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Wednesday, April 23, 2025

Lilly Sues 4 GLP-1 Telehealth Startups, Escalating War on Knockoff Drugs



On Wednesday, pharmaceutical giant Eli Lilly sued four prominent telehealth companies that offer more affordable, off-brand versions of its patented best-selling GLP-1 medications Mounjaro and Zepbound. Together, the drugs accounted for over $16.4 billion in revenue for the company last year. It’s the latest escalation in an ongoing war between the drug industry and health care providers over what are widely seen as the most effective—and lucrative—drugs for treating obesity and diabetes to come on the market in years.

The lawsuits target four telehealth brands, Mochi Health, Fella & Delilah Health, Willow Health, and Henry Meds. Eli Lilly alleges that each company is selling illegal knockoffs of its drugs, in some cases, with untested added ingredients like vitamins and amino acids in an attempt to distinguish them from its name-brand medications.


None of the companies named as defendants immediately responded to requests for comment from WIRED about the lawsuits. In response to general questions about its business practices, Mochi Health said in a statement that it offers compounded GLP-1 medications that are “customized for medical necessity."


“Their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider—not as mass-market substitutes for branded medications,” Mochi Health said. Fella & Delilah Health, Willow Health, and Henry Meds did not respond to questions about its business practices in time for publication.

Lilly previously filed other lawsuits against more than a dozen compounding pharmacies, medical spas, and wellness centers for selling drugs claiming to contain tirzepatide, the active ingredient in both Zepbound and Mounjaro.



Mounjaro surged in popularity after it was approved to treat diabetes in May 2022, and the FDA declared some doses of it were in shortage by the end of that year. Zepbound was approved as an obesity treatment in November 2023, with certain doses going into short supply months later. (Novo Nordisk’s competing GLP-1 medications, Ozempic and Wegovy, also went into shortage in 2022.)


When there’s an official shortage of a drug, compounding pharmacies are legally allowed to create duplicate copies or custom-mixed approximations known as “compounds” to meet patient needs. These off-brand versions are not approved by the FDA—but they are often far more affordable than name-brand medications.

During the years-long tirzepatide and semaglutide shortages, which the FDA officially declared over in December and February, compounded GLP-1s became widely available through existing telehealth providers and startups that sprang up specifically to cash in on the new, lucrative health care niche. According to a trade group representing compounders, at least 2 million people in the US were taking these medications as of November last year.

Some telehealth companies offered vials of tirzepatide for under $100, a fraction of the cost of Mounjaro and Zepbound, and shipped them to patients within days after they filled out a quick online questionnaire.

While most telehealth brands and compounding pharmacies do not disclose their revenue, industry juggernaut Hims said during a recent earnings call that it brought in about $225 million from GLP-1 drug sales last year. (Hims no longer sells compounded tirzepatide, but recently added branded Zepbound to its offerings.)

Lilly’s lawsuit against Willow Health Services alleges that the Texas-based telehealth company falsely markets some of its products, such as an oral droplet GLP-1 drug and a version of compounded tirzepatide with added niacinamide added, as “custom-prepared” for patients despite being mass-produced.

Some companies selling compounded GLP-1 meds are unlikely to stop without a fight. A compounding trade group has filed a set of lawsuits against the FDA on behalf of clients, arguing that the agency prematurely declared the GLP-1 shortages over. Whether or not their legal efforts are successful, there’s still a possibility that the drugs could once again go into shortage if demand continues to rise. As new research continues to point to additional medical uses for these drugs, that may very well happen.

“Pharmacies compound medication all the time, and there are no lawsuits about it because they’re not trying to compete with drug companies,” Lambert says. “This is so contentious because there’s so much money at stake.”

https://www.wired.com/story/glp-1-compounding-fda-lawsuits/

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