Potassium sulfate
As of the edition of 20 October 2026, Potassium sulfate is a small molecule: marketed, first approved in 2010 (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 2021
- Kind
- Small molecule
- Brand name
- Suprep Bowel Prep Kit
- First approved
- 5 August 2010 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Nihon Pharmaceutical; 4 holders in all
- Registered trials
- 4, 0 stopped early
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 | 0 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Nihon Pharmaceutical | Originator | 2021 to now |