Sodium bicarbonate
As of the edition of 20 October 2026, Sodium bicarbonate is a small molecule: marketed, first approved in 1955 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Bss Plus
- First approved
- 21 January 1955 (CH)
- Approvals on record
- 71 in 5 regions
- Holder of the most recent approval
- Baxter Healthcare; 22 holders in all
- Registered trials
- 112, 13 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Nutrition and metabolism; Heart and blood vessels; Inherited and neonatal; 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 | 26 | 14 | 2 | 2 |
| Phase 1 | 19 | 13 | 1 | 3 |
| Phase 2 | 11 | 5 | 3 | 2 |
| Phase 3 | 27 | 15 | 4 | 3 |
| Phase 4 | 29 | 16 | 4 | 3 |
| All trials | 112 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant | 1963 to now |
| Pfizer | Applicant | 1974 to now |
| Alcon | Later holder | 1982 to now |
| Abbott | Applicant and Acquired holder | 1986 to now |
| Reckitt Benckiser | Later holder | 2013 to now |
| EA Pharma | Applicant | 2018 to now |
| Amneal Pharmaceuticals | Later holder | 2026 to now |
| Baxter Healthcare | Later holder | 2026 to now |