Lilly sues Strive and Empower over compounded tirzepatide

Eli Lilly filed lawsuits on Tuesday, April 1, 2025, against two compounding pharmacies — Strive Pharmacy in Delaware federal court and Empower Pharmacy in New Jersey federal court — accusing them of continuing to make copies of Zepbound and Mounjaro after the FDA's tirzepatide shortage ended ^[1][4]. Weeks later, on April 23, Lilly filed four more suits in California federal courts against telehealth companies Fella Health, Willow Health, Henry Meds and Mochi Health ^[3][4].

The core allegation is the same across the cases: that the companies falsely market compounded tirzepatide as "personalized" versions of the drug when they are really mass-produced, and that they lean on Lilly's clinical testing to sell products the FDA has never reviewed ^[1][4]. Lilly's claims include deceptive and unfair trade practices and false or misleading advertising ^[4]. In the Fella complaint, Lilly states that its medicines "have undergone 37 clinical trials," that Mounjaro and Zepbound are "the only FDA-approved tirzepatide medicines," and that they are approved only for under-the-skin injection without additives like glycine or l-arginine ^[3].

The backdrop is the end of the shortage. Tirzepatide was in shortage for about two years, which legally allowed compounders to make copies ^[4]. The FDA first announced the shortage was over in October 2024, affirmed it in December 2024, and gave compounders until March 19, 2025, to stop ^[2]. Some kept going by tweaking dosages or mixing tirzepatide with vitamins — differences that they argue make their products distinct from Lilly's and outside the ban ^[1]. Lilly argues that is mass production dressed up as customization; outside a shortage, custom versions are meant for unique situations, such as an allergy to an ingredient ^[1].

The telehealth complaints add specific accusations. Lilly says Fella "changed patients en masse from one tirzepatide formulation to another with additives" — l-arginine or glycine — neither of which Lilly says has been tested in combination with tirzepatide ^[2]. It claims Mochi Health "switched dosages and prescriptions for patients en masse at least five times" over eight months, with "no patient-specific or medical reason" ^[2]. Against Mochi and Fella, Lilly also alleges the unlicensed corporate practice of medicine, which California law restricts under Business and Professions Code Sections 2052 and 2400 ^[4]. Willow is accused of marketing tirzepatide for cosmetic purposes it was never approved for ^[2].

The companies pushed back. Empower said restricting access to personalized alternatives is not in patients' best interest and that it is "committed to offering these life-changing formulations" ^[1]. Strive called the suit "a classic example of Big Pharma overstepping legitimate regulations" and said it will defend itself ^[1]. Mochi said it does not anticipate interruptions in patient care and that compounded medications are "appropriate and legal when tailored to individual patient needs... not as mass-market substitutes for branded medications" ^[1][3].

Why it matters for patients

Many people started on compounded tirzepatide because it was cheaper or easier to get than Zepbound or Mounjaro. These suits target the supply chain behind that market — Strive and Empower supply telehealth sites including Lavender Sky Health and Mochi Health ^[1] — so outcomes could affect whether those products stay available.

The FDA states plainly that compounded drugs are not FDA approved, meaning the agency does not verify their safety, effectiveness or quality before marketing, though compounded drugs can serve an important medical need for some patients ^[3]. Lilly's filings highlight that oral tirzepatide, drops, and combinations with glycine or l-arginine have not been studied in its trials ^[3][4]. Whether any of these products cause harm is not established in these sources; the complaints are allegations, not findings.

What happens next

Courts have not ruled. Holland & Knight notes adjudication of Lilly's claims "is possibly years away," and expects more suits ^[4]. Lilly had already taken action against more than two dozen medical spas, wellness centers and pharmacies earlier in April ^[3]. The Outsourcing Facilities Association has separately sued the FDA, calling the shortage decision "arbitrary" ^[2]. Semaglutide compounding faced its own cutoff after the end of May 2025, and these cases could shape how Novo Nordisk responds ^[1].