Court dismisses Lilly's complaint against a compounded tirzepatide telehealth seller

A federal judge in the Central District of California has dismissed Eli Lilly and Company's first amended complaint against Willow Health Services, Inc., a telehealth platform that sells compounded tirzepatide products. Judge André Birotte Jr. granted Willow's motion to dismiss on February 3, 2026, and denied as moot a separate motion to stay discovery ^[1].

Lilly sued Willow under the Lanham Act, arguing that Willow's marketing falsely presented its compounded tirzepatide as "clinically proven" and comparable to, or better than, Lilly's approved drugs, even though Willow's products have not undergone clinical trials ^[1]. The complaint said Willow sells both an injectable formulation and an oral "Tirzepatide Drops" product, even though no oral tirzepatide has been approved by the FDA and Lilly does not sell one ^[1]. Willow moved to dismiss on two grounds: that Lilly lacked standing to sue, and that the marketing statements at issue were not legally actionable ^[1]. The court's order does not reproduce its full reasoning on these points beyond stating that the motion was granted.

The opinion also lays out background facts about the regulatory landscape. It states that Lilly currently holds regulatory exclusivity for tirzepatide that bars the FDA from accepting applications for competing tirzepatide products until at least May 2027 ^[1]. Mounjaro, approved for adults with type 2 diabetes, and Zepbound, approved for chronic weight management and obstructive sleep apnea in certain adults, are described as the only FDA-approved medications containing tirzepatide, and both are administered only by injection ^[1]. Compounded drugs like Willow's are not reviewed by the FDA for safety, effectiveness, or manufacturing quality before reaching patients, and compounding pharmacies are not held to the same manufacturing standards, inspections, or adverse-event reporting rules as FDA-approved drugmakers ^[1].

The complaint cited outside research on consumer understanding of compounded GLP-1 drugs. A National Consumers League survey found many consumers wrongly believe compounded GLP-1 products are FDA-approved and clinically tested, and a study in JAMA Health Forum concluded that most websites advertising compounded GLP-1 drugs give limited safety information alongside unauthorized efficacy claims ^[1]. This is the second time a Lilly complaint against Willow has been dismissed: the court dismissed Lilly's original complaint on August 29, 2025, but allowed Lilly to file an amended version, which was dismissed again this February ^[1].

Why it matters for patients

This ruling is about advertising law, not about whether compounded tirzepatide is safe or effective. The dismissal does not mean Willow's marketing claims were found to be true, and it does not change the underlying regulatory facts described in the opinion: Mounjaro and Zepbound remain the only tirzepatide products the FDA has approved, both are injectable, and compounded versions — including any oral drops — have not gone through FDA review for safety or effectiveness ^[1]. For people comparing telehealth offers of compounded tirzepatide against Lilly's approved drugs, the case is a reminder that marketing language like "clinically proven" or "personalized" describing a compounded product does not carry the same regulatory backing as an FDA approval ^[1].

What happens next

The order does not state whether Lilly can file a second amended complaint or whether it plans to appeal. It is not yet known from the available record what Lilly's next legal step will be, or whether other manufacturers or regulators will take separate action regarding compounded tirzepatide marketing.