Acetylcysteine
As of the edition of 20 October 2026, Acetylcysteine is a small molecule: marketed, first approved in 1965 (BR); 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 2023
- Kind
- Small molecule
- Brand name
- Mucomyst
- First approved
- 26 February 1965 (BR)
- Approvals on record
- 23 in 6 regions
- Holder of the most recent approval
- Galephar Pharmaceutical; 11 holders in all
- Registered trials
- 337, 42 stopped early
- Disease areas
- Mental health; Chemically induced; Pregnancy and women's health; Urinary and reproductive; Nervous system; Lungs and airways
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.
Apotex 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 | 54 | 32 | 6 | 3 |
| Phase 1 | 50 | 29 | 6 | 10 |
| Phase 2 | 114 | 76 | 14 | 13 |
| Phase 3 | 66 | 26 | 16 | 9 |
| Phase 4 | 53 | 21 | 9 | 7 |
| All trials | 337 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| IBSA Institut Biochimique | Applicant | 1986 to now |
| Bristol Myers Squibb | Acquired holder | 2003 to now |
| Cumberland Pharmaceuticals | Later holder and Lead sponsor of trials | 2004 to now |
| Arbor Pharmaceuticals | Later holder | 2016 to now |
| Maruho | Applicant | 2023 to now |
| Galephar Pharmaceutical | Later holder | 2024 to now |
| Apotex | Acquired holder | 2026 to now |