September 8, 2025 – A significant legal development unfolded last week when U.S. District Judge Andre Birotte Jr. dismissed Eli Lilly’s lawsuit against Willow Health, a telehealth company compounding tirzepatide. The ruling is the latest in a series of high-profile disputes between major pharmaceutical manufacturers and compounding pharmacies over access to GLP-1 medications such as Mounjaro and Zepbound.
This case underscores the growing tension between branded drug makers seeking to protect market share and compounding pharmacies leveraging clinical demand and legal frameworks to expand patient access.
Key Findings from the Court
Judge Birotte’s opinion sharply narrowed Lilly’s claims, providing a roadmap for how future cases may be decided:
- No proof of lost sales. Lilly failed to show that any patients or physicians switched from its branded products to Willow Health’s compounded alternatives. General allegations of reputational harm were insufficient.
- California claims fell short. Under California’s Unfair Competition Law (UCL) and False Advertising Law (FAL), plaintiffs must prove lost money or property. The court held Lilly had not met that burden.
- Advertising arguments were weak.
- Referring to compounding as “personalized” was consistent with established legal requirements.
- Statements about pharmacy checks were treated as opinions, not actionable misrepresentations.
- Challenges to clinical trial descriptions were not claims private companies can enforce under California law.
The dismissal was issued without prejudice, giving Lilly 30 days to amend its complaint and refile with stronger evidence.
What This Means for Compounding and Healthcare Practices
Judge Birotte’s ruling sends a clear signal: brand-name manufacturers cannot shut down compounding with broad, speculative claims alone. To succeed, they must provide direct evidence that prescriptions or sales were diverted.
For providers, the decision has several important implications:
- Compounding remains lawful and protected. When compounded under a physician’s supervision and tailored to an individual patient’s need, GLP-1 preparations continue to be a valid option.
- Telehealth legitimacy reinforced. The ruling validates telehealth models that include physician consultations and individualized treatment plans—critical for clinics offering patient-specific compounded therapies.
- Reduced near-term litigation risk. While lawsuits may continue, this decision reduces the immediate threat to providers and patients relying on compounded GLP-1s amid ongoing cost and supply challenges with branded products.
What’s Next?
Lilly still has the option to amend and refile its complaint. To survive dismissal, it would likely need:
- Physician testimony showing patients switched from branded to compounded products,
- Patient surveys demonstrating confusion or diversion, or
- Insurance or prescription records proving financial impact.
So far, Lilly has framed its lawsuits as being about patient safety, but courts are scrutinizing whether the real issue is market protection.
This case is one of several ongoing suits Lilly has filed against telehealth providers such as Mochi Health, Fella Health, and Henry Meds, reflecting a broader strategy to challenge compounded GLP-1s industrywide.
Bottom Line
The dismissal of Lilly v. Willow Health is a pivotal moment in the battle over compounded GLP-1 medications. It reaffirms that:
- Compounding remains a lawful and legitimate medical practice when done under proper clinical oversight.
- Drug manufacturers face an uphill battle unless they can demonstrate concrete harm.
- Healthcare providers, telehealth platforms, and patients can continue accessing compounded GLP-1s—at least for now—without fear of immediate legal shutdowns.
As litigation unfolds, this case will likely shape the future of GLP-1 access, telehealth innovation, and the balance between patient care and pharmaceutical market control.