. Skala said she has lost 52 pounds and noticed “profound improvements” in her mental health, sleep and energy levels. She has stockpiled a three-month supply of Zepbound, she said, and will “do the best I can to maintain my weight loss” once that runs out.

“I don’t see myself continuing to get the branded version at this point unless there’s a pathway back through insurance or Eli Lilly drops the price,” Skala said. “I just paid off my student loans. I don’t want to start my medical debt problem here.”

Other patients may turn to an underground community Reddit users call “the gray market”: People directly purchase powdered tirzepatide or semaglutide peptides for as little as $50 per month from certain vendors, including Chinese manufacturers, and mix that with sterile water at home, creating a solution they can inject under their skin. 

Reddit users say the community establishes protocols for third-party lab testing of peptides to verify their purity and promotes safe mixing and dosing practices. 

But Tulane’s Levy said the method “seems very dangerous,” noting that mixing homemade medications without proper training “could potentially have real consequences.” 

She said it “highlights people’s desperation to treat the disease of obesity, which is being inadequately met by our current insurance status” for drugs such as Zepbound. 

Some compounding pharmacies such as Strive Pharmacy are operating as usual pending more updates to the legal fight. Strive operates nine 503A pharmacies across the U.S., which offer compounded GLP-1s and other services. 

But Strive will largely stop making compounded tirzepatide by the February deadline if nothing further happens, according to Matthew Montes de Oca, the company’s chief clinical officer. He acknowledged that Strive could create compounded versions of the drug for specific prescriptions, such as adding glycine to help prevent muscle deterioration in a patient. 

Compounded tirzepatide with glycine is what Gina Wright’s doctor will prescribe for her so she can continue taking the unbranded version, which she gets from a different pharmacy. Wright, 58, a self-employed business consultant in Colorado who is prediabetic, said she is paying $225 for a five-milligram dose, which she began taking earlier this month. 

She is on her state Medicaid plan, which does not cover Zepbound, so she does not qualify for Eli Lilly’s savings card program. But Wright said she also has sleep apnea, so she is trying to get insurance to cover Zepbound for that purpose.

De Oca said compounding individual prescriptions for specific patients will make it harder for Strive to ensure that all of its safety procedures are still in place. Strive typically tests its tirzepatide and semaglutide with a third-party analytical company and conducts a months-long “stability study” to guarantee the quality and safety of the product before creating batches of up to 250 vials, he noted. 

Dr. Mace Scott, the owner and medical director of Chronos Body Health Wellness, said the fate of compounded tirzepatide at his Louisiana-based medical spa will depend on the pharmacies he sources it from and “how they decide to move forward.” His spa relies on both 503A and 503B pharmacies, he said, so some patients may be able to continue compounded tirzepatide with a specialized prescription. 

Scott said he is trying to help some patients get insurance approval for branded tirzepatide. He is recommending that others switch to compounded semaglutide, which is what roughly 75% of Chronos patients are taking, he said. The spa has treated more than 10,000 patients with branded or compounded GLP-1 medications, according to its website.

“It’s kind of a tough road to traverse right now, so we’re trying to figure out what’s best on a patient-by-patient basis,” Scott told CNBC. 

The American Diabetes Association, a nonprofit organization that promotes diabetes research and advocacy, told CNBC it recommends against the use of compounded GLP-1s due to “ongoing concerns” about their safety, quality and efficacy.

It is difficult to discern the quality of the product and its distributor, which poses a potential risk to patients, Joshua Neumiller, the association’s president-elect for health care and education, said in a statement.

Neumiller also pointed to an FDA alert in July about cases of patients measuring and administering incorrect doses of compounded GLP-1s, some of which resulted in adverse events that required hospitalization. 

But Molly B., an interior designer based in New York who asked CNBC to omit her full last name, said compounded GLP-1s are her only option.

