FDA Ends Shortage of Eli Lilly’s Weight-Loss Drug, Restricts Copycat Versions

The FDA has ruled that Eli Lilly's tirzepatide supply meets demand, requiring compounding pharmacies to phase out unbranded alternatives within 60 to 90 days.

The FDA reaffirmed that the shortage of tirzepatide, the active ingredient in Eli Lilly's Mounjaro and Zepbound, is resolved after a reevaluation prompted by legal challenges.
Compounding pharmacies, which had been producing cheaper, unbranded versions of the drug, must cease production within 60 to 90 days depending on their facility type.
The FDA's decision follows two years of shortages and significant demand for GLP-1 class medications, which are used for diabetes and weight loss.
Eli Lilly has expanded manufacturing capacity to meet demand, while the FDA emphasized that compounded versions could pose safety risks due to unregulated quality standards.
Other GLP-1 drugs, including Novo Nordisk’s Ozempic and Wegovy, remain on the FDA’s shortage list, with no immediate changes to their availability.