Ceftolozane
As of the edition of 20 October 2026, Ceftolozane is a small molecule: marketed, first approved in 2014 (US); US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Zerbaxa
- First approved
- 19 December 2014 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 29, 5 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Cancer; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. 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 product11 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 11 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 1 | 0 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 6 | 6 | 0 | 0 |
| Phase 3 | 7 | 4 | 1 | 2 |
| Phase 4 | 6 | 1 | 1 | 3 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2009 to now |