Eli Lilly sues Strive and Empower as FDA lifts tirzepatide shortage status

Eli Lilly is escalating its legal push to protect the exclusivity of its high-profile weight-loss and diabetes drugs, Zepbound and Mounjaro, by suing two compounding pharmacies — Strive Pharmacy and Empower Pharmacy — over their continued production of altered tirzepatide formulations.

Filed on Tuesday in Delaware and New Jersey, the lawsuits mark Lilly’s first legal move since the US Food and Drug Administration (FDA) removed the drugs from its shortage list, a change that effectively limits the conditions under which compounding is allowed.

The pharmaceutical giant alleges that both pharmacies are violating federal drug laws by mass-producing non-approved versions of tirzepatide, the active ingredient in its FDA-approved treatments, under the guise of personalised care.

FDA shortage list ends

Lilly’s lawsuits argue that Strive and Empower are “falsely marketing” their compounded tirzepatide products as personalised alternatives that meet clinical safety standards.

According to court filings, the pharmacies supply these drugs to telehealth companies such as Lavender Sky Health and Mochi Health.

The legal claims come after the FDA officially removed Zepbound and Mounjaro from its shortage list, meaning compounders must stop producing versions unless under specific, narrow circumstances — for instance, when a patient is allergic to an ingredient in the branded drug or cannot consume the standard form.

Previously, compounding was permitted due to supply limitations.

Despite the end of that allowance, Lilly claims the pharmacies are continuing to make and sell these modified formulations by altering doses and mixing in other substances, such as vitamins, to create technical differences.

Lilly maintains that these are not true personalised medicines but mass-manufactured alternatives that undercut its regulated offerings.

Compounding rules tightened

Under US law, compounding pharmacies can make custom drugs in limited cases.

However, once a branded drug is no longer in short supply, large-scale production is prohibited unless explicitly authorised.

The FDA’s updated position on tirzepatide tightened those rules, placing increased scrutiny on compounded versions of the drug.

Lilly’s argument is that Strive and Empower are exploiting grey areas in the regulation by continuing to produce what it describes as unauthorised variations of Zepbound and Mounjaro.

These compounded products may not adhere to the same safety and efficacy standards, yet are being marketed in a way that suggests they are equivalent or superior.

The case could set a precedent

This case could become a blueprint for other pharmaceutical companies seeking to defend their patent-protected drugs from what they view as unauthorised replication.

Novo Nordisk, the maker of Wegovy and Ozempic, may soon face a similar challenge, as compounded versions of its own obesity and diabetes drugs are also expected to become non-compliant following the end of the FDA’s temporary allowances.

Lilly’s success or failure in this legal action could shape the future of how branded drug makers deal with compounding pharmacies, particularly in the context of growing demand for GLP-1 receptor agonists like tirzepatide.

These drugs are seeing surging popularity for weight-loss use, placing pressure on supply chains and leading some healthcare providers to source alternatives through compounding channels.

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