Escitalopram
As of the edition of 20 October 2026, Escitalopram is a small molecule: marketed, first approved in 2001 (CH); acts on SLC6A4; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2004
- Kind
- Small molecule
- Brand name
- Lexapro
- First approved
- 21 December 2001 (CH)
- Approvals on record
- 14 in 6 regions
- Holder of the most recent approval
- Almatica Pharma; 8 holders in all
- Registered trials
- 285, 30 stopped early
- Disease areas
- Mental health; Nervous system; Urinary and reproductive; Heart and blood vessels; Digestive system; Infections
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by AbbVie.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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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 Escitalopram.
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 |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 74 | 48 | 10 | 2 |
| Phase 1 | 28 | 22 | 1 | 0 |
| Phase 2 | 21 | 9 | 4 | 5 |
| Phase 3 | 58 | 39 | 4 | 12 |
| Phase 4 | 104 | 73 | 3 | 11 |
| All trials | 285 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Actavis | Applicant and Lead sponsor of trials | 2002 to now |
| Lundbeck | Applicant and Lead sponsor of trials | 2004 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2019 to now |
| Almatica Pharma | Later holder | 2025 to now |
| Mochida Pharmaceutical | Applicant |