Mannitol
As of the edition of 20 October 2026, Mannitol is a small molecule: marketed, first approved in 1963 (CA); 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 2012
- Kind
- Small molecule
- Brand name
- Sorbitol-Mannitol In Plastic Container
- First approved
- 31 December 1963 (CA)
- Approvals on record
- 48 in 5 regions
- Holder of the most recent approval
- Pharmaxis; 11 holders in all
- Registered trials
- 71, 8 stopped early
- Disease areas
- Lungs and airways; Nervous system; Cancer; Digestive system; Immune system; Inherited and neonatal
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.
Pharmaxis 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 | 18 | 10 | 0 | 3 |
| Phase 1 | 12 | 10 | 0 | 2 |
| Phase 2 | 14 | 9 | 1 | 1 |
| Phase 3 | 18 | 12 | 2 | 2 |
| Phase 4 | 9 | 7 | 0 | 0 |
| All trials | 71 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant and Later holder | 1966 to now |
| Pfizer | Applicant, Acquired holder and Lead sponsor of trials | 1970 to now |
| Pharmaxis | Applicant and Acquired holder | 2012 to now |
| Bayer | Later holder and Lead sponsor of trials | 2013 to now |
| Chiesi | Later holder | 2020 to now |
| Otsuka | Acquired holder | 2025 to now |
| Abbott | Later holder | |
| Baxter Healthcare | Later holder | |
| Merck & Co. | Applicant |