The Eli Lilly Lawsuit Over Compounded Tirzepatide: Who's Winning?

Eli Lilly has spent more than three years trying to shut down the market for compounded tirzepatide through lawsuits, cease-and-desist letters and a federal trade case, and so far the results are mixed. Courts have dismissed Lilly’s federal false-advertising claims against several sellers, thrown out its first case against a compounding pharmacy on jurisdictional grounds, and rejected a compounder’s antitrust countersuit — but state-law claims against Empower Pharmacy and Mochi Health are still alive, and an appeals court has upheld the FDA’s decision that ended legal mass compounding ^{[7][11][12][13][14]}. For a patient, the lawsuits target companies, not individuals, and no court has ruled on the truth of most of the allegations, which remain at early procedural stages ^[7][11][12].

The whole fight turns on one date. Tirzepatide, the active ingredient in Lilly’s Mounjaro and Zepbound, was on the FDA’s drug shortage list from December 2022 until October 2, 2024, when the FDA first determined the shortage was resolved ^[3][13]. After a voluntary reevaluation, the FDA reconfirmed on December 19, 2024 that the shortage was over ^[1][13]. Once a drug comes off the shortage list, federal law bars compounders from making “essentially copies” of it ^[13][14].

Why did Lilly go after compounded tirzepatide sellers?

Federal law allows compounding pharmacies to copy a shortage-listed drug only while the shortage lasts. The relevant statutes — 21 U.S.C. 353a(b)(1)(D) and 353b(a)(5) — prohibit making essentially copies of a commercially available or approved drug outside a shortage ^[13][14]. When the FDA confirmed the tirzepatide shortage was over, it said it would not take enforcement action for 60 or 90 days depending on the type of compounder, to allow an orderly transition ^[13]. New copies had to stop by mid-March 2025, though pharmacies could sell existing stock until it ran out or expired ^[1].

Lilly’s position is blunt. “Anyone continuing to sell mass compounded tirzepatide is breaking the law and deceiving patients,” the company said in a statement to NPR in April 2025 ^[1]. A Lilly spokesperson told WIRED there is “no basis for mass-producing or mass-marketing compounded tirzepatide, whether alone or mixed with other ingredients” ^[3].

The complaints Lilly filed against Strive, Empower and the four telehealth companies do not plead patent claims. What they plead is Lanham Act false advertising under 15 U.S.C. 1125(a)(1)(B), state deceptive trade practices and consumer protection statutes, and — against the telehealth companies — the unlawful corporate practice of medicine ^[5][11][12]. Mounjaro was approved in May 2022 and Zepbound in November 2023, and they are the only FDA-approved tirzepatide products, with Lilly’s exclusivity running to 2027 ^[13]. Lilly says it spent about $23 billion expanding manufacturing capacity during the shortage ^[13], and that developing tirzepatide took about a decade and 37 clinical trials ^[12].

What is the timeline of Lilly’s legal campaign?

Lilly started with suits against sellers and importers while the shortage was still on, then escalated sharply once it ended.

Date	Action	Source
September 2023	Lilly sues eight US companies over compounded Mounjaro	[17]
October 19, 2023	Lilly files ITC complaint against 11 online sellers, supplemented November 10, 2023	[2][15][17]
After October 2, 2024	Cease-and-desist letters to hundreds of pharmacies, telehealth firms and medspas	[3]
April 1, 2025	Suits against Strive Pharmacy (Delaware) and Empower Pharmacy (New Jersey)	[4]
April 23, 2025	Suits against Mochi Health, Fella Health and Delilah, Willow Health, Henry Meds	[1][5][8]
October 8, 2025	Strive case dismissed for lack of personal jurisdiction, without prejudice	[12]
January 14, 2026	Strive Specialties files antitrust suit against Lilly and Novo Nordisk	[14]
February 3, 2026	Lilly’s Lanham Act claim against Willow dismissed (C.D. Cal.)	[11]
April 29, 2026	Empower ruling issued (S.D. Tex.)	[11]
August 3, 2026	Strive antitrust suit dismissed	[14][18]
August 12, 2026	Lilly sues six US companies over purported retatrutide	[6]
August 27, 2026	Fifth Circuit affirms FDA’s delisting of tirzepatide	[13]
September 8, 2026	Mochi case trimmed for a third time	[7]

What happened in the ITC import case (337-TA-1377)?

