Lilly moves to join lawsuit over compounded copies of Zepbound and Mounjaro

Eli Lilly has asked a federal court in Fort Worth, Texas, for permission to join a lawsuit that will help decide whether compounding pharmacies and facilities can keep selling cheaper, unapproved copies of its tirzepatide drugs, Zepbound and Mounjaro ^[1]. The company filed its motion late Wednesday ^[1].

The lawsuit was brought by the Outsourcing Facilities Association, a compounding industry group, along with a Texas compounding pharmacy ^[1]. It challenges the Food and Drug Administration's decision, first made in October, that tirzepatide is no longer in short supply ^[1]. Compounded copies of a brand-name medicine can generally be made in significant amounts only while the original is on the FDA's shortage list ^[1].

After the lawsuit was filed, the FDA agreed to reconsider its decision. On Dec. 19, the agency affirmed that there is no shortage and said it would not take enforcement action for at least 60 days ^[1]. The compounding industry is still asking a court to reverse that finding ^[1].

Lilly told the court it needed to join the case because it cannot be sure the FDA will fully defend its interests, including whether the agency would appeal if the court ruled against it ^[1]. The FDA declined to comment, and the Outsourcing Facilities Association did not immediately respond to requests for comment ^[1].

Lilly also took a position that may differ from the FDA's. The company said it believes compounding pharmacies, as opposed to larger so-called outsourcing facilities, may not manufacture compounded drugs even when there is a shortage ^[1].

Not every GLP-1 medicine has left the shortage list. Novo Nordisk's Wegovy, which contains semaglutide, remains on the FDA's shortage list ^[1]. The Alliance for Pharmacy Compounding, another industry group, said in November that a survey showed more than 200,000 prescriptions a month were being filled for compounded versions of Wegovy ^[1].

Insurers generally cover Lilly's and Novo Nordisk's drugs when they are prescribed for diabetes, but many do not cover the weight-loss versions, which has led many patients to pay out of pocket for compounded copies that are typically cheaper ^[1]. Lilly began sending cease-and-desist letters in August to telehealth companies, wellness centers and medical spas selling compounded Zepbound and Mounjaro, and it has filed lawsuits against sellers falsely claiming to offer FDA-approved versions of the drug ^[1].

Why it matters for patients

The compounded products at issue are essentially copies of the branded medicines but are not approved by the FDA ^[1]. Their large-scale availability is tied to shortage status: if the FDA's finding that tirzepatide is no longer in short supply stands, that supply could narrow or stop. If a court reverses the agency, compounded tirzepatide could remain available ^[1].

Cost is the other practical factor. Compounded versions are typically cheaper than the brand-name drugs, and many insurance plans do not cover weight-loss medications at all, so some patients have turned to compounded products to pay less ^[1].

What the judge will decide, and how quickly, has not been reported. It also has not been disclosed whether the FDA would appeal a ruling against it, which is one reason Lilly gave for wanting to join the case ^[1]. Lilly's motion did not set out what it would ask the court to do if allowed in ^[1].

What happens next

The FDA said on Dec. 19 that it would not take enforcement action for at least 60 days, a window that runs into mid-February ^[1]. The compounding industry is seeking a court order reversing the shortage finding, and no date for a ruling has been announced ^[1]. Lilly's request to join the case was filed Jan. 1, and the court has not ruled on it in the reporting on the filing ^[1].