Amdinocillin pivoxil
As of the edition of 20 October 2026, Amdinocillin pivoxil is a small molecule: marketed, first approved in 1981 (FR).
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
- Pivya
- First approved
- 10 April 1981 (FR)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Alembic Pharmaceuticals; 3 holders in all
- Registered trials
- 6, 1 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Infections
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 2 | 1 | 0 | 0 | 1 |
| Phase 3 | 2 | 1 | 1 | 0 |
| Phase 4 | 3 | 1 | 2 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Karo Healthcare | Applicant | 2016 to now |
| Alembic Pharmaceuticals | Acquired holder | 2025 to now |