'Deceptive' Practices? Eli Lilly Sues Telehealth Firms Over Zepbound Knockoffs
- Jennifer Hardy
- 5 days ago
- 6 min read
SAN FRANCISCO (April 23, 2025) Eli Lilly, the pharmaceutical giant, filed a sweeping set of lawsuits in federal court, accusing four telehealth startups—Mochi Health, Fella Health, Empower Pharmacy, and Henry Meds—of illegally selling off-brand, compounded versions of its blockbuster weight-loss and diabetes drugs, Zepbound and Mounjaro.
According to the complaints, these companies are marketing “untested, unapproved” versions of tirzepatide, the active ingredient in Lilly’s FDA-approved medications, without proper oversight, safety data, or regulatory clearance. Some are even selling oral pills and under-the-tongue tablets—forms the FDA has never approved.
It's the latest step in the controversy over patient safety, patents, and profits in the exploding market for compounded GLP-1 drugs.
Who’s in the Crosshairs of the Eli Lilly Lawsuit?
We've told you about previous lawsuits between Big Pharma and compounding pharmacies in the burgeoning GLP-1 marketplace, but this one targets some of the most visible—and heavily marketed—telehealth startups selling compounded versions of weight-loss drugs like Zepbound and Mounjaro.
“[The telehealth companies] are deceptively marketing knockoff tirzepatide as safe and effective for ‘cosmetic weight loss’, improperly practising medicine or influencing medical decisions, and falsely claiming to sell ‘personalised’ compounded tirzepatide.” - Eli Lilly Spokesperson to Pharmaceutical Technology
Let's look at the lawsuits one by one.
Eli Lilly vs. Mochi Health
Lilly accuses Mochi Health and affiliated entities of running a “conspiracy and enterprise” to sell untested, compounded tirzepatide with additives like niacinamide, glycine, and pyridoxine.
The complaint alleges false advertising, improper medical practice, and unsafe mass prescription changes driven by business interests—not medical necessity. Mochi's founder, Myra Ahmad, is also called out for misrepresenting her medical credentials.
Allegations include, "Over the span of just eight months, Mochi Health switched dosages and prescriptions for patients en masse at least five times—with corporate interests, rather than doctor decision-making—driving the changes."
Download the Eli Lilly and Company v Mochi Health Corp. (et al) Lawsuit
Eli Lilly vs. Empower Pharmacy
Empower Pharmacy is being sued over its compounded tirzepatide/niacinamide injections and a new untested oral version, marketed as “Tirzepatide ODT.” Lilly claims these are mass-produced without proper clinical trials and misrepresented as safe, effective, and personalized.
The lawsuit states, in part, "By selling Tirzepatide ODT, Empower is essentially conducting a
mass testing experiment on consumers: testing its oral tirzepatide on the general population now, without obtaining any informed consent and without the safety controls of a proper clinical trial."
The lawsuit points out that Empower’s facilities have previously been flagged for regulatory issues, including unsanitary conditions and concealing violations.
Download the Eli Lilly and Company v Empower Clinic Services LLC (et al) Lawsuit
Eli Lilly vs. Aios Inc. (Fella Health and Delilah)
This suit targets Fella Health and its female-facing counterpart, Delilah, accusing them of distributing both oral tirzepatide and versions mixed with glycine or l-arginine—none of which are FDA-approved or clinically tested.
The complaint also alleges unlawful control of medical practices by non-doctors and deceptive marketing that piggybacks off Lilly’s clinical data.
Part of the suit claims, "For instance, when a patient complained that Fella’s untested knockoff drug was not working, Cartwright told the patient to take more of the knockoff drug faster, instructing the patient, 'we’ll just escalate your titration speed to ensure no wasted time.' Fella also makes sweeping corporate decisions that dictate patient care, such as when Fella changed patients en masse from one tirzepatide formulation to another with additives."
Download the Eli Lilly and Company v Aios Inc. (et al) Lawsuit
Eli Lilly vs. Adonis Health (Henry Meds)
Lilly alleges Henry Meds markets compounded tirzepatide and “Compounded Oral Tirzepatide” as safe and effective, misleadingly invoking Lilly’s brands. The suit points out that Henry’s products are not “patient-specific” as advertised but mass-produced. Lilly also highlights the lack of clinical data to support safety or efficacy claims for these formulations.
