Paroxetine
As of the edition of 20 October 2026, Paroxetine is a small molecule: marketed, first approved in 1992 (FR); acts on SLC6A4; 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 1993
- Kind
- Small molecule
- Brand name
- Paxil
- First approved
- 24 June 1992 (FR)
- Approvals on record
- 26 in 6 regions
- Holder of the most recent approval
- Legacy Pharma Inc Sezc; 4 holders in all
- Registered trials
- 155, 12 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Urinary and reproductive; Digestive system; Infections
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.
Legacy Pharma Inc Sezc holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Paroxetine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 37 | 26 | 1 | 3 |
| Phase 1 | 31 | 29 | 2 | 0 |
| Phase 2 | 22 | 17 | 1 | 4 |
| Phase 3 | 28 | 27 | 0 | 1 |
| Phase 4 | 37 | 28 | 0 | 4 |
| All trials | 155 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator, Applicant and Lead sponsor of trials | 1992 to now |
| Synthon Pharmaceuticals | Later holder | 2003 to now |
| Noven Therapeutics | Later holder and Lead sponsor of trials | 2008 to now |
| Sebela | Acquired holder | 2016 to now |
| Apotex | Acquired holder | 2022 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |