Cheap, Copycat Ozempic Was Supposed to Go Away. It’s Still Everywhere.

The copycat weight-loss drugs party was supposed to be over, but it’s still raging on.

Because of shortages of the name-brand medications — Ozempic or Wegovy for semaglutide and Zepbound or Mounjaro for tirzepatide — the FDA allowed a flood of providers to jump into the market over the past few years with cheaper, off-brand versions called compounded drugs. The FDA declared the scarcities resolved over the past year, so if people wanted to keep taking the GLP-1s, they would need to switch to the patented versions. Many patients were not thrilled with this, given the eye-watering price tags on the official stuff, but the law appeared to clearly state that once the drugs were no longer in short supply, the pharmacies making the dupes had to stop.

Now the law seems a little less clear — or at least different interpretations of it are pushing into more gray areas. While platforms such as Ro and Weight Watchers have stopped selling and advertising compounded GLP-1s, others, such as the direct-to-consumer telehealth company Hims & Hers, have kept on keeping on. Compounders say they have found loopholes that mean they can continue to sell copycat weight-loss drugs, despite warnings from the FDA about safety and legal threats from drugmakers Eli Lilly and Novo Nordisk. Novo Nordisk has estimated that about 1 million patients in the US are still on compounded GLP-1s.

The state of affairs epitomizes a lot of what’s wrong with the American healthcare system: Drugmakers have stumbled upon a miracle drug, but because of patents and drug pricing, many Americans aren’t able to access it. People, understandably, are willing to push the limits to get their hands on them, and market players have seized the financial opportunity to meet that need, even amid potential legal and medical risks. After all, what good is a miracle if it’s out of reach?

To provide some brief historical context, the brand-name versions of semaglutide and tirzepatide were so popular when they hit the US market in 2018 and 2022, respectively, that manufacturers were unable to keep up with demand. People were complaining that diabetes patients were losing access to Ozempic because people who were being prescribed Wegovy for weight loss were gobbling up the supply. (They’re the exact same drug, just with different names for their different prescribing purposes.)

I thought they were going to go away in the spring for the most part.

In 2022, the FDA put the drugs on its shortage list, which allowed compounding pharmacies — specialized pharmacies that prepare custom medications — to create their own versions of the injectable drugs. These formulations themselves weren’t FDA-approved, but the law allows FDA-regulated pharmacies to make them in certain instances, including shortages or to meet specific patient needs. Given how popular the drugs were, many companies were eager to jump on the opportunity to get into the GLP-1 business.

Once the drugs were pulled off the shortage list, which tirzepatide was in late 2024 and semaglutide was in early 2025, the compounders were supposed to halt production, since the law states it’s illegal for them to create what are “essentially” a copy of a commercially available, FDA-approved drug.

“I thought they were going to go away in the spring for the most part,” says Gina Moore, a senior associate dean at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences.

But some direct-to-consumer companies and pharmacies say they’ve found a workaround: “personalization.” These compounders add an ingredient to the drug formula — for example, vitamins B6 or B12, saying it may help alleviate nausea associated with GLP1s — or modify the dosage amounts. This allows them to argue that the drugs they’re prescribing and distributing are a special formulation dictated by a doctor or prescriber. This is broadly aligned with the purpose of compounding pharmacies: They make medications for people with unique needs that necessitate a special formulation. The Food, Drug, and Cosmetic Act, which outlines much of how the FDA is intended to regulate, allows personalized compounding, for example, so that a patient with a dye allergy or who has trouble swallowing can get the medication they need. But the small tweaks to the GLP-1s are stretching the limits on “personalization,” says John Hertig, a healthcare consultant, since some pharmacies may be distributing the same “personalized” version “on a mass scale, which doesn’t really then meet the definition of personalization, does it?”

“It’s not meant to take tirzepatide and then add B12 and say, ‘Oh, this is different just for you. And also we’re going to do it in thousands and thousands and thousands of doses with prearranged telehealth relationships with physicians who are just prescribing this nonstop,'” Hertig says.

To see just how easy it still is to access these compounded weight-loss drugs, I went to a telehealth company website, input some random information about my height, weight, and health, and was prescribed a GLP-1 without ever speaking to a doctor. That does not feel very personal to me. There are pharmacies, companies, lawyers, lobbyists who say that qualifies as coloring within the lines — medical appointments where patients and doctors don’t meet live are possible in the age of telehealth, and just because you have the same needs as other people, doesn’t mean the drug isn’t “personalized.”

“A lot of these sites, you fill out the questionnaire, then the prescriber looks at the questionnaire and then makes a determination whether they want to prescribe the drug. There is a prescription somewhere, you’re just not seeing it,” says Martha Rumore, an attorney at the Health Law Alliance, a group of healthcare defense lawyers. “The prescriber has to indicate on the prescription what the medical necessity is.”

The FDA has issued warnings about the potential risks of using non-FDA-approved compounded GLP-1s, before and after ending the shortage. This month, the FDA sent a warning letter to Hims & Hers regarding claims it makes on its website about its compounded semaglutide that it alleges imply the company’s products are the same as an FDA-approved product when they are not. It was part of a larger crackdown on deceptive advertising by direct-to-consumer pharmaceutical companies by the FDA, though some experts I spoke with say the regulator could do more.

