Lilly sues two pharmacies and four telehealth firms over compounded tirzepatide

Eli Lilly sued two compounding pharmacies on April 1, 2025, accusing them of making and selling compounded versions of tirzepatide — the active ingredient in its diabetes drug Mounjaro and its weight-loss drug Zepbound — after federal regulators said the practice should largely stop ^[1]. The suits against Strive Pharmacy and Empower Pharmacy were filed in Delaware and New Jersey ^[1][4]. Later in April, Lilly filed four more lawsuits in California federal courts against the telehealth companies Fella Health, Willow Health, Henry Meds and Mochi Health ^[2][3][4].

The FDA affirmed in December 2024 that tirzepatide was no longer in shortage, which barred compounders from producing their own versions and gave them until March 19 to comply ^[2]. Large-scale compounding is allowed while a drug is in shortage. Outside a shortage, custom versions can be made for unique situations, such as when a patient is allergic to an ingredient or cannot take the form the drug is normally sold in ^[1]. A Lilly spokesperson said that while many compounders had stopped, "some bad actors have not" ^[2].

In the first two suits, Lilly argues Strive and Empower are mass-producing altered versions of tirzepatide rather than personalizing them, and falsely marketing the products as personalized versions of drugs that have been clinically tested ^[1]. Lilly's claims include deceptive and unfair trade practices and false or misleading advertising ^[4]. Empower said in a statement that restricting access to personalized alternatives to commercial drugs is not in the best interest of patients and that it is "committed to offering these life-changing formulations" ^[1]. Strive called the lawsuit a classic example of Big Pharma overstepping legitimate regulations to prioritize its own interests and said it will vigorously defend its position ^[1]. Both pharmacies supply tirzepatide to telehealth sites, including Lavender Sky Health and Mochi Health ^[1]. Mochi said it does not anticipate interruptions or delays in patient care and remains confident in the integrity of its clinical approach ^[1]. Lavender Sky Health did not respond to a request for comment ^[1].

The four April lawsuits against telehealth companies make similar allegations ^[2][3]. Lilly claims that Aios Inc., which runs Fella Health and Delilah, "changed patients en masse from one tirzepatide formulation to another with additives," moving patients to products containing l-arginine or glycine, neither of which has been tested in combination with tirzepatide ^[2]. Lilly says Mochi Health switched dosages and prescriptions for patients en masse at least five times in eight months, with "no patient-specific or medical reason" ^[2]. Lilly also says Willow Health markets compounded tirzepatide for cosmetic purposes, which it is not approved for ^[2]. The FDA has approved tirzepatide as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management and obstructive sleep apnea ^[2].

Lilly's complaint against Fella says its medicines have undergone 37 clinical trials and are "the only FDA-approved tirzepatide medicines," approved only for injection under the skin and without additives such as glycine or l-arginine ^[3]. Lilly says Fella cites the results of Lilly's clinical trials to market oral and injectable compounded tirzepatide, but those trials did not evaluate oral tirzepatide or tirzepatide combined with those additives, and Lilly is not aware of any trials that did ^[3]. A Mochi spokesperson said the company's licensed physicians alone decide which treatments are best for patients, and that compounded medications remain appropriate when tailored to individual needs rather than sold as mass-market substitutes ^[3]. Earlier in April, Lilly also took legal action against more than two dozen medical spas, wellness centers and compounding pharmacies over products they said contained tirzepatide ^[3].

Why it matters for patients

Compounded drugs are not FDA approved, which means the agency does not verify their safety, effectiveness or quality before they are marketed, according to the FDA ^[3]. The FDA-approved forms of tirzepatide are given by injection under the skin and contain no additives like glycine or l-arginine ^[3]. Many consumers report positive experiences with compounded drugs, and they are increasingly used as lower-cost alternatives ^[4]. Whether patients now receiving compounded tirzepatide will face supply changes has not been disclosed beyond Mochi's statement that it expects no delays ^[1]. How the courts will rule, and whether any patients were harmed, has not been established. The suits are the first test of Lilly's ability to take on compounders in court now that tirzepatide is off the shortage list, and could offer a roadmap for other drugmakers ^[1].

What happens next

Compounding of tirzepatide was supposed to stop by March 19 ^[2]. Novo Nordisk's Wegovy and Ozempic generally cannot be compounded after the end of May ^[1]. Adjudication of Lilly's claims is possibly years away ^[4]. No hearing dates or rulings have been reported.