Avibactam
As of the edition of 20 October 2026, Avibactam is a small molecule: marketed, first approved in 2015 (US); US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Avycaz
- First approved
- 25 February 2015 (US)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- AbbVie; 4 holders in all
- Registered trials
- 36, 3 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Blood and lymph; Digestive system
US protection
US protection ends in 2033.
The last listed US exclusivity ends in 2033. The application that gives this date is held by AbbVie.
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 product16 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 16 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 5 | 7 | 1 |
| Phase 1 | 9 | 8 | 0 | 1 |
| Phase 2 | 7 | 6 | 1 | 0 |
| Phase 3 | 3 | 1 | 1 | 1 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2008 to now |