Pseudoephedrine
As of the edition of 20 October 2026, Pseudoephedrine is a small molecule: marketed, first approved in 1982 (US); acts on SLC6A2; no US protection 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
- Disophrol
- First approved
- 1 January 1982 (US)
- Approvals on record
- 55 in 6 regions
- Holder of the most recent approval
- Chartwell Rx Sciences; 27 holders in all
- Registered trials
- 54, 4 stopped early
- Disease areas
- Lungs and airways; Ear, nose and throat; Immune system; Infections; Nervous system; Heart and blood vessels
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Pseudoephedrine.
See the 4 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A2 | Sodium-dependent noradrenaline transporter | P23975 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 9 | 1 | 0 |
| Phase 1 | 21 | 20 | 0 | 1 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 11 | 8 | 0 | 2 |
| Phase 4 | 8 | 8 | 0 | 0 |
| All trials | 54 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fisons | Later holder | 1987 to now |
| Bayer | Applicant and Lead sponsor of trials | 1991 to now |
| Johnson & Johnson | Later holder and Lead sponsor of trials | 1992 to now |
| Schering Plough Healthcare | Acquired holder | 2003 to now |
| Organon | Applicant and Lead sponsor of trials | 2006 to now |
| UCB | Acquired holder | 2006 to now |
| GSK | Later holder and Lead sponsor of trials | 2007 to now |
| Sanofi | Applicant and Lead sponsor of trials | 2011 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Merck & Co. | Later holder |