Court dismisses Lilly lawsuit against compounded tirzepatide seller Willow Health

A federal judge in Los Angeles dismissed Eli Lilly's false-advertising lawsuit against Willow Health Services, a telehealth company that sells compounded tirzepatide, the active ingredient in Mounjaro and Zepbound ^[1]. The order, filed February 3, 2026, granted Willow's motion to dismiss Lilly's first amended complaint and denied as moot Willow's separate motion to stay discovery ^[1].

The case is Eli Lilly and Company v. Willow Health Services, Inc., No. 2:25-cv-03570-AB-MAR, before Judge André Birotte Jr. in the U.S. District Court for the Central District of California ^[1]. It is the second dismissal in the dispute. The court granted Willow's motion to dismiss the original complaint on August 29, 2025, and allowed Lilly to amend; Lilly filed its first amended complaint on September 30, 2025 ^[1]. Willow then asked the court to dismiss that amended complaint on two grounds: that Lilly had not sufficiently alleged standing, and that the advertising at issue is not actionable under the Lanham Act, the federal law covering false advertising ^[1]. The order granted the motion ^[1].

What the order records about tirzepatide

The order states that the FDA has approved two injectable tirzepatide medicines: Mounjaro for adults with type 2 diabetes, and Zepbound for chronic weight management and obstructive sleep apnea in certain adults ^[1]. It states that these are the only FDA-approved medications containing tirzepatide, that both are given only by subcutaneous injection, and that Lilly does not sell — and the FDA has not approved — any oral tirzepatide formulation ^[1]. The order also records that Lilly currently holds regulatory exclusivity for tirzepatide, which prevents the FDA from accepting applications for competing tirzepatide products until at least May 2027 ^[1].

Willow operates a telehealth platform that markets weight-loss treatments directly to consumers and offers compounded tirzepatide, including an injectable and an oral product it calls "Tirzepatide Drops," according to the order's summary of Lilly's complaint ^[1]. Those products are not FDA-approved and have not undergone clinical trials, and they are compounded from bulk active ingredient sourced from third parties rather than from Lilly, the order states ^[1].

The order describes Lilly's allegations that Willow marketed its products as clinically validated and comparable or superior to Lilly's medicines, using phrases such as "extensive testing," "science," "premium" and "precision medicine," while allegedly compounding standardized formulations and recommending its medication to all users regardless of their answers on an online intake questionnaire ^[1]. Because the case was decided on a motion to dismiss, the court was required to accept the complaint's factual allegations as true for purposes of the ruling ^[1].

The order also summarizes allegations about consumer confusion. It cites a National Consumers League survey finding that many consumers incorrectly believe compounded GLP-1 drugs are FDA-approved and clinically tested, and a study in JAMA Health Forum concluding that most websites advertising compounded GLP-1 drugs provide limited safety information and make unauthorized efficacy claims ^[1]. Lilly further alleged that Willow added a disclaimer after the lawsuit was filed stating its products are not FDA-approved and have not undergone clinical trials, placed at the bottom of a webpage and not prominently displayed ^[1].

Compounded drugs sit outside the FDA's premarket approval process, and the order notes Lilly's allegations that compounding pharmacies are not held to current good manufacturing practice standards, routine inspections or adverse event reporting requirements ^[1]. It also cites FDA warnings about dosing errors, adverse events and unapproved salt forms in compounded tirzepatide, and Lilly's allegation that much of the tirzepatide used for compounding is made overseas, primarily in China, at facilities without the same regulatory oversight as domestic manufacturers ^[1].

Why it matters for patients

Patients choosing between an FDA-approved tirzepatide medicine and a compounded version are weighing products that are regulated very differently. Mounjaro and Zepbound have gone through FDA review for safety and effectiveness; compounded tirzepatide has not, and the FDA does not review compounded drugs for safety, effectiveness or manufacturing quality before they reach patients, according to the order ^[1].

The order also confirms that no oral tirzepatide product has FDA approval, so any oral tirzepatide marketed to consumers is not an approved medicine ^[1]. And the exclusivity noted in the order means competing FDA-approved tirzepatide products cannot enter the market before at least May 2027 ^[1].

A dismissal at this stage is a ruling on the legal sufficiency of Lilly's complaint, not a finding that Willow's advertising is truthful or that it is misleading. It has not been reported whether Lilly will file another amended complaint or appeal, and no further court dates have been disclosed ^[1].

What happens next

The order does not set out any remaining deadlines in the case, and the status of any further filings by Lilly has not been reported ^[1]. The regulatory exclusivity described in the order runs until at least May 2027 ^[1].