Lilly Threatens Obesity Drug Copycat Makers After Shortage (1)

Eli Lilly & Co. is targeting additional drug compounders and telehealth companies that make copycat versions of its weight loss drug, with plans Tuesday to file two lawsuits and send about 50 cease-and-desist letters.

The company is demanding that the compounders and telehealth companies stop mass producing its blockbuster drug tirzepatide—a diabetes and obesity treatment branded as Mounjaro and Zepbound.

Weight loss drugs dominate the compounding industry, filling market demand after brand manufacturers declared they were in shortage. The industry producing copycats is estimated to exceed $1 billion in annual sales.

Compounded tirzepatide can be purchased for a few hundred dollars, while Lilly’s list price for its injections typically costs around $1,000 a month. The company in February reduced the cost of its 2.5 milligram and 5 milligram Zepbound vials to $349 and $499 a month, ramping up the fight against cheaper, copycat versions of the drug.

The lawsuits, which are set to be filed in the US District Court for the District of Delaware and the US District Court for the District of New Jersey, claim that two compounding pharmacies offer custom-made, personalized tirzepatide products that haven’t been approved for safety and effectiveness. The challenges targeted Strive Pharmacy LLC and Empower Clinic Services LLC.

The compounding pharmacies say their products are customized for individual consumers and are better suited for patients, according to the lawsuits reviewed by Bloomberg Law.

The cease-and-desist letters emphasized the Food and Drug Administration’s declaration last year that Lilly’s tirzpeatide shortage is over, and therefore they cannot legally regularly compound the medicine. Lilly asks the compounders to confirm by April 8 that they ceased the manufacture, production, dispensing, promotion, and sale of all forms of compounded tirzepatide.

The company says they have now had approximately six months to help patients transition from compounded tirzepatide to FDA-approved medicines.

“There is zero clinical evidence supporting such manipulations, and the sale of these products remains both illegal and misleading to patients,” Lilly’s counsel wrote in a letter viewed by Bloomberg Law.

“For good reason: the risks associated with selling unapproved, untested, unregulated, mass-produced, compounded products can lead to catastrophic harm, especially for injectable products like tirzepatide that need to be sterile.”

The move ramps up Lilly’s legal campaign against compounded tirzpeatide, which includes various other lawsuits against telehealth companies and medical spas, along with hundreds of cease-and-desist letters.

The cases are: Eli Lilly and Company v. Strive Pharmacy LLC, D. Del., No. 1:25-cv-00401, complaint filed 4/1/25; Eli Lilly and Company v. Empower Clinic Services LLC, D.N.J., No. 2:25-cv-02183, complaint filed 4/1/25