“With the current presidential administration, they’re deferring more to the patient-doctor relationship and not challenging that and having that come into question as much as perhaps other administrations,” Moore says.

In an email to Business Insider, a Health and Human Services spokesperson noted that compounded drugs are not FDA-approved, meaning the agency “does not review compounded drugs for safety, effectiveness, or quality before they are marketed” and therefore recommends FDA-approved drugs where available and safe for the patient. The spokesperson added they’ve gotten reports about patients making mistakes with dosing or being prescribed extra-large or extra-frequent doses of GLP1s and said that healthcare providers “should be vigilant” when prescribing compounded weight-loss medications.

Technically, price is not supposed to be a factor in whether or not a compounded drug is dispensed, but it’s an unavoidable factor right now.

Some states have taken action on GLP-1 compounding. Ohio, for instance, has cracked down on medspas dispensing the drugs and is limiting the drug batch sizes pharmacies are allowed to produce, which could hit Hims & Hers. Drugmakers Eli Lilly and Novo Nordisk have also tried to take legal action to keep compounders at bay.

In a statement to Business Insider, a Hims & Hers spokesperson said that “one-size-fits-all care is outdated.” They added that the company follows “carefully written compounding regulations” and only offers access to medications when a licensed provider independently decides it’s necessary for a patient. Regarding the FDA’s letter and actions out of Ohio, the spokesperson said that Hims & Hers appreciates the FDA’s efforts “to make sure health information is accessible in a way that helps consumers make informed choices,” touted the company’s “industry-leading facilities,” and noted it has a track record of working with regulators.

The story around GLP-1s is as much about money as it is about health. The name-brand medications are expensive, and often not covered by insurance, so people turn to more affordable, accessible versions. Some patients would also be turned down by their doctors or insurance companies for brand-name drugs, so they turn to compounding companies that are often more lax with prescribing.

“Technically, price is not supposed to be a factor in whether or not a compounded drug is dispensed, but it’s an unavoidable factor right now,” says Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, an industry group. “Prescribers are sitting down with Mrs. Jones and Mrs. Jones who said, ‘I want some of this stuff to manage my weight or manage my diabetes, but I can’t afford that FDA-approved drug.’ And I believe prescribers are sympathetic.”

Manufacturers have brought the costs of the brand-name drugs down, in part, to fend off the compounders. Eli Lilly offers self-pay options for Zepbound for as low as $349 for the smaller starter dose and $499 for the higher doses in vials, compared to only price options of over $1,000 a month when it was first released. Novo Nordisk has a $499 option for its drugs, a discount from the original roughly $1,000 price. It’s still more expensive than the compounded versions — Hims & Hers, for example, sells semaglutide starting at $199 a month — but it’s getting closer.

“The lower-priced compounded drug is actually serving to drive down the price of the FDA-approved drug,” Brunner says.

Patients may already be deciding that paying a couple of hundred dollars extra each month to get FDA-approved medications is worth it. If pricing comes down further, pharmacies and companies selling compounded versions will be squeezed more.

“If we see the branded manufacturers drop price, these compounders will have to cut prices to a hundred bucks or whatever that compelling level is to maintain their value proposition to patients paying out of pocket,” says Brian Tanquilut, a senior equity research analyst at Jefferies.

It’s also worth noting that compounded semaglutide is generally more widely available than compounded tirzepatide — Hims & Hers, for example, only sells the former. Tanquilut says that’s because tirzepatide is viewed as a “cleaner” drug with fewer side effects, so there’s less need for added “personalized” ingredients in theory. He also points out that Novo Nordisk’s US patent on semaglutide runs out in 2031, while Eli Lilly’s expires in 2036. Some companies may make the calculation that even if Novo Nordisk were to sue, the resulting legal battle would last until they could make generics anyway.

Semaglutide is also a more recognizable name than tirzepatide, even though the latter is more effective. Eli Lilly came out with a cheaper consumer offering for its medication before Novo Nordisk did, which may have discouraged some compounders from trying to get into the game.

The arrival of super-effective weight-loss drugs to the market has opened up a financial, medical, and regulatory can of worms. A lot of parties stand to make a lot of money — drugmakers, compounders, telehealth operations, etc. — and so there is a lot of effort to figure out, say, creative interpretations of the laws. And for patients, it’s understandable to want a relatively easy solution to weight loss, especially when other avenues have failed, and to want it at a price that won’t mean big sacrifices in other parts of their lives or breaking the bank. The best hope is that eventually, the name-brand formulations will become inexpensive enough that affordability and access won’t be as much of an issue, and that, even more eventually, generics will become available once patents expire.

But that’s the problem with much of the American healthcare system — there are a lot of hopes and eventuallys in the mix, and in the meantime, patients are caught in the expensive and confusing crosshairs.

Emily Stewart is a senior correspondent at Business Insider, writing about business and the economy.