Eli Lilly Sues Strive and Empower over Compounded Tirzepatide

Lilly Sues Pharmacies for Compounding Zepbound and Mounjaro

Lawsuit Claims Pharmacies are Skirting FDA Ban and Luring Patients Away from FDA-Approved Treatments

Eli Lilly is suing two pharmacies, Strive Pharmacy and Empower Pharmacy, for compounding Zepbound and Mounjaro, claiming that the companies are falsely marketing their products as personalized versions of the drugs. The lawsuit alleges that these claims are turning people towards compounded drugs and away from Lilly’s FDA-approved treatments.

Background on Compounding Pharmacies and FDA Regulations

Compounding pharmacies and outsourcing facilities were largely supposed to stop making their own versions of tirzepatide, the active ingredient in Lilly’s weight-loss drug Zepbound and diabetes treatment Mounjaro, last month after the FDA determined the branded versions were no longer in shortage. Some continued compounding, tweaking the dosages and combining them with vitamins, distinctions that make them different from Lilly’s drugs and potentially allow them to skirt the FDA’s ban.

Lilly’s Allegations

Lilly argues that Strive and Empower are merely mass producing altered versions of tirzepatide rather than personalizing them. Branded drugs are allowed to be compounded at large scale when they’re in shortage. Outside of that, custom versions can be made for unique situations, like if a person is allergic to an ingredient or can’t take the form of the drug it’s normally sold in.

Reactions from Pharmacies and Telehealth Sites

Strive and Empower have responded to the lawsuit, with Strive calling Lilly’s lawsuit a classic example of Big Pharma overstepping legitimate regulations to prioritize its own interests. Empower, on the other hand, stated that restricting access to personalized alternatives to commercial drugs is not in the best interest of patients. Telehealth sites like Mochi Health and Lavender Sky Health have also issued statements, with Mochi expressing confidence in the integrity of its clinical approach and Lavender Sky Health not responding to a request for comment.

Conclusion

This lawsuit will be the first test of Lilly’s ability to take on compounding pharmacies in court now that Zepbound and Mounjaro are off the FDA’s shortage list. The outcome of this case will provide a roadmap for other pharmaceutical companies, such as Novo Nordisk, whose drugs can also be compounded after the end of May.

FAQs

Q: What is compounding?
A: Compounding is the process of customizing a drug to meet an individual patient’s needs.

Q: Why is Lilly suing Strive and Empower?
A: Lilly is suing Strive and Empower for allegedly skirting the FDA’s ban on compounding and luring patients away from FDA-approved treatments.

Q: What is the FDA’s stance on compounding?
A: The FDA has determined that branded versions of tirzepatide are no longer in shortage, and therefore, compounding pharmacies and outsourcing facilities are no longer allowed to make their own versions of the drug.