In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
Eli Lilly has sued four telehealth providers for promoting and selling compounded versions of the pharma’s top-selling weight-loss drug tirzepatide.
The legal barrage comes months after the FDA in December 2024 affirmed that tirzepatide is no longer in shortage and formally barred compounders, who had legally been allowed to make the drug while it was in shortage, from producing and distributing knockoff versions, giving them until March 19 to comply. In an email to BioSpace, a Lilly spokesperson said that while many have ceased compounding, “some bad actors have not.”
“Indeed, some entities that continue selling compounded tirzepatide are unlawfully engaged in the ‘corporate practice of medicine,’” the spokesperson noted, referring to nudging medical decision-makers to advance financial interests, as opposed to the patients’ well-being. Lilly is suing four compounders, all telehealth platforms that the pharma claims are “putting patients at risk by engaging in dangerous, deceptive, and unlawful practices.”
Lilly in its lawsuit claimed that one plaintiff—Aios Inc, which runs the men’s and women’s health platforms Fella Health and Delilah, respectively—“makes sweeping corporate decisions that dictate patient care,” pointing to a case when Fella “changed patients en masse from one tirzepatide formulation to another with additives.” In this instance, patients were shifted to a product with l-arginine or glycine, neither of which have been tested in combination with tirzepatide, according to Lilly.
Another plaintiff, California- and Washington-based Mochi Health and its owners, who are not licensed physicians, similarly “exercise undue influence and control over … the prescribing decisions of physicians” at the affiliated Mochi Medical, according to Lilly’s complaint. This corporate interference, according to the pharma, is prohibited under California law.
“Over the span of just eight months, Mochi Health switched dosages and prescriptions for patients en masse at least five times—with corporate interests, rather than doctor decision-making—driving the changes,” Lilly claimed, asserting that there was “no patient-specific or medical reason” for these switches.
Lilly is also suing Texas-based Willow Health and California-based Henry Meds for alleged deceptive practices. Willow markets knockoff tirzepatide for cosmetic purposes, which it has not been approved for, Lilly asserted. The FDA has cleared the use of tirzepatide for type 2 diabetes, under the brand name Mounjaro, and for chronic weight management and obstructive sleep apnea, for which it is marketed as Zepbound.
Lilly—alongside its fellow obesity leader Novo Nordisk—has long clashed with compounders over the copycat versions of tirzepatide. The issue came to a head in October 2024, when the FDA first announced that the tirzepatide shortage was over, effectively disallowing the drug from being compounded.
The Outsourcing Facilities Association, which represents FDA-registered compounding pharmacies, blasted the decision days later and sued the regulator, claiming that the move was “arbitrary,” without “any semblance of lawful process.”
