Eli Lilly sues Strive and Empower over compounded tirzepatide

Eli Lilly is suing two pharmacies for compounding Zepbound and Mounjaro, claiming the businesses are skirting the Food and Drug Administration’s ban on the practice and luring people away from Lilly’s medicines.

In lawsuits filed Tuesday in Delaware and Latest Jersey, Lilly alleges the 2 corporations — Strive Pharmacy and Empower Pharmacy — are falsely marketing their products as personalized versions of the drugs which were clinically tested and are made using stringent safety standards. Lilly argues these claims are turning people toward compounded drugs and away from its FDA-approved treatments.

Empower in an announcement said restricting access to personalized alternatives to business drugs shouldn’t be in the most effective interest of patients, and it’s “committed to offering these life-changing formulations.” Strive called Lilly’s lawsuit a classic example of Big Pharma overstepping legitimate regulations to prioritize its own interests and said it’ll vigorously defend its position.

Compounding pharmacies and outsourcing facilities were largely imagined to stop making their very own versions of tirzepatide, the energetic ingredient in Lilly’s weight-loss drug Zepbound and diabetes treatment Mounjaro, last month after the FDA determined the branded versions were now not in shortage. Some continued compounding, tweaking the dosages and mixing them with vitamins, distinctions that make them different from Lilly’s drugs and potentially allow them to skirt the FDA’s ban.

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

Strive and Empower supply tirzepatide to popular telehealth sites, including Lavender Sky Health and Mochi Health. In an announcement, Mochi said it doesn’t anticipate any interruptions or delays in patient care because of this of this lawsuit, and that it stays confident within the integrity of its clinical approach. Lavender Sky Health didn’t reply to a request for comment.

We remain committed to providing secure, evidence-based treatments that prioritize their health and well-being above all else. We don’t anticipate any interruptions or delays in patient care because of this of this lawsuit and remain confident within the integrity of our clinical approach.

These lawsuits shall be the primary test of Lilly’s ability to tackle compounding pharmacies in court now that Zepbound and Mounjaro are off the FDA’s shortage list. They usually could provide a roadmap for Novo Nordisk, whose obesity drug Wegovy and diabetes treatment Ozempic generally cannot be compounded after the top of May.