Cephalexin anhydrous
As of the edition of 20 October 2026, Cephalexin anhydrous is a small molecule: marketed, first approved in 1973 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- Keflex
- First approved
- 1 April 1973 (ES)
- Approvals on record
- 17 in 4 regions
- Holder of the most recent approval
- LABORATÓRIOS BAGÓ DO BRASIL S/A; 6 holders in all
- Registered trials
- 46, 6 stopped early
- Disease areas
- Infections; Pregnancy and women's health; Urinary and reproductive; Skin and connective tissue; Lungs and airways; Cancer
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 | 6 | 2 | 0 | 2 |
| Phase 1 | 16 | 14 | 1 | 1 |
| Phase 2 | 4 | 2 | 1 | 0 |
| Phase 3 | 6 | 3 | 1 | 1 |
| Phase 4 | 14 | 7 | 3 | 2 |
| All trials | 46 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Later holder and Lead sponsor of trials | 2014 to now |
| Pragma Pharmaceuticals | Acquired holder | 2016 to now |