She said her insurance denied coverage for brand-name semaglutide twice before she started taking compounded tirzepatide in September. It has helped her lose 23 pounds, she said, and eliminated constant thoughts about food — a game changer for a patient suffering from polycystic ovary syndrome, a hormonal disorder that makes it difficult to lose weight. 

“I have never been able to lose this much weight on my own, and I’ve tried 100 times,” she said. “This has really changed my life, so I would hope that I can continue to get it the way I am now.”

The Food and Drug Administration on Friday approved Eli Lilly‘s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding its use and possibly its insurance coverage in the U.S.

The weekly injection is now the first drug treatment option cleared for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity, the FDA noted in a release.

An estimated 80 million patients in the U.S. experience the disease, according to Eli Lilly. Roughly 20 million of those people have moderate-to-severe forms of the disease, but 85% of cases go undiagnosed, the company told CNBC earlier this year.

“Too often, OSA is brushed off as ‘just snoring’ — but it’s far more than that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders, in a release from Eli Lilly. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.” 

Eli Lilly expects to launch the drug for OSA at the beginning of next year. It is the first approval beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the U.S. market for longer as the diabetes drug Mounjaro.

The agency’s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans. That includes the federal Medicare program, which only covers obesity drugs if they are approved and prescribed for an added health benefit.

The approval also backs up mounting evidence that there could be further health benefits tied to GLP-1s, a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages over the past year. Notably, Zepbound’s main rival, the weight loss drug Wegovy from Novo Nordisk, is not approved for OSA.

Zepbound could be a valuable new treatment option for patients with OSA, which can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure. Patients with the condition have limited treatment options outside of wearing masks hooked up to cumbersome machines that provide positive airway pressure, or PAP, to allow for normal breathing.

Eli Lilly in April released initial results from the two clinical trials, which showed that Zepbound was more effective than a placebo at reducing the severity of OSA in patients with obesity after a year.

In June, Eli Lilly released additional data from the studies showing that Zepbound helped
resolve OSA in almost half of patients. The first study examined the weekly injection in adults with moderate-to-severe OSA and obesity who were not on PAP therapy. The second tested Zepbound in adults with the same conditions, but those participants were on and planned on continuing PAP therapy.

The data showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved “disease resolution,” according to the company. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.

Researchers came to those conclusions by examining an apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.

Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, the company said. It is also defined as a person having five to 14 AHI events per hour and scoring a certain number on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.

The Food and Drug Administration on Thursday said the active ingredient in Eli Lilly’s weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making cheaper, unbranded versions of the injection.

“FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved,” the agency said in a letter. “FDA continues to monitor supply and demand for these products.”

The agency’s decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations related to the treatment’s shortage status.

Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said that transition period will give patients time to switch to the branded version.

It’s a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes counterpart Mounjaro is.

It’s the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Eli Lilly’s diabetes treatment Mounjaro. Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand.

A trade organization representing compounding pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists. It also argued that the FDA’s action was a coup for Eli Lilly that came at the expense of patients.

Following the suit, the FDA said it would reevaluate removing tirzepatide from the shortages list. That allowed compounding pharmacies to continue making copycats while the agency reviewed its decision.

Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.

The U.S. Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are available. 

However, the FDA does inspect some outsourcing facilities that compound drugs, according to its website.

Patients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per month before insurance and other rebates. Many health plans don’t cover tirzepatide for weight loss, making compounded versions a more affordable alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. But the FDA earlier this month said all doses of those drugs are now available.

The agency has yet to announce whether it is removing semaglutide from its shortage list — a decision that would likely affect even more compounding pharmacies since it is more widely used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their drugs to outside groups. The companies say that raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have both stepped in to address illicit versions of their treatments, suing weight loss clinics, medical spas and compounding pharmacies across the U.S. over the past year. The FDA last month also said it had received reports of patients overdosing on compounded semaglutide due to dosing errors such as patients self-administering incorrect amounts of a treatment.