^{Photo: Scott Olson}

Eli Lilly & Co. has initiated lawsuits against four telehealth companies—Mochi Health, Fella Health, Willow Health, and Henry Meds—accusing them of selling unauthorized compounded versions of tirzepatide, the active ingredient in its FDA-approved drugs, Mounjaro and Zepbound. ​

Background

Tirzepatide, a GLP-1 receptor agonist, is approved for treating type 2 diabetes and chronic weight management. During shortages declared by the FDA, compounding pharmacies were permitted to produce versions of such drugs. However, the FDA announced the resolution of the tirzepatide shortage in December 2024, setting deadlines for compounders to cease production: February 18, 2025, for state-licensed pharmacies and March 19, 2025, for outsourcing facilities. ​‍

Allegations

Lilly's lawsuits allege that the defendants:​

• Marketed unapproved tirzepatide products, including oral versions and formulations with additives like vitamins and amino acids, without proven safety or efficacy. ​
• Claimed to offer personalized treatments while actually mass-producing these variants.​
• Engaged in practices that could mislead consumers and divert them from FDA-approved medications.​

For instance, Lilly asserts that Mochi Health's CEO, Myra Ahmad, is not a licensed physician and that the company exerts undue influence over prescribing decisions, constituting unlawful medical practice. ​

Industry Impact

The compounded versions of tirzepatide gained popularity due to their lower cost, with some priced as low as $199 per month compared to the branded versions costing between $1,000 and $1,300 monthly.  Approximately 2 million patients used these alternatives in the past year. However, with the FDA's shortage declaration lifted, many compounders are required to halt production, affecting patient access to affordable treatments.​‍

Regulatory Actions

The FDA has clarified that while it provided a grace period for compounders to cease production, it may still take action against violations related to product quality or safety.  Additionally, the agency emphasized that compounded medications are not FDA-approved and should only be used when no approved alternatives are available. ​‍

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Eli Lilly's legal actions underscore the company's commitment to protecting its patented medications and ensuring patient safety. As the pharmaceutical landscape evolves, the balance between drug accessibility and regulatory compliance remains a critical issue.​

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