Sitagliptin
As of the edition of 20 October 2026, Sitagliptin is a small molecule: marketed, first approved in 2006 (US); acts on DPP4; US protection ends in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Januvia
- First approved
- 16 October 2006 (US)
- Approvals on record
- 56 in 6 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 7 holders in all
- Withdrawn from market
- 22 July 2025 (in some regions)
- Registered trials
- 312, 24 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Immune system; Cancer; Digestive system; Heart and blood vessels
US protection
US protection ends in 2026.
The last listed US drug-substance patent ends in 2026. The application that gives this date is held by Merck & Co..
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 product3 listings count towards this date. The exact date and each listing are in the product.
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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 Sitagliptin.
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 |
|---|---|---|
| DPP4 | Dipeptidyl peptidase 4 | P27487 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 54 | 38 | 2 | 4 |
| Phase 1 | 53 | 47 | 2 | 2 |
| Phase 2 | 38 | 27 | 4 | 3 |
| Phase 3 | 87 | 80 | 0 | 4 |
| Phase 4 | 80 | 57 | 2 | 11 |
| All trials | 312 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2003 to now |
| Ono Pharmaceutical | Applicant and Lead sponsor of trials | 2009 to now |
| Zydus Worldwide DMCC | Later holder | 2023 to now |
| Zydus Lifesciences Global Fze | Acquired holder | 2024 to now |
| Azurity Pharmaceuticals | Later holder | 2025 to now |