Reporting puts compounded tirzepatide as low as $99 a month

Eli Lilly has sued four telehealth companies, adding to earlier lawsuits against compounding pharmacies, as it moves to shut down sales of copies of its weight loss drug Zepbound after a federal shortage designation ended ^[1]. NPR's reporting lays out the price gap at the center of the fight: Zepbound's list price tops $1,086.37 a month, while compounded tirzepatide has sold for as little as $99 a month ^[1].

Tirzepatide, the active ingredient in both Zepbound and Mounjaro, was on the FDA's shortage list for two years until Dec. 19, 2024 ^[1]. During a shortage, compounding pharmacies are allowed to make copies of brand-name drugs. The FDA required compounders to stop making new copies of tirzepatide by mid-March, though pharmacies could keep selling existing stock until it ran out or expired ^[1].

On April 23, Lilly filed complaints against Mochi Health, Willow Health, Fella Health and Delilah, and Henry Meds ^[1]. One complaint alleges Mochi switched patients to compounded tirzepatide with different additives, such as niacinamide, and to different doses than Lilly's approved products, changing formulations "at least five times in just eight months" to keep selling compounded versions ^[1]. Federal law bars compounders from making something that is "essentially" a copy of an already available commercial drug ^[1].

Other complaints raise separate claims. Lilly alleges Henry Meds referenced its approved drugs and clinical trials on its website to market compounded versions, and that Henry Meds and Fella Health sold tirzepatide in pill form, a version never approved by the FDA ^[1]. Lilly's complaint against Fella alleges the company told patients its untested oral drug is better than Lilly's approved medicines ^[1]. The complaint against Willow Health alleges the company falsely claimed to have developed the first "cosmetic" GLP-1, when the FDA has never approved any form of tirzepatide for cosmetic weight loss and Lilly makes the only FDA-approved version ^[1]. Earlier, on April 1, Lilly sued compounding pharmacies Strive and Empower; Strive says it will fight back, and Empower said in a statement that it "stands by" its mission and the patients and providers who depend on it ^[1].

Why it matters for patients

Patients who turned to compounded tirzepatide, often because they lacked insurance coverage or could not afford Zepbound's list price, are caught in the middle of this legal fight ^[1]. Some may be taking versions with different additives or doses than what Lilly's FDA-approved products contain, changes made, according to Lilly's complaint, to keep pharmacies selling as legal shortage exceptions closed ^[1]. Oral compounded tirzepatide, sold by at least two of the sued companies, has never been reviewed or approved by the FDA in any form ^[1]. As lawsuits proceed, patients relying on compounded versions may see supply, pricing, or availability shift depending on outcomes in court and how individual pharmacies and telehealth companies respond.

Scott Brunner, head of the Alliance for Pharmacy Compounding, told NPR the legal question is not clear-cut: he says there is no "bright line" between improper corporate practice of medicine and legitimate customization of a drug based on a prescriber's judgment for an individual patient ^[1]. He said federal guidance clearly allows the latter, but said the dividing line "will be a Federal judge" in these new cases ^[1].

What happens next

The lawsuits Lilly filed on April 1 against Strive and Empower, and the April 23 complaints against Mochi Health, Willow Health, Fella Health, Delilah, and Henry Meds, are pending in federal court ^[1]. NPR reports Strive intends to contest the suit, while Empower has posted a public statement defending its practices ^[1]. Several of the named companies, including Mochi Health, Henry Meds, Fella Health, and Willow Health, did not respond to NPR's requests for comment as of publication ^[1].