Cefdinir
As of the edition of 20 October 2026, Cefdinir is a small molecule: marketed, first approved in 1997 (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 2024
- Kind
- Small molecule
- Brand name
- Omnicef
- First approved
- 4 December 1997 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Eurofarma Laboratorios; 2 holders in all
- Registered trials
- 12, 0 stopped early
- Disease areas
- Ear, nose and throat; Infections; Nutrition and metabolism; Skin and connective tissue
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 | 1 | 1 | 0 | 0 |
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Later holder and Lead sponsor of trials | 2002 to now |
| AbbVie | Acquired holder | 2012 to now |
| Eurofarma Laboratorios | Applicant | 2024 to now |
| Pfizer | Originator | 1997 to 2012 |