Compounded Versions of Mounjaro Being Sold at Pharmacies and Spas Prompt Lawsuits

After Novo Nordisk served legal notices to companies making compounded versions of its GLP- diabetes and weight loss blockbuster Ozempic (semaglutide), Eli Lilly has followed suit with its own lawsuits to protect its Ozempic rival Mounjaro.

Lilly is suing eight companies, accusing them of making and selling compounded versions of its diabetes drug Mounjaro (tirzepatide).

In a statement, Lilly said it filed the lawsuits to protect patients. The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.”

Among the companies Lilly has accused of selling non-US Food and Drug Administration (FDA) approved compounded products “fraudulently claiming to be Mounjaro” are medical spas, wellness centers and compounding pharmacies.

Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes. However, like Ozempic, it also has weight loss effects, which has prompted many people to seek it off-label, resulting in some controversy and exacerbating shortages of the drugs.

In July, Novo Nordisk filed lawsuits against several companies for producing and selling unapproved compounded forms of its semaglutide drugs Ozempic and Wegovy.

Related: Novo Nordisk Sues Makers of Wegovy and Ozempic Dupes

The eight companies that Lilly is going after over the compounded versions of Mounjaro include compounding pharmacies ReviveRx of Texas and Florida-based Better Life Pharmacy, Rxcompoundstore.com and Wells Pharmacy Network. The other four companies are Renew Medspa in Minnesota, Revival Aesthetics and Wellness in Utah, Graze Anatomy & Associates in Texas and Georgia Weight Loss & Aesthetics.

“These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” said Lilly in its statement.

In complaints against companies like Renew Medspa, Lilly said the company directly advertises Mounjaro on its website even though Lilly “does not provide the drug to the defendant for resale or distribution.” On Renew’s website, the company offers a “Tirzepatide Weight Loss Program” that includes shipping of the medication to participants’ homes.

“Defendants use Lilly’s trademark to attract customers and generate revenues and profits, including by passing off as ‘Mounjaro’ their own unapproved compounded drugs purporting to contain tirzepatide, and doing so for a use for which Mounjaro is not approved, namely weight loss,” Lilly said in the lawsuits.

Lilly explained that it is the only one that manufactures and commercially sells Mounjaro, and that it is available only in prefilled single-dose pens.

Lilly is seeking undisclosed damages in the lawsuits.

Since the compounded versions of Mounjaro are not FDA approved, Lilly said they may expose patients to potentially serious health risks.

The FDA issued its own warnings back in May about potential adverse events associated with the use of non-FDA-approved counterfeits of Ozempic and Wegovy. The agency said it had received reports of adverse events after individuals used compounded versions of semaglutide.

The agency said that some of the compounded versions of the drugs have been found to have salt forms of the drugs’ active ingredient semaglutide, which have not been fully assessed by the FDA.

Since compounded drugs are not approved by the FDA, the agency says it does not verify their safety, effectiveness or quality before they are marketed. It says people should not use a compounded version of the drug if the original is available.

In situations when a drug is not available, such as when the original drug is on its drug shortages list, which Mounjaro currently is on, the FDA says compounded drugs can be made and distributed with fewer restrictions.

The market for GLP-1-based weight loss drugs like Wegovy and Mounjaro (although Mounjaro is not approved for the indication) could reach $100 billion within the next ten years, according to industry analysts, and Lilly’s Mounjaro could account for half of the sales.