Before suing the big compounders, Lilly went after importers. On October 19, 2023, it filed a complaint under section 337 of the Tariff Act of 1930 with the US International Trade Commission, alleging trademark infringement of Registration No. 6,809,369, false designation of source, and false and misleading advertising ^[2][15]. The investigation, numbered 337-TA-1377, was instituted on November 20-21, 2023 ^[2][15].

The 11 respondents included five US sellers (Arctic Peptides of Iowa, Strate Labs of Texas, Supopeptide and Unewlife of New Jersey, and Triggered Supplements of Florida) plus companies in Hong Kong, the United Kingdom, Poland, Spain and China ^[2][15]. The scope covered products containing or purporting to contain tirzepatide in powdered or constituted form ^[15]. Lilly described the products as “low-grade” versions and said testing showed one seller’s product was “nothing more than sugar alcohol” ^[17].

This is the clearest win in Lilly’s column. On January 28, 2025, the Commission declined to review an initial determination finding respondents in violation of section 337 ^[15]. On April 15, 2025, the Federal Register published notice that the Commission had issued a general exclusion order, a limited exclusion order and cease-and-desist orders, and had terminated the investigation ^[15]. ITC remedial orders are effective when issued and become final 60 days after issuance unless the US Trade Representative disapproves them ^[2].

What did Lilly accuse Strive and Empower of?

On April 1, 2025, Lilly sued two large compounding pharmacies, accusing both of marketing mass-produced products as if they were personalized, clinically tested, and made to stringent safety standards ^[4]. Strive and Empower supplied telehealth sites including Lavender Sky Health and Mochi Health ^[4].

Strive, based in Arizona, sells a combination of tirzepatide, vitamin B12 and glycine, and ships nationwide through partner providers ^[12]. Lilly argued Strive actually sells one form of the drug with no individual tailoring, and challenged Strive’s claims that its products are “safer and better” than those of “Big Pharma” and that it goes “above and beyond regulatory standards” ^[12]. Strive called the suit an example of “Big Pharma overstepping legitimate regulations” and said it would vigorously defend itself ^[4].

Empower — described in a case summary of the ruling as one of the largest compounding pharmacies in the country — was accused of selling standardized doses at massive scale, reportedly 70,000 doses per week, a figure attributed to Lilly’s complaint ^[11]. Empower said restricting personalized alternatives “is not in the best interest of patients” and that it is “committed to offering these life-changing formulations” ^[1][4]. Across the market, some compounders added ingredients like glycine, niacinamide and B vitamins to argue their products are not direct copies of Lilly’s ^[3][4].

What did Lilly accuse the four telehealth companies of?

On April 23, 2025, Lilly sued Mochi Health, Fella Health and Delilah, Willow Health and Henry Meds in federal court in California, accusing all four of deceiving consumers about “untested, unapproved drugs” ^[5][8]. Lilly’s theory was that a “personalized” label was covering mass-marketed, slightly altered versions of its drugs ^[8]. In all four cases, Lilly asked the courts to stop the sites from marketing or selling tirzepatide ^[8].

Against Mochi, Lilly alleged the company switched patients’ formulations and doses “at least five times in just eight months” and moved patients to lower doses that “have never been studied” ^[1][5]. Lilly also claimed Mochi CEO Myra Ahmad is not a licensed physician and that Mochi’s unlicensed owners control the prescribing decisions of physicians at its affiliated Mochi Medical, engaging in the unlawful corporate practice of medicine ^[5][8]. Ahmad responded that she holds a doctor of medicine degree but is not practicing as CEO, and Mochi said its model “remains compliant with FDA guidance and pharmacy regulations” ^[5][8].

