Eli Lilly Intervenes in Lawsuit to Block Compounded Versions of Tirzepatide Following FDA’s Shortage Resolution

Eli Lilly's Legal Intervention:
Eli Lilly is seeking to join a lawsuit filed by the Outsourcing Facilities against the FDA, aiming to reverse the FDA's October 2024 determination that the shortage of its GLP-1 medications, Mounjaro and Zepbound, has ended23.

Background of the Shortage:
Mounjaro and Zepbound, both containing tirzepatide, were temporarily added to the FDA's drug shortage list due to overwhelming demand. During this period, some 503B compounding pharmacies began manufacturing and marketing unapproved versions of the medications2.

Eli Lilly's Investment:
Eli Lilly has invested $23 billion in manufacturing expansion to ensure that drugs remain available in sufficient quantities, negating the justification for compounded alternatives2.

FDA's Stance:
The FDA has repeatedly warned against the use of compounded versions of GLP-1 medications, citing significant safety concerns. As of December 2024, the FDA reaffirmed that the shortage is over, rejecting evidence from compounding pharmacies2.

Legal Objective:
Eli Lilly aims to block the FDA's determination that the shortage has ended, which would allow compounding pharmacies to continue selling unapproved versions of the drugs23.

Sources:

2. https://www.beckershospitalreview.com/pharmacy/eli-lilly-to-join-lawsuit-over-glp-1-shortage-4-things-to-know.html

3. https://www.fiercepharma.com/pharma/lilly-looks-wade-legal-fracas-between-fda-and-compounders-following-end-tirzepatide-shortage