How many Mounjaro biosimilars are approved?

Drug Landscape tracks 0 approved Mounjaro biosimilars across global regulators. 0 additional applications are filed and 0 are in Phase 3.

Is Mounjaro still patent-protected?

All tracked patents on Mounjaro have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-05-16 · How we verify

Mounjaro biosimilars

Complete Mounjaro (TIRZEPATIDE) biosimilar landscape: 0 approved biosimilars, 0 filed, 0 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

0 approved 0 filed 0 Phase 3 All key patents expired

About Mounjaro

Mounjaro (TIRZEPATIDE) — originally marketed by Eli Lilly. Class: Dual GIP/GLP-1 receptor agonist. Target: GIP receptor and GLP-1 receptor. Area: Metabolic. First approved 2022-01-01.

Approved biosimilars (0)

No approved biosimilars tracked for this originator.

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (0)

No biosimilars in Phase 3 clinical trials.

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

Subscribe to biosimilar updates

Every regulatory action on Mounjaro or any of its biosimilars:

Mounjaro updates RSS
All TIRZEPATIDE (originator + biosimilars) RSS

Mounjaro full drug profile
Mounjaro CI brief
All biosimilar landings