Compounded & telehealth

Lilly vs the Compounders: The Legal Fight Over Tirzepatide, Explained

Eli Lilly has sued compounding pharmacies, telehealth platforms, medspas and peptide sellers over knockoff tirzepatide, and fought the compounders at FDA, in federal court and at the ITC. Here's who sued whom, what courts have decided, and what it means if you're a patient.

Last verified September 14, 2026·10 sources cited

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The fight over compounded tirzepatide has been argued in four different places at once: at FDA, in federal district courts, at a federal appeals court, and at a trade tribunal that most people have never heard of.

This page untangles it. It is not legal advice, and none of these cases tells any individual what to do about their own prescription.

What is Lilly’s basic argument?

Short version: once FDA declared the tirzepatide shortage over, the legal permission that allowed mass compounding disappeared, and anyone still doing it is selling an unapproved drug while trading on Lilly’s reputation.

Lilly’s own words to NPR in 2025: “Anyone continuing to sell mass compounded tirzepatide is breaking the law and deceiving patients. We will continue to take action to stop those who threaten patient safety and urgently call on regulators and law enforcement to do the same” [1].

What is notable is what Lilly usually does not sue over. In most of these cases there is no patent claim. The complaints are built on false advertising, unfair competition, state consumer-protection statutes and, in a few, the corporate practice of medicine — the rule in many states that only licensed clinicians, not corporations, may control medical decisions.

How did the campaign unfold?

It started earlier than most coverage suggests.

September 2023 — Lilly filed suits against eight companies and, separately, against ten medspas, wellness centers and compounding pharmacies in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah for selling products claiming to contain tirzepatide.
October 19, 2023 — Lilly filed a complaint with the U.S. International Trade Commission against eleven online sellers of imported tirzepatide products [2].
October 2024 — Lilly sent cease-and-desist letters to hundreds of compounding pharmacies, telehealth companies and medspas [3].
April 1, 2025 — Lilly sued two compounding pharmacies, Strive in Delaware and Empower in New Jersey [4]. The Empower litigation that produced the 2026 ruling below was subsequently brought in the Southern District of Texas (No. H-25-3464), where Empower is based [11].
April 23, 2025 — Lilly sued four telehealth companies: Mochi Health, Fella Health and Delilah, Willow Health Services and Henry Meds [5].
October 2025 — Trade coverage reported Lilly had sued companies in 34 states.
August 12, 2026 — Lilly filed its first six lawsuits over retatrutide, its unapproved investigational drug [6].
September 2026 — A Lilly spokesperson said the company had obtained more than a dozen permanent injunctions against telehealth companies, medspas and mass compounders [7].

What did Lilly accuse the telehealth companies of?

The four April 2025 complaints share a theme: that these platforms claimed to offer personalized medicine while actually mass-marketing slightly altered versions of Lilly’s drug.

Mochi Health. Lilly alleged Mochi switched patients among tirzepatide formulations and additives such as niacinamide “at least five times in just eight months,” and moved them to lower doses that had never been studied, for business rather than medical reasons. Lilly also alleged that Mochi’s unlicensed owners exercised undue influence over prescribing decisions at the affiliated medical group [8].

Fella Health and Delilah. Lilly alleged a conspiracy with Fella Medical Group to sell untested, unapproved weight-loss drugs; that Fella sold an oral tirzepatide and told patients it was better than Lilly’s approved medicines; and that non-physicians gave medical advice, including on Reddit [9].

Willow Health Services. Lilly targeted two named products, “Tirzepatide Drops” and “Tirzepatide Plus,” the latter mixed with niacinamide. Lilly alleged Willow falsely claimed to have developed the first “cosmetic” GLP-1 — FDA has never approved any tirzepatide for cosmetic weight loss — and that its claim that partner pharmacies “pass rigorous evaluations” was untrue [10].

Henry Meds. Lilly focused on Henry’s under-the-tongue oral tirzepatide, calling it “an untested knockoff that exposes patients to safety risks” because no clinical study has found orally administered tirzepatide safe and effective [5].

And the compounding pharmacies?

Empower Pharmacy (Houston) makes two tirzepatide products according to the complaint: Tirzepatide ODT, an orally dissolving tablet, and injections combining tirzepatide with niacinamide, at a scale Lilly put at 70,000 doses per week [11]. Empower’s public response has been that restricting access to personalized alternatives is not in patients’ best interest and that it stands by its mission.

Strive Compounding Pharmacy (Arizona) sells what it calls a personalized combination of tirzepatide, vitamin B12 and glycine, shipped to providers and patients nationwide. Lilly’s complaint expressly challenged Strive’s online statements rather than its drug sales. Strive called the suit “a classic example of Big Pharma overstepping legitimate regulations” [4].

What have the courts actually decided?

This is where the story stops being one-sided. Lilly has had a rough run on its strongest federal theory.