Lilly made a similar corporate-practice claim against Fella Health and its affiliated Fella Medical Group, alleging Fella changed patients en masse from one formulation to another with additives, sells an oral version of tirzepatide, and told patients its untested oral drug is better than Lilly’s approved medicines ^[1][5]. Against Henry Meds, Lilly called its oral tirzepatide an “untested knockoff,” noting tirzepatide is approved only for under-the-skin injection and alleging Henry improperly referenced Lilly’s clinical trials on its website ^[1][5]. Against Willow, Lilly alleged the company falsely claimed to have developed the first “cosmetic” GLP-1, when the FDA has never approved tirzepatide for cosmetic weight loss ^[1].

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told NPR there is no bright line between the corporate practice of medicine and legitimate customization by a prescriber who has actually seen a patient ^[1].

Did Lilly win or lose the Strive case?

Lilly lost its first round against Strive, but on a technical ground. On October 8, 2025, Judge Stephanos Bibas, a Third Circuit judge sitting by designation in the District of Delaware (No. 1:25-cv-00401-SB), dismissed the case for lack of personal jurisdiction ^[12]. His opening line: “Our legal system rewards innovative drug development, not innovative jurisdictional theories” ^[12].

The problem was that Lilly challenged only Strive’s online statements, not its drug sales. Strive is licensed in Delaware and sells there through providers, but its ads were “not aimed anywhere but the World Wide Web,” and Lilly pleaded no facts connecting the statements to Delaware ^[12]. The court denied jurisdictional discovery and dismissed without prejudice, leaving Lilly free either to allege more jurisdictional facts or to sue Strive in Arizona ^[12].

What did the Empower and Willow rulings decide?

Lilly filed the Empower suit in New Jersey on April 1, 2025 ^[4]. A ruling in the Empower case later came in the Southern District of Texas, in Civil Action No. H-25-3464, where Senior Judge Sim Lake decided the motion to dismiss on April 29, 2026 ^[11]. The result was mixed. Applying the Supreme Court’s Lexmark framework, the court found Lilly’s allegations fell within the Lanham Act’s zone of interests, but failed the proximate causation prong: Lilly’s claim that “some sales” would have gone to Lilly was insufficient, and its theory that consumers might blame Lilly for harm from Empower’s products was too speculative ^[11].

The Willow case had already come out the same way. On February 3, 2026, the Central District of California dismissed Lilly’s Lanham Act claim against Willow on the same grounds ^[11]. A case summary of these rulings notes a pattern of judicial skepticism toward Lilly’s Lanham Act causation theories, joining an earlier decision in Eli Lilly v. Revive RX (S.D. Tex. 2025) ^[11].

But the state claims survived. The Empower court rejected Empower’s argument that federal law preempted Lilly’s state-law claims, finding the claims rest on independent state duties — prohibitions on selling unapproved new drugs — rather than enforcement of federal compounding rules, and following the Fifth Circuit’s 2025 decision in Zyla Life Sciences v. Wells Pharma ^[11]. State consumer protection claims under the laws of Alaska, Colorado, Connecticut, Hawaii, North Carolina, South Carolina, Tennessee and Washington all survived ^[11]. The court did dismiss a Texas common-law unfair competition claim, following its own Revive RX decision, and rejected Empower’s argument for a blanket exemption from state consumer law ^[11].

What has happened in the Mochi Health case?

The Mochi case has gone three rounds before Judge Jacqueline Scott Corley in the Northern District of California ^[7]. In 2025, she dismissed the suit, finding Lilly had failed to articulate how it was harmed ^[7]. In April 2026, she partially granted Mochi’s second dismissal motion, and Lilly’s state unfair competition claims went forward ^[7].

