Ampicillin
As of the edition of 20 October 2026, Ampicillin is a small molecule: marketed, first approved in 1965 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Penbritin-S
- First approved
- 1 July 1965 (ES)
- Approvals on record
- 23 in 5 regions
- Holder of the most recent approval
- FRESENIUS KABI CANADA LTD; 6 holders in all
- Registered trials
- 31, 6 stopped early
- Disease areas
- Infections; Urinary and reproductive; Pregnancy and women's health; Digestive system; Inherited and neonatal; Lungs and airways
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 8 | 1 | 1 |
| Phase 2 | 1 | 0 | 0 | 1 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 15 | 6 | 5 | 3 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Acquired holder | 2003 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2003 to now |
| Meiji Seika Pharma | Applicant |