Eli Lilly is suing four telemedicine companies selling compounded versions of its blockbuster obesity drug Zepbound and its diabetes treatment Mounjaro, escalating its battle against unauthorized sellers, manufacturers and distributors of copycat versions of the medicine.
In lawsuits filed Wednesday in the U.S. District Court for the Northern District of California, Lilly accused the sites — Mochi Health, Fella Health, Willow Health and Henry Meds — of deceiving consumers about “untested, unapproved drugs.”
Lilly also alleged some of the sites are selling versions of the drugs that haven’t been studied, such as oral tablets and drops.
For instance, Henry Meds sells what it claims is an oral version of tirzepatide, the active ingredient in Lilly’s drugs.
But Lilly in the lawsuit argued the oral version “is an untested knockoff that exposes patients to safety risks” because no clinical study has found tirzepatide taken orally is safe and effective.
“Lilly’s tirzepatide medicines are only tested and approved for under-the-skin injections— not for administration in any oral form,” the company wrote.
In a new approach, Lilly also accused Mochi and Fella of engaging in the corporate practice of medicine. The lawsuit claims neither company is owned by a physician, and that the telehealth companies exert influence and control over their supposedly “independent” affiliated medical groups.
Fella Health, which also operates a brand called Delilah for women, is affiliated with Fella Medical Group, while Mochi Health is affiliated with Mochi Medical, according to the lawsuits.
In its filing, Lilly claimed Mochi CEO Myra Ahmad is not a licensed physician
“Mochi Health and its unlicensed owners exercise undue influence and control over, among other things, the prescribing decisions of physicians at Mochi Medical—and, as a result, engage in, and aid and abet, the unlawful corporate practice of medicine,” Lilly said in its complaint against Mochi.
In its complaint against Fella Health, Lilly said the company made “sweeping corporate decisions that dictate patient care, such as when Fella changed patients en masse from one tirzepatide formulation to another with additives.”
Compounders had been allowed to produce and sell hundreds of thousands of their own versions of popular anti-obesity drugs, so long as the FDA considered them in shortage.
Compounded drugs are sold at vastly lower prices than the branded versions, but drug companies and some obesity specialists have expressed concerns that compounded products aren’t safe because they are not FDA-approved.
Lilly’s diabetes drug Mounjaro went into short supply in late 2022, though the FDA has since declared the shortage over, meaning mass compounding was supposed to stop.
But some compounders have argued they can continue marketing the drugs if they are administered in nonstandard doses, and if the compounded drugs are prescribed by a health care provider to meet a clinical need.
Lilly argued that Fella and Mochi Fella “unilaterally” changed the prescriptions for compounded tirzepatide. Fella allegedly required patients to take doses manipulated with additives, while Mochi changed from doses similar to Lilly’s to lower doses “that have never been studied.”
