Eli Lilly Takes Legal Action Against Four Telehealth Startups Over GLP-1 Drug Copies

Pharmaceutical company Eli Lilly has initiated legal proceedings against four telehealth companies that provide alternative, non-branded versions of its successful GLP-1 medications, Mounjaro and Zepbound. These drugs were significant contributors to Eli Lilly's revenue, generating over $16.4 billion in the previous year. This lawsuit marks the latest development in an ongoing conflict between the pharmaceutical industry and healthcare providers concerning what are considered the most effective treatments for obesity and diabetes in recent years.

The companies targeted in the lawsuit include Mochi Health, Fella & Delilah Health, Willow Health, and Henry Meds. Eli Lilly accuses these firms of selling unauthorized replicas of its medications, often incorporating unverified additional ingredients, such as vitamins and amino acids, to differentiate their products from Lilly's.

As of now, none of the defendants have publicly commented on the lawsuits. However, Mochi Health issued a statement defending its practices, asserting that it provides compounded GLP-1 medications tailored for medical necessities, which can be legally prescribed by licensed providers. The other companies, Fella & Delilah Health, Willow Health, and Henry Meds, did not respond to inquiries by the time of publication.

This is not Eli Lilly's first foray into legal action against entities involved in the production and distribution of compounded medications. The company has previously filed lawsuits against various compounding pharmacies and wellness centers that marketed products claiming to contain tirzepatide, the active ingredient in both Zepbound and Mounjaro.

Mounjaro gained significant traction after receiving FDA approval for diabetes treatment in May 2022, which subsequently led to a reported shortage of certain dosages by the end of that year. Zepbound, approved for obesity treatment in November 2023, faced similar supply issues shortly thereafter. Competing drugs from Novo Nordisk, such as Ozempic and Wegovy, also experienced shortages in 2022.

During official drug shortages, compounding pharmacies are legally permitted to create duplicate versions or custom formulations to meet patient requirements. Although these alternative medications lack FDA approval, they often provide a more affordable option compared to the branded counterparts. As of November last year, a trade group indicated that approximately 2 million individuals in the U.S. were using these compounded GLP-1 medications.

Some telehealth providers offered tirzepatide vials for under $100, significantly less than the retail price of Mounjaro and Zepbound, and expedited shipping was available after patients completed an online questionnaire.

While many compounding pharmacies and telehealth providers have ceased production and sales following the end of the shortage, a number continue to offer tirzepatide with added ingredients or in unapproved dosages. Experts suggest that the companies still marketing these products are attempting to justify their practices by claiming that the additions render the medications unique.

The crux of Eli Lilly's allegations rests on the premise that the medications sold by these telehealth companies are not genuinely personalized, as they are mass-produced and marketed to multiple patients. The company asserts that there are instances where compounding can be beneficial, such as for patients with specific allergies or those requiring precise dosing adjustments. However, Eli Lilly argues that the current practices of these telehealth firms do not align with these standards.

In its legal action against Mochi Health, Eli Lilly claims that the company altered dosages and prescriptions for patients based on corporate directives rather than clinical judgment. Additionally, the lawsuit points out that Mochi's formulations included niacinamide and pyridoxine, both B vitamins, which the pharmaceutical company contends lack adequate safety and efficacy data when combined with tirzepatide.

In a related case, Eli Lilly alleges that Fella & Delilah Health transitioned all its patients from a simple compounded tirzepatide product to a version with untested amino acid additives. The lawsuit against Henry Meds claims the company misrepresents clinical trial data regarding its products, while the action against Willow Health Services contends that it falsely promotes certain offerings as custom-prepared when they are actually produced in bulk.

Some telehealth companies may resist halting their operations without legal disputes. A trade group representing compounding pharmacies has filed lawsuits against the FDA, contending that the agency prematurely declared the shortages resolved. Despite potential legal outcomes, the risk of renewed shortages remains if demand continues to escalate as new research highlights additional therapeutic applications for these medications.

Compounding pharmacies typically create custom medications for individual patient needs, and the current situation is contentious due to the substantial financial implications at stake.