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Effexor XR

Venlafaxine

An oral daily antidepressant used to treat major depressive disorder and anxiety disorders.

Generic name
Venlafaxine
Brand name
Effexor XR
Route
Oral
Marketed by
Viatris
First FDA approval
20 Oct 1997

Where Venlafaxine is approved

All regulators →

Of the three regulators tracked here, the first to approve Venlafaxine was the US, on 28 Dec 1993. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
28 Dec 1993
Effexor
NDA020151 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
18 Jul 1994
Effexor
Notice of Compliance 5631
First new-drug NOC

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.

Venlafaxine patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Venlafaxine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Effexor Xr, Venlafaxine Besylate, Venlafaxine Hydrochloride
  • 1 listed patent; the last listed expires 16 May 2028 (US 7776358).
See the Orange Book listing for NDA 020699
Patents and exclusivities above are pooled across 3 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 12 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 Venlafaxine

All medicines →
ENNHS England
£59.5m
6,528,730 items dispensed, Aug 2025 to Jul 2026
+26% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$43.4m
2,914,749 prescriptions in 2025 · Venlafaxine Hydrochloride, Venlafaxine, Effexor
-3% on 2024
Amount Medicaid reimbursed, before rebates

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 Venlafaxine works

All drug targets →
  • Serotonin transporter inhibitor Inhibitor
    Target: SLC6A4 solute carrier family 6 member 4
    ✓ In ChEMBL and the Guide to Pharmacology
  • Norepinephrine transporter inhibitor Inhibitor
    Target: SLC6A2 solute carrier family 6 member 2
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Breast cancerPhase 3
  • Generalized anxiety disorderPhase 3
  • Panic disorderPhase 3
  • Social phobiaPhase 3
  • Bipolar disorderPhase 2
  • Neuropathic painPhase 2
  • Rheumatoid arthritisPhase 2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL637, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7321, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Venlafaxine

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

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 Venlafaxine

ATC code
N06AX16
ChEMBL
CHEMBL637
DrugBank
DB00285
PubChem CID
5656
CAS number
93413-69-5
FDA UNII
GRZ5RCB1QG
Wikidata
Q898407
Wikipedia
Venlafaxine

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 Effexor XR is used for

Effexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] • Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Social Anxiety Disorder (SAD) ( 1 ) • Panic Disorder (PD) ( 1 )

How it works

12.1 Mechanism of Action The mechanism of action of venlafaxine in the treatment of MDD, GAD, SAD, and PD is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake.

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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.

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 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.