Strive: dismissed on jurisdiction. On October 8, 2025, Judge Stephanos Bibas of the District of Delaware dismissed Lilly’s complaint without prejudice for lack of personal jurisdiction. The opinion opens with a line worth quoting: “Our legal system rewards innovative drug development, not innovative jurisdictional theories.” The court found Lilly had not connected Strive’s online advertising to Delaware, since the posts “were not ‘aimed’ anywhere but the World Wide Web,” and told Lilly it could plead more facts or sue in Arizona [12]. The dismissal was without prejudice and Lilly has since refiled.

Empower: federal claim out, state claims in. On April 29, 2026, Judge Sim Lake of the Southern District of Texas dismissed Lilly’s Lanham Act false-advertising claim, applying the Supreme Court’s Lexmark framework. Lilly cleared the “zone of interests” test but failed on proximate causation: alleging that “some sales” would have been Lilly’s fell short of the near one-to-one link Lexmark requires, and the theory that consumers might blame Lilly for adverse events was too speculative. The Texas common-law claim was also dismissed. But state consumer-protection claims under the laws of Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington survived, because the court found they rest on independent state duties not to sell unapproved new drugs rather than on federal law [11].

Willow: same result. A February 3, 2026 ruling in the Central District of California dismissed Lilly’s Lanham Act claim on the same proximate-causation grounds.

Mochi: trimmed twice, still alive. Judge Jacqueline Scott Corley dismissed Lilly’s original complaint with leave to amend, for failure to plausibly allege Article III standing. On April 20, 2026 she ruled on the amended complaint and largely went the other way: Lilly had plausibly alleged standing and both its California Unfair Competition Law claim and its Lanham Act false-advertising claim survived, while the civil conspiracy count was dismissed [7a]. Then on September 8, 2026 she trimmed it again — dismissing the Lanham Act conspiracy claims against both the Mochi medical defendants and the pharmacy, while letting UCL conspiracy claims proceed against Mochi’s supplier, Aequita Pharmacy, and its parent, Aequita Corporation. The court found Lilly had plausibly alleged that Mochi’s chief executive had “significant control” over Aequita’s prescription-filling procedures and that Aequita had “significant financial motivation” to participate. Lanham Act claims were dismissed without leave to amend unless discovery turns up supporting facts [7].

Note that widely circulated summaries describing the April 2026 order as having “cut the Lanham Act claims” are inaccurate; that order preserved the Lanham Act claim and dismissed the conspiracy count.

The pattern: federal false-advertising claims are hard to win at the pleading stage. The fight has migrated to state consumer-protection law, which is why the Empower ruling listing eight states matters more than its headline loss.

Did the compounders fight back?

Twice, and both efforts failed.

Against FDA. The Outsourcing Facilities Association and FarmaKeio sued FDA to reverse the tirzepatide delisting, arguing the agency should have used notice-and-comment rulemaking. The district court denied a preliminary injunction in March 2025 and ruled for FDA in May 2025. On August 27, 2026 the Fifth Circuit affirmed in No. 25-10600, holding any procedural error harmless and the shortage determination not arbitrary or capricious [13]. A companion opinion decided the semaglutide appeal the same day. Both are unpublished, so persuasive rather than binding, but they end the litigation absent further review.

Against the manufacturers. Strive Specialties sued Eli Lilly and Novo Nordisk on January 14, 2026 in the Western District of Texas, alleging the companies used exclusive supply agreements to bar telehealth platforms from buying GLP-1s from compounding pharmacies, in violation of the Sherman and Clayton Acts. On August 3, 2026 Senior Judge Micaela Alvarez dismissed the case with prejudice. The reasoning is significant well beyond this case: compounded GLP-1s are not reasonably interchangeable with the branded drugs, because their use is governed by medical necessity and regulatory constraints rather than consumer preference, so they are not in the same product market and there is no antitrust injury [14].

Read together, those two rulings say something blunt. The compounders cannot get the shortage back, and they cannot characterize themselves as competitors who were unfairly excluded.

What is the ITC case?

A separate track, and an underrated one.

Lilly’s October 2023 complaint to the U.S. International Trade Commission named eleven online sellers of products containing or purporting to contain tirzepatide, including U.S. firms Arctic Peptides, Strate Labs, Supopeptide, Triggered Supplements and Unewlife, plus sellers in the United Kingdom, Spain, Poland, China and Hong Kong. The ITC instituted Investigation No. 337-TA-1377 [15].

On April 9, 2025 the Commission issued:

a general exclusion order barring importation of products containing or purporting to contain tirzepatide that infringe U.S. Trademark No. 6,809,369 or carry a false designation of origin;
a limited exclusion order against three respondents; and
cease and desist orders against Arctic Peptides, Triggered Brand and Strate Labs [16].

The general exclusion order is the part that matters to consumers. It applies to any importer, not just the named companies. Gray-market tirzepatide powder ordered from abroad is subject to it.

