Sodium phosphate, dibasic, anhydrous
As of the edition of 20 October 2026, Sodium phosphate, dibasic, anhydrous is a small molecule: marketed, first approved in 1982 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Bss Plus
- First approved
- 1 January 1982 (US)
- Approvals on record
- 32 in 2 regions
- Holder of the most recent approval
- MACO PHARMA; 15 holders in all
- Registered trials
- 13, 1 stopped early
- Disease areas
- Digestive system; Eye; Heart and blood vessels; Inherited and neonatal; Nutrition and metabolism; Pregnancy and women's health
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Bausch Health holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 0 | 1 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant | 1982 to now |
| Baxter Healthcare | Later holder | 1990 to now |
| B. Braun Medical | Later holder | 1993 to now |
| Bracco Diagnostics | Acquired holder | 2003 to now |
| Bristol Myers Squibb | Earlier holder | |
| Byk-Mallinckrodt CIL | Later holder |