Part of the suit states, "Henry’s deceptive business practices and false marketing claims trade on the goodwill of safe and effective FDA-approved drugs in favor of Henry’s untested and unapproved products—all under false pretenses and to the detriment of patients."
Download the Eli Lilly and Company v Adonis Health Inc. (et al) Lawsuit
As of the eve of the lawsuit filing, no defendants have responded to requests for comment.
MORE: The path to Oral GLP-1s
How GLP-1s Got Us to This Litigious Point
Tirzepatide demand exploded after Mounjaro and Zepbound hit the market in 2022 and 2023. Shortages followed, and with them, a legal gray area: U.S. regulations allow compounding pharmacies to produce alternative versions of drugs during FDA-declared shortages.
Startups and compounders jumped in, offering “Zepbound alternatives” at a fraction of the retail cost. But the FDA officially declared the shortage over in late 2024. That shut the legal door on mass production.
According to Lilly, some companies kept compounding anyway—betting the demand and confusion would shield them. Some believe that stopping the compounding would lead to millions of people being without medication. These lawsuits are the company’s response.
The court of law is much different than the court of public opinion. An estimated 2 million Americans had used these alternatives by the end of 2024, many drawn by convenience, price, and access—not clinical trial data.
It doesn't help that insurance companies generally don't cover weight loss medication, and the price tag for GLP-1s without insurance can reach $1,400 a month.
So, What Should Customers of Compounded Tirzepatide Do?
It starts with being educated about what you're putting into your body.
If you’ve been prescribed a compounded version of tirzepatide—or you’re considering one—it’s time to press pause and check in with your healthcare provider. These lawsuits aren’t just courtroom drama; they raise serious questions about safety, oversight, and consistency in a fast-moving, lightly regulated market.
Compounded tirzepatide is not FDA-approved, and it often contains unverified additives such as niacinamide, glycine, or pyridoxine. That doesn’t mean it’s automatically unsafe—but it does mean no federal agency has reviewed it for safety or effectiveness. Even the FDA stated this.
Here are a few practical steps patients should consider:
Consult your doctor. If you’re using compounded GLP-1s, bring it up at your next visit. Ask whether your dose and formulation are appropriate, especially if you’ve switched to a different version or provider without explanation.
Know your source. Not all compounding pharmacies operate the same way. Ask whether yours is 503A (traditional pharmacy) or 503B (outsourcing facility), and whether it’s following federal guidelines—including the requirement that compounded drugs be tailored to individual patients, not mass-produced.
Know the laws. If a telehealth company markets tirzepatide as “just like Zepbound” or promises results based on Lilly’s clinical trials, that’s a red flag. Compounded drugs cannot legally be sold as equivalents to FDA-approved medications, and mass marketing language like “same results, lower cost” or "generic Zepbound" may signal misleading—or even unlawful—claims.
Watch for side effects. Hypoglycemia, nausea, kidney strain, and allergic reactions can all be signs that something’s off with the formulation, but some can also be GLP-1 side effects with the legit versions. Track and report any changes, even subtle ones.
Should you switch to the name-brand? If cost or access isn’t a barrier, FDA-approved options like Zepbound® or Mounjaro® offer a clearer safety profile and more predictable results. That said, Eli Lilly isn't going after customers.
Also, both Eli Lilly and Novo Nordisk have started lower-cost options. For example, Lilly Direct offers vials and supplies starting at $349 with the 10mg dose at $499.
DID YOU KNOW? Compounded medications and generic medications aren't the same thing. Compounded medications are custom-made for individual patients, often when a specific dose or ingredient change is needed. Generic medications are FDA-approved copies of brand-name drugs with the same active ingredients, dosage, and safety profile. Until the patents expire on tirzepatide and semaglutide, we won't have generic GLP-1s.
What’s Next in the Compounding Controversy
Lilly is seeking injunctions to immediately halt the sale and marketing of compounded tirzepatide by all four companies. The odds of that happening? Slim to none. These legal cases can go on for years. Even with FDA warnings, some compounding facilities aren't flinching.
Another chess move is when Big Pharma companies try to list their medications as "Demonstrably Difficult to Compound (DTC)." That requires a process with the FDA, a step Eli Lilly is working through with tirzepatide.
Future decisions could change the relationship between compounding and Big Pharma for years to come.
コメント