Guaifenesin
As of the edition of 20 October 2026, Guaifenesin is a small molecule: marketed, first approved in 1946 (CH); 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 2005
- Kind
- Small molecule
- Brand name
- Mucinex
- First approved
- 22 February 1946 (CH)
- Approvals on record
- 30 in 6 regions
- Holder of the most recent approval
- Reckitt Benckiser; 12 holders in all
- Registered trials
- 22, 1 stopped early
- Disease areas
- Lungs and airways; Infections; Ear, nose and throat; Immune system; Urinary and reproductive; 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.
SOVEREIGN PHARMACEUTICALS LLC holds a later exclusivity on its own new formulation or combination product, ending 2035; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 6 | 0 | 0 |
| Phase 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| Phase 3 | 2 | 1 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Aché Laboratórios Farmacêuticos | Applicant | 2005 to now |
| GSK | Applicant and Lead sponsor of trials | 2005 to now |
| Reckitt Benckiser | Acquired holder and Lead sponsor of trials | 2007 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 2011 to now |
| Bayer | Later holder | 2021 to now |