Cilastatin
As of the edition of 20 October 2026, Cilastatin is a small molecule: marketed, first approved in 1985 (US); acts on DPEP1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Primaxin
- First approved
- 26 November 1985 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Registered trials
- 22, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Blood and lymph; Cancer
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. 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 product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 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 Cilastatin.
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 |
|---|---|---|
| DPEP1 | Dipeptidase 1 | P16444 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 8 | 4 | 4 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| Phase 4 | 2 | 0 | 0 | 2 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 2009 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2011 to now |