Testing in that case produced one of the most quoted findings in this whole story: Lilly said a product purporting to contain tirzepatide “was actually selling nothing more than sugar alcohol” [17].

What about retatrutide?

On August 12, 2026 Lilly filed six lawsuits against Aesthetic Envy Cosmetic Centers (a California medspa), Striker Pharmacy (a licensed compounding pharmacy), Lone Star Peptide, Texas Peptides, Astra Peptides and Legendary Peptides, over sales of retatrutide [6].

Retatrutide is Lilly’s investigational triple agonist. It has never been approved anywhere in the world, which removes every argument that applied to tirzepatide: it was never in shortage, it is not a component of any approved drug, and FDA has said it cannot be used in compounding under federal law.

The complaints plead state consumer-protection claims from eight states plus a single Lanham Act count against the medspa — a structure that looks like a direct response to the Lanham Act losses. Lilly also said it had referred more than 200 individuals and entities to FDA, DOJ, state attorneys general, law enforcement and licensing boards.

Naming a licensed compounding pharmacy was the pointed part. A pharmacy has a state license to lose.

Where do regulators fit?

Alongside the private litigation, three layers of enforcement have been running:

FDA. Thirty warning letters to telehealth companies on March 3, 2026 for false or misleading compounded GLP-1 claims, with court filings putting the total above 100 marketing letters since September 2025. Separately, batches of letters to research-peptide sellers in March and August 2026 citing tirzepatide by name.
State attorneys general. Connecticut settled with a research-grade seller for a $300,000 judgment suspended after $18,500, with a medspa over compounded tirzepatide advertising, and with the trade platform Made-in-China in May 2026. Alabama shut a Cullman clinic permanently in January 2026 after finding it injected research-grade semaglutide and tirzepatide marketed as pharmaceutical grade.
The FTC, whose NextMed order constrains how any weight-loss program advertises cost, reviews and typical results.

What does this mean if I’m a patient?

Three practical things.

Nobody is coming after patients. None of these cases targets the person taking the medicine.

Supply continuity is the real risk. A provider that loses a case, settles, receives a warning letter or closes can end your access with little notice. If you are on a compounded product, it is worth asking your prescriber now what happens if the supply stops, rather than finding out at a refill.

Litigation status is a useful screening signal. A platform named in an active manufacturer suit or an FDA warning letter is not automatically unsafe, and allegations are only allegations. But it tells you the company’s marketing has already been examined by people with subpoena power, and that is worth knowing before you prepay for six months.

Whether any GLP-1 is right for you remains a question for a healthcare provider who knows your history.

Sources

Questions people ask

Why is Eli Lilly suing compounding pharmacies and telehealth companies?

Lilly's position is that once FDA declared the tirzepatide shortage resolved, anyone still selling mass-compounded tirzepatide is breaking the law and deceiving patients. Its suits generally allege false advertising, unfair competition and, in some cases, unlawful corporate practice of medicine — not patent infringement.

Has Lilly won these cases?

Mixed. Lilly's federal Lanham Act false-advertising claims have repeatedly been dismissed for failure to show that a compounder's marketing directly caused Lilly's lost sales. State consumer-protection and unfair-competition claims have survived in several cases. Lilly says it has obtained more than a dozen permanent injunctions.

Who did Lilly sue?

Compounding pharmacies including Strive and Empower; telehealth companies Mochi Health, Fella Health and Delilah, Willow Health Services and Henry Meds; medspas and wellness centers across many states; online peptide sellers; and, in a separate ITC case, eleven online sellers of imported tirzepatide products.

Did anyone sue Lilly back?

Yes. Strive Specialties sued Eli Lilly and Novo Nordisk for antitrust violations in January 2026, alleging exclusive agreements that barred telehealth platforms from buying from compounding pharmacies. A federal judge dismissed the case with prejudice in August 2026.

Does any of this affect me if I take compounded tirzepatide?

No court has ordered patients to do anything. The practical effect is on supply: a provider that loses a case, settles or shuts down can end a person's access abruptly. Talk to your healthcare provider about continuity before that happens.

What is the ITC case about?

A trade case, not a health case. In 2025 the U.S. International Trade Commission issued a general exclusion order barring importation of products containing or purporting to contain tirzepatide that infringe Lilly's Mounjaro trademark or carry a false designation of origin. A general exclusion order reaches any importer, not just the named companies.

Why does Lilly keep losing its Lanham Act claims?

Courts apply the Supreme Court's Lexmark framework, which requires a plaintiff to show a close causal link between the defendant's deceptive advertising and its own lost sales. Judges have found Lilly's allegations that some sales would have been its own too speculative to meet that standard.

What is retatrutide and why is Lilly suing over it?

Retatrutide is Lilly's investigational triple agonist, not approved anywhere in the world. Because it was never approved and never in shortage, no compounding exception has ever applied to it. Lilly filed six lawsuits over retatrutide sales on August 12, 2026.

This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.