Trintellix
An oral daily medication used to treat major depressive disorder in adults.
Where Vortioxetine is approved
All regulators →Of the three regulators tracked here, the first to approve Vortioxetine was the US, on 30 Sep 2013. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Vortioxetine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Vortioxetine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 21 Sep 2032 (US 9278096, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 30 Dec 2031 (US 8722684, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 23 Feb 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Vortioxetine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Vortioxetine works
All drug targets →- Serotonin 1a (5-HT1a) receptor agonist AgonistTarget: HTR1A 5-hydroxytryptamine receptor 1A✓ In ChEMBL and the Guide to Pharmacology
- Serotonin transporter inhibitor InhibitorTarget: SLC6A4 solute carrier family 6 member 4✓ In ChEMBL and the Guide to Pharmacology
- Serotonin 3a (5-HT3a) receptor antagonist AntagonistTarget: HTR3A 5-hydroxytryptamine receptor 3A✓ In ChEMBL and the Guide to Pharmacology
- Antagonist at HTR7 Primary targetTarget: HTR7 5-hydroxytryptamine receptor 7Guide to Pharmacology only
- Partial agonist at HTR1B Primary targetTarget: HTR1B 5-hydroxytryptamine receptor 1BGuide to Pharmacology only
- PainPhase 3
- Burning mouth syndromePhase 3
- Depressive disorderPhase 3
- Generalized anxiety disorderPhase 3
- Hoarding disorderPhase 3
- Mood disorderPhase 3
- SchizophreniaPhase 2/3
- Anxiety disorderPhase 2
- Attention deficit-hyperactivity disorderPhase 2
- Bipolar disorderPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2104993, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7351, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Vortioxetine
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Vortioxetine. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Vortioxetine for treating major depressive episodes NICE TA367 | Recommended | 25 Nov 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Vortioxetine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 12 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: BrintellixEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Vortioxetine
- ATC code
- N06AX26
- ChEMBL
- CHEMBL2104993
- DrugBank
- DB09068
- PubChem CID
- 9966051
- CAS number
- 508233-74-7
- FDA UNII
- 3O2K1S3WQV
- Wikidata
- Q3563148
- Wikipedia
- Vortioxetine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Trintellix is used for
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).
How it works
12.1 Mechanism of Action The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.