Fluoxetine
As of the edition of 20 October 2026, Fluoxetine is a small molecule: marketed, first approved in 1987 (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 2002
- Kind
- Small molecule
- Brand name
- Prozac
- First approved
- 29 December 1987 (US)
- Approvals on record
- 21 in 3 regions
- Holder of the most recent approval
- Twi Pharmaceuticals; 4 holders in all
- Registered trials
- 160, 20 stopped early
- Disease areas
- Mental health; Nervous system; Heart and blood vessels; Lungs and airways; Chemically induced; Infections
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 Fluoxetine.
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 | 44 | 31 | 4 | 5 |
| Phase 1 | 15 | 11 | 2 | 2 |
| Phase 2 | 42 | 28 | 8 | 5 |
| Phase 3 | 27 | 18 | 1 | 5 |
| Phase 4 | 32 | 21 | 4 | 3 |
| All trials | 160 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 1987 to now |
| Warner Chilcott | Later holder | 2006 to now |
| Edgemont Pharmaceuticals | Later holder | 2011 to now |
| AbbVie | Acquired holder | 2016 to now |
| Twi Pharmaceuticals | Acquired holder | 2023 to now |