Over the past year, Eli Lilly and Novo Nordisk have aggressively expanded their legal playbook to combat what they allege is the unauthorized marketing and sale of compounded versions of their blockbuster GLP-1 drugs, tirzepatide (Mounjaro) and semaglutide (Ozempic, Wegovy). While earlier lawsuits focused primarily on brick-and-mortar pharmacies, weight-loss clinics, and med spas, the newest wave targets a more tech-forward sector—telemedicine companies and digital health platforms.
This evolution marks a strategic shift and serves as a warning shot for the broader healthcare ecosystem. Both traditional and tech-enabled providers now face heightened legal risk when offering alternatives to branded GLP-1 medications, especially in the wake of the FDA declaring the end of drug shortages for semaglutide and tirzepatide.
The New Frontier: Lawsuits Against Telehealth Companies
In recent months, Eli Lilly filed lawsuits against several telehealth and digital health companies offering compounded tirzepatide products through online platforms. These companies—some of which were venture-backed, physician-operated, or serving niche patient populations—are accused of violating the Federal Food, Drug, and Cosmetic Act (FDCA), engaging in false advertising, and intentionally misleading consumers into believing that their compounded versions are FDA-approved or equivalent to the brand-name drug.
What's particularly notable in this new batch of lawsuits is
the added focus on deceptive marketing and
formulation modifications. Lilly has alleged that
certain telemedicine companies intentionally altered compounded
tirzepatide products—adding vitamins, amino acids, or other
substances—not for therapeutic value, but in an attempt to
evade legal claims that the products were "essentially
copies" of the commercially available drug. The strategy, the
lawsuits argue, is a veiled workaround that undermines federal law
and puts patients at risk.
These allegations go beyond traditional "patent
infringement" theories or the compounder's defense of
medical necessity. Instead, they strike at the core of business
models that have become common in digital health: rapid
scalability, automation of prescribing, and consumer-friendly
marketing.
Contrast With Early Lawsuits: Pharmacies and Med
Spas
This contrasts with the first wave of lawsuits
that began in late 2023 and early 2024. Those earlier suits were
generally more straightforward. Branded manufacturers alleged that
compounding pharmacies and weight-loss clinics were violating
certain laws and misusing trademarks, particularly when unbranded
compounders and med spas used the terms "Ozempic,"
"Wegovy," or "Mounjaro" in marketing materials
or other contexts. There was also a focus on the quality of the
products including API being used by these entities.
The more recent batch of lawsuits include different claims and also carry one key distinction—the FDA has now declared the shortage as over whereas the prior cases came at a time when there was no dispute compounding of tirzepatide and semaglutide was permissible under FDA guidelines.
Key Legal Trends Across the Lawsuits
Despite differences in defendants and business models, several common threads emerge from these lawsuits:
Post-Shortage Enforcement
With semaglutide and tirzepatide officially removed from the FDA's shortage list, the legal shield under Section 503A has effectively disappeared—yet many compounders and providers have continued to produce and dispense these drugs. Both Eli Lilly and Novo Nordisk are seizing this moment to crack down hard on what they view as open defiance of FDA policy.
Heightened Scrutiny of Customization Claims
The lawsuits are increasingly skeptical of providers' justifications that their compounded formulations are "customized" for patient needs. Minor ingredient tweaks—especially when applied uniformly across patients—are being called out as pretextual and commercially motivated.
Expansion to Digital Health
By naming telemedicine companies in recent lawsuits, the manufacturers are signaling that digital scale is not a defense. The argument that telehealth "broadens access" is being rejected where the companies are seen as automating prescribing, marketing unapproved drugs, and bypassing the rigorous standards applied to traditional pharmacies.
Consumer Protection Theories
Beyond FDA law, rules, and regulations, several lawsuits now
allege false advertising, fraud,
and consumer deception—which opens the door
to broader remedies, including injunctive relief and damages under
state consumer protection statutes.
Implications for Pharmacies and Telehealth
Providers
These developments aren't isolated to a few "bad
actors." They reflect a broader strategy by manufacturers to
pressure the entire supply chain—pharmacies, prescribers,
telehealth platforms, marketers, and even payment
processors—to back away from compounded GLP-1
offerings.
If you're a pharmacy or a telehealth provider offering or
considering compounded semaglutide or tirzepatide products, you
must confront the following:
Know the Regulatory Limits
Any compounded medication must comply with FDA regulations under Section 503A or 503B. For 503A pharmacies, the patient-specific prescription requirement must be rigorously followed, and compounding cannot occur if the drug is "commercially available" unless a prescriber certifies a clinical difference. For 503Bs, outsourcing facility registration and cGMP compliance are non-negotiable.
Know Your Marketing and Avoid Risky Marketing Practices
Do not use brand names in advertising or suggest that compounded alternatives are "the same" or "bioequivalent." If your products are not FDA-approved, clearly state that—and avoid any implication to the contrary.
Customize With Caution
Simply adding vitamin B12 or amino acids to a compounded GLP-1 product is not a legal shield if it is done uniformly and lacks clinical justification. The courts are beginning to see through these tactics.
Evaluate Prescribing and Dispensing Models
If you are using automated telehealth platforms or asynchronous prescribing models, consider how those systems align with the standard of care and informed consent obligations. The plaintiffs in recent lawsuits are alleging not only FDA violations but medical negligence and patient deception.
Review Liability Exposure
You may be at risk of being swept into litigation not only for manufacturing or dispensing, but for aiding and abetting, consumer fraud, or unfair competition. Plaintiffs are casting a wide net—including marketers, influencers, and platform operators.
Where the Industry Goes From Here
This litigation push is just the beginning. Plaintiffs are
learning from one another. The same plaintiff-side counsel bringing
cases against traditional pharmacies are now suing telemedicine
startups. Meanwhile, manufacturers are cooperating with regulatory
agencies and testing products purchased through online
platforms.
For pharmacies, the key is not to operate in fear—but in
preparation. There is still a lawful, clinically sound role for
compounded medications. But that role requires compliance,
documentation, and transparent communication. For telehealth
companies, the stakes are higher—regulators are watching, and
venture funding doesn't insulate a company from liability.
Conclusion: Time to Act
If you're a pharmacy or telehealth provider in the GLP-1 space, now is the time to reassess your legal risk. These lawsuits are not going away. The scrutiny is intensifying. But with the right legal and operational guardrails and tools, you can continue to serve patients, innovate care models, and protect your business from avoidable litigation.
We work with pharmacies, prescribers, and digital health companies across the country to navigate GLP-1 regulatory issues, respond to cease and desist letters, and proactively audit compounding and marketing practices.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
