Venlafaxine
As of the edition of 20 October 2026, Venlafaxine is a small molecule: marketed, first approved in 1993 (US); acts on SLC6A4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Effexor
- First approved
- 28 December 1993 (US)
- Approvals on record
- 18 in 4 regions
- Holder of the most recent approval
- Almatica Pharma; 7 holders in all
- Registered trials
- 137, 11 stopped early
- Disease areas
- Mental health; Nervous system; Cancer; Injuries; Skin and connective tissue; Urinary and reproductive
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
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 Venlafaxine.
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 | 29 | 19 | 5 | 1 |
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 14 | 9 | 2 | 3 |
| Phase 3 | 39 | 32 | 3 | 2 |
| Phase 4 | 44 | 32 | 1 | 5 |
| All trials | 137 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1993 to now |
| Osmotica Pharmaceutical | Later holder | 2008 to now |
| Viatris | Acquired holder | 2020 to now |
| Almatica Pharma | Later holder | 2022 to now |