On September 8, 2026, in a third round on Lilly’s second amended complaint, she dismissed the Lanham Act conspiracy claims against the Mochi medical defendants and Aequita, but allowed California Unfair Competition Law conspiracy claims against Aequita Pharmacy and its parent Aequita Corporation to proceed ^[7]. Aequita is controlled by Abraham Chaibi, the husband of Mochi CEO Myra Ahmad, and the court found Ahmad had “significant control” over Aequita’s prescription-filling while Aequita had “significant financial motivation” to participate ^[7]. The corporate practice of medicine is prohibited in California ^[7]. The Lanham Act claims were dismissed without leave to amend unless discovery turns up supporting facts ^[7].

A Lilly spokesperson said the decision confirms Lilly can proceed on all three of its claims, and noted the company has obtained “more than a dozen permanent injunctions” against telehealth companies, medspas and mass compounders in other cases ^[7].

Can compounders get tirzepatide back on the shortage list?

They tried, and they lost. The Outsourcing Facilities Association and FarmaKeio Custom Compounding sued the FDA shortly after the October 2, 2024 delisting, in the Northern District of Texas (No. 4:24-CV-953), with Lilly intervening ^[3][13]. The group argued tirzepatide was still in short supply and that the delisting was “abruptly depriving patients” of needed treatment ^[3].

The district court denied their preliminary injunction, a Fifth Circuit panel upheld that denial, and the district court later entered summary judgment for the FDA and Lilly ^[13]. On August 27, 2026, in No. 25-10600, a per curiam panel of Judges Richman, Duncan and Oldham affirmed ^[13]. The court assumed without deciding that the FDA erred by skipping notice-and-comment procedures, but found no prejudice, and held the shortage determination was not arbitrary or capricious ^[13]. The FDA had treated the delisting as an informal adjudication under 5 U.S.C. 554(e) and concluded Lilly’s supply would “meet or exceed projected demand” ^[13]. The opinion was not designated for publication, and the companion Novo Nordisk semaglutide appeal was decided separately ^[13].

What was Strive’s antitrust countersuit about?

Strive fired back. On January 14, 2026, Strive Specialties sued Eli Lilly, Novo Nordisk A/S and Novo Nordisk Inc. in the Western District of Texas, San Antonio (No. 5:26-cv-00155-MA), amending the complaint on April 3, 2026 ^[14][18]. The claims were under sections 1 and 2 of the Sherman Act and section 3 of the Clayton Act ^[14].

Strive alleged that from late 2024 to early 2025, Lilly and Novo struck exclusive partnerships with telehealth providers that required dropping compounders; that telehealth accounts for about half of cash-pay GLP-1 prescriptions; and that compounders held about 10% of the cash market — figures that are Strive’s allegations as recited by the court, not findings ^[14]. Strive also pointed to Lilly’s launch of LillyDirect on January 4, 2024 and Novo’s NovoCare Pharmacy discounts ^[14]. Its complaint alleged US GLP-1 sales exceeded $40 billion in 2025 and branded prices exceed $1,000 per month — again, allegations, not findings ^[14].

On August 3, 2026, Judge Micaela Alvarez granted both drugmakers’ motions to dismiss ^[14][18]. She reasoned that compounded GLP-1s are available only when a physician finds the branded drug unsuitable for a patient, so they are not reasonably interchangeable and no plausible product market was alleged ^[18]. She also wrote that “antitrust laws protect competition — not individual competitors” ^[18]. Strive said it was disappointed and is evaluating an appeal, noting some state attorneys general had questioned the drugmakers’ efforts ^[18]. Lilly called it a “meritless claim” and Novo said it was “pleased” ^[18].

What about retatrutide?

On August 12, 2026, Lilly sued six US companies selling what they claim is retatrutide, Lilly’s investigational diabetes and weight loss drug, framing the sellers as a “black market” ^[6].

How much money is driving this fight?

