Tirzepatide
As of the edition of 20 October 2026, Tirzepatide is a protein: marketed, first approved in 2022 (US); acts on GIPR; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Protein
- Brand name
- Mounjaro (autoinjector)
- First approved
- 13 May 2022 (US)
- Approvals on record
- 78 in 5 regions
- Holder of the most recent approval
- ELI LILLY DO BRASIL LTDA; 3 holders in all
- Registered trials
- 195, 4 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Urinary and reproductive; Cancer; Heart and blood vessels; Pregnancy and women's health
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Eli Lilly.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product174 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 174 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Tirzepatide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GIPR | Gastric inhibitory polypeptide receptor | P48546 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 30 | 10 | 18 | 1 |
| Phase 1 | 36 | 24 | 12 | 0 |
| Phase 2 | 52 | 8 | 41 | 2 |
| Phase 3 | 46 | 26 | 20 | 0 |
| Phase 4 | 31 | 3 | 27 | 1 |
| All trials | 195 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Originator, Applicant and Lead sponsor of trials | 2016 to now |