Amoxicillin
As of the edition of 20 October 2026, Amoxicillin is a small molecule: marketed, first approved in 1972 (ES); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1992
- Kind
- Small molecule
- Brand name
- Amoxil
- First approved
- 1 June 1972 (ES)
- Approvals on record
- 81 in 6 regions
- Holder of the most recent approval
- Phathom Pharmaceuticals; 17 holders in all
- Registered trials
- 394, 30 stopped early
- Disease areas
- Infections; Lungs and airways; Digestive system; Mouth and teeth; Cancer; Immune system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Phathom Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2032; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 104 | 68 | 10 | 4 |
| Phase 1 | 36 | 27 | 4 | 1 |
| Phase 2 | 25 | 15 | 4 | 2 |
| Phase 3 | 76 | 45 | 12 | 7 |
| Phase 4 | 153 | 82 | 18 | 16 |
| All trials | 394 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant, Later holder and Lead sponsor of trials | 1998 to now |
| Takeda | Applicant and Lead sponsor of trials | 2011 to now |
| Pragma Pharmaceuticals | Acquired holder | 2019 to now |
| Us Antibiotics | Acquired holder | 2021 to now |
| Astellas | Later holder | |
| AstraZeneca | Later holder | |
| Eisai | Later holder | |
| Mitsubishi Tanabe Pharma | Later holder | |
| Shionogi | Later holder | |
| Taisho Pharmaceutical | Later holder |