Magnesium sulfate anhydrous
As of the edition of 20 October 2026, Magnesium sulfate 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 2021
- Kind
- Small molecule
- Brand name
- Tis-U-Sol In Plastic Container
- First approved
- 1 January 1982 (US)
- Approvals on record
- 31 in 3 regions
- Holder of the most recent approval
- Baxter Healthcare; 9 holders in all
- Registered trials
- 236, 16 stopped early
- Disease areas
- Nervous system; Urinary and reproductive; Pregnancy and women's health; Heart and blood vessels; Lungs and airways; Cancer
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.
Azurity Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 89 | 47 | 15 | 2 |
| Phase 1 | 13 | 7 | 4 | 0 |
| Phase 2 | 21 | 12 | 5 | 2 |
| Phase 3 | 44 | 24 | 8 | 6 |
| Phase 4 | 69 | 31 | 19 | 6 |
| All trials | 236 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Astellas | Applicant | 1986 to now |
| Baxter Healthcare | Applicant | 1990 to now |
| Abbott | Later holder | 1994 to now |
| Pfizer | Acquired holder | 2005 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Nihon Pharmaceutical | Applicant | 2021 to now |