Azithromycin
As of the edition of 20 October 2026, Azithromycin is a small molecule: marketed, first approved in 1991 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2000
- Kind
- Small molecule
- Brand name
- Zithromax
- First approved
- 1 November 1991 (US)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- Thea Pharma; 5 holders in all
- Registered trials
- 398, 74 stopped early
- Disease areas
- Infections; Lungs and airways; Urinary and reproductive; Immune system; Eye; Pregnancy and women's health
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 88 | 60 | 9 | 7 |
| Phase 1 | 40 | 32 | 1 | 2 |
| Phase 2 | 74 | 30 | 5 | 26 |
| Phase 3 | 114 | 67 | 9 | 27 |
| Phase 4 | 82 | 44 | 12 | 12 |
| All trials | 398 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Later holder and Lead sponsor of trials | 1991 to now |
| Teva | Later holder and Lead sponsor of trials | 2002 to now |
| Senju Pharmaceutical | Applicant | 2019 to now |
| Thea Pharma | Acquired holder | 2022 to now |