The price gap explains the stakes. As of NPR’s April 2025 reporting, Zepbound’s list price was more than $1,086.37 per month while compounded tirzepatide sold for as little as $99 per month ^[1]. In late 2024, WIRED reported Lilly’s vial versions cost $400 to $550 per month depending on dose ^[3]. The Alliance for Pharmacy Compounding’s CEO estimated millions of people were taking compounded GLP-1s ^[3].

Figure	As of	Source
Zepbound list price: more than $1,086.37/month	April 2025	[1]
Compounded tirzepatide: as little as $99/month	April 2025	[1]
Lilly vials: $400-$550/month depending on dose	Late 2024	[3]
US GLP-1 sales above $40 billion in 2025	Strive’s allegation	[14]

What does all this mean for someone using compounded tirzepatide?

The defendants in these cases are companies — pharmacies, telehealth platforms, medspas and importers — not patients ^{[1][4][5][15]}. Mochi told CNBC in April 2025 it expected no interruption to patient care as a result of the suits against its suppliers ^[4]. Compounders may still make patient-specific versions with a doctor’s prescription, for example for someone allergic to a preservative in the branded product ^[1][4].

Two cautions are worth keeping in mind. First, the allegations in Lilly’s complaints are just allegations; the rulings so far are mostly at the motion-to-dismiss stage, where courts assume the plaintiff’s facts are true and decide only whether the case can proceed ^[7][11][12]. Second, access has cut both ways: at an October 2024 roundtable, four pharmacists said they were still having trouble obtaining brand-name tirzepatide right after the delisting ^[3]. Nothing here is legal advice — it explains the litigation only.

Sources

1. NPR. Eli Lilly sues companies selling alternative versions of its weight loss drug. April 23, 2025.
2. United States International Trade Commission. USITC Institutes Section 337 Investigation of Certain Products Containing Tirzepatide and Products Purporting to Contain Tirzepatide. November 21, 2023.
3. WIRED. The Crackdown on Compounded GLP-1 Meds Has Begun.
4. CNBC. Eli Lilly sues two pharmacies making copycat Zepbound, Mounjaro. April 1, 2025.
5. The Hill. Eli Lilly sues telehealth companies selling compounded Zepbound, Mounjaro.
6. Endpoints News. Eli Lilly files first lawsuits over retatrutide ‘black market’. August 12, 2026.
7. Courthouse News Service. Eli Lilly lawsuit against weight-loss drug seller gets another shave.
8. CNBC. Eli Lilly sues four telehealth sites selling compounded Zepbound, Mounjaro. April 23, 2025.
9. Endpoints News. Eli Lilly sues four telehealth companies selling compounded tirzepatide. April 23, 2025.
10. Law.com Texas Lawyer. Eli Lilly Files Slew of Lawsuits Over Zepbound and Mounjaro. April 25, 2025.
11. LexSummary. Eli Lilly v. Empower Clinic Services — Court Dismisses Lanham Act Claim Against Compounding Pharmacy but Allows State Consumer Protection Claims to Proceed. April 29, 2026.
12. US District Court for the District of Delaware. Eli Lilly & Co. v. Strive Pharmacy LLC, memorandum opinion. October 8, 2025.
13. US Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. Food and Drug Administration, unpublished opinion. August 27, 2026.
14. US District Court for the Western District of Texas. Strive Specialties Inc. v. Eli Lilly & Co., Novo Nordisk A/S, and Novo Nordisk Inc., opinion and order. August 3, 2026.
15. Federal Register. Certain Products Containing Tirzepatide and Products Purporting To Contain Tirzepatide; Notice of Institution of Investigation. November 27, 2023.
16. Federal Register. Certain Products Containing Tirzepatide and Products Purporting To Contain Tirzepatide; Notice of Investigation. April 15, 2025.
17. Fierce Pharma. Eli Lilly goes after 11 online pharmacies for allegedly selling unauthorized versions of Mounjaro. October 20, 2023.
18. Reuters. Lilly, Novo defeat antitrust lawsuit over GLP-1 drug market. August 6, 2026.