Potassium citrate anhydrous
As of the edition of 20 October 2026, Potassium citrate anhydrous is a small molecule: marketed, first approved in 1985 (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 2025
- Kind
- Small molecule
- Brand name
- Urocit-K
- First approved
- 30 August 1985 (US)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Clinigen; 5 holders in all
- Registered trials
- 18, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Nutrition and metabolism; Bones, joints and muscles; Heart and blood vessels; Inherited and neonatal
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 | 4 | 0 | 0 | 1 |
| Phase 1 | 2 | 0 | 2 | 0 |
| Phase 2 | 3 | 2 | 1 | 0 |
| Phase 3 | 4 | 1 | 0 | 1 |
| Phase 4 | 5 | 3 | 1 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mission Pharmacal | Acquired holder | 2003 to now |
| Recordati | Applicant | 2012 to now |
| Ut Southwestern Medctr | Acquired holder | 2014 to now |
| Advicenne | Applicant | 2021 to now |
| Clinigen | Applicant | 2025 to now |