Eli Lilly sues companies selling compounded versions of Zepbound and Mounjaro

Key takeaways

• Eli Lilly has filed lawsuits against four telehealth companies—Mochi Health, Fella Health, Willow Health, and Henry Meds—accusing them of deceptively marketing and selling compounded versions of its FDA-approved drugs, Mounjaro and Zepbound.

• Lilly alleges these companies are promoting untested and unapproved drugs while steering patients away from its branded medications, despite compounding rules requiring tailored solutions for individual patient needs.

• The legal action also questions the safety of the compounded drugs and challenges whether the defendants are violating FDA rules by mass-marketing rather than customizing medications, even though a drug shortage in 2022 had temporarily permitted compounding of Mounjaro.

Eli Lilly has filed lawsuits against four telehealth companies it says are selling compounded versions of Mounjaro, Lilly’s diabetes drug, and Zepbound, a drug for weight loss and control.

Lilly’s lawyers say the four sites –  Mochi Health, Fella Health, Willow Health and Henry Meds – are engaging in deceptive behavior as they market the compounded versions of Lilly’s popular medications.

The U.S. Food and Drug Administration allows compounding pharmacies to make versions of an approved drug if it is in short supply. Because of the enthusiastic consumer demand for GLP-1 weight loss drugs, Mounjaro was declared to be in short supply in 2022, allowing compounding pharmacies to make and sell a version.

‘Untested and unapproved’

The complaint alleges that the four telehealth sites are guiding patients away from Lilly’s versions of the two drugs and toward their own “untested, unapproved drugs.” According to CNBC, the four defendant companies have not commented on the litigation.

Lilly’s suit accuses the defendants of offering personalized options but are really mass-marketing different versions of Lilly’s drugs. 

Under compounding pharmacy rules, the pharmacies are allowed to make the drugs but must tailor medications to meet the unique needs of patients. This might involve:

• Changing the dosage or strength of a medication.

• Removing allergens or non-essential ingredients (like dyes or preservatives).

• Creating a different form (e.g., turning a pill into a liquid).

• Combining multiple medications into a single dosage.

These customized formulations are especially helpful for patients with allergies, difficulty swallowing pills, or specific dosage needs not met by mass-produced drugs.

In its suit, Eli Lilly also calls into question the safety of the compounded versions.