Compounding Pharmacies To Stop Making Ozempic, Zepound Knockoffs: What To Know

People who rely on compounded GLP-1 drugs say they might not be able to afford brand-name versions, which are often not covered by insurance. Iuliia Burmistrova/Getty Images

• The FDA has ordered compounding pharmacies to stop making less expensive versions of popular weight loss medications like Ozempic and Zepbound.
• The order comes after federal officials determined there was no longer a shortage of GLP-1 drugs.
• People who rely on compounded medications say they may have to stop taking the drugs because the brand-name versions are too expensive.

A ban on so-called copycat versions of weight loss drugs that contain the active ingredient trizepatide took effect on March 19.

A similar prohibition on copycat weight loss medications that contain the active ingredient semaglutide is scheduled to take effect as early as April 22.

The bans follow the Food and Drug Administration’s updated guidance for compounding pharmacies manufacturing less expensive versions of Eli Lilly’s weight-loss medications Zepbound and Mounjaro as well as Novo Nordisk’s Ozempic and Wegovy.

The FDA announced the updated guidance after a federal judge ruled against the Outsourcing Facilities Association (OFA), which had filed a lawsuit on behalf of compounding pharmacies selling copycat trizepatide medications.

A similar lawsuit is being considered on behalf of pharmacies that produce the less expensive versions of semaglutide drugs.

Compounded drugs are not approved by the FDA, so the agency does not verify their safety, effectiveness, or quality. However, they can be sold under certain circumstances.

Telehealth providers such as Eden, Mochi, Ro, and Hims & Hers have been allowed to sell alternative versions of drugs since December 2022 due to a shortage of weight-loss drugs caused by increased demand for the products.

However, in December 2024, FDA officials announced that the medication shortage had ended. They ordered a transition period for compounding pharmacies to stop manufacturing the drugs, which are still protected by patents, and give Eli Lilly and Novo Nordisk exclusive rights to their products.

People who take these less expensive medications are concerned about losing a product that has helped them lose weight. They say they now have to decide whether to pay significantly more for a brand-name medication or stop taking GLP-1 drugs and risk regaining the weight they’ve lost.

Experts say the FDA decision could result in people being denied an important medical tool.

“The reason there is so much demand is because at this time these drugs are the most effective medications for weight loss,” said Mir Ali, MD, a general surgeon, bariatric surgeon, and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA.

What will happen to weight-loss drug supply?

A big question is whether Eli Lilly and Novo Nordisk will be able to produce enough of their GLP-1 medications to meet demand if compounding pharmacies cease manufacturing the drugs.

There’s also the question of whether prices for Ozempic, Zepbound, Wegovy, and Mounjaro will rise without the competition of copy cat medications.

Officials at Eli Lilly and Novo Nordisk did not respond to Healthline’s request for comment on this article.

Companies that sell compounded weight loss drugs vowed to continue to help their customers.

“We will continue to work to ensure that our patients can access the best treatments for their individual needs and goals, and follow applicable FDA rules and regulations on compounding,” said a statement provided to Healthline by Ro officials.

 “GLP-1s are helping millions of Americans improve their health. Continued access to safe, affordable, and consistently available treatment options are critical as we fight against obesity, which impacts over 40% of Americans,” added a statement sent to Healthline by officials at Hims & Hers, which, like Ro, sells a compounded semaglutide product.

Officials at Hims & Hers have released a new report stating that a shortage of GLP-1 drugs still exists in the United States.

Nonetheless, Ali said he expects that Eli Lilly and Novo Nordisk will be able to manufacture enough of their weight loss drugs to meet the demand.

People rely on compounded GLP-1s for affordability

Ali said he doesn’t expect the price on brand-name GLP-1 drugs to increase significantly because of the pressure on these companies to make the medications relatively affordable.

However, he said even if there is enough supply and the price doesn’t increase, that doesn’t mean people can afford them.

“Even if the medications are available, health insurance companies don’t cover these medications for a lot of people,” Ali told Healthline.

He added he is also concerned that consumers might purchase less expensive weight loss drugs in markets outside the U.S. Those products, he said, can be of dubious quality and sometimes even dangerous.

“People might not get what they pay for,” Ali said.

He noted that some people might be eligible for gastric bypass surgery as an alternative to losing weight without using drugs.

Minnesota resident Bailey Fields, 27, has polycystic ovarian syndrome (PCOS), a condition that, among other things, can lead to weight gain and potentially type 2 diabetes.

Fields told Healthline her current semaglutide medication from Hims & Hers costs $199 per month compared to the $675 per month she spent previously on Mounjaro.

Because she has PCOS and is at risk for diabetes, Fields’ doctor prescribed Mounjaro. Despite this, Fields noted her health insurance company would only cover the cost of a weight loss drug treatment if she were to develop type 2 diabetes.

Fields intends to maintain her weight but she is concerned she won’t be able to do that if she can no longer purchase the copy cat semaglutide product.

“I don’t know what will happen if I stop taking it,” she said.

Fields is not alone. Tennessee resident Todd Kennedy, 45, relies on compounded semaglutide for weight maintenance and hopes to lose more weight. He’s concerned the ban on compounded semaglutide may endanger that goal.

Kennedy now pays $165 per month for the Hims & Hers product. He said a brand-name version of the same drug would cost him $1,500 per month. He told Healthline he simply can’t afford the more expensive versions and called the FDA decision “short-sighted.”

“It gives people a tool,” Kennedy said. “I feel that taking away a valuable and effective tool isn’t benefitting anybody.”

How GLP-1s like Ozempic, Zepbound aid weight loss

Wegovy and Zepbound have been approved by the FDA as a weight loss treatment.

Ozempic and Mounjaro are FDA-approved as a treatment for type 2 diabetes. Ozempic is frequently prescribed off-label for weight loss, however.

These products work by either targeting the brain or affecting certain hormones to suppress appetite and make a person feel less hungry.

People prescribed the medications are also usually put on a specific diet and exercise routine.

Ali said these drugs are effective because they focus on the source of weight-loss issues.

“By treating the source, they are more likely to produce success,” he said.

Ali noted that the drugs are part of a new strategy in the medical field for treating people with weight management issues.

“There is a slow shift on looking at obesity as a chronic disease and the fact that it needs to be treated that way,” he said.