NDAORALTABLET, EXTENDED RELEASE
Approved
May 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
VENLAFAXINE HYDROCHLORIDE (venlafaxine hydrochloride) by Aurobindo Pharma is cns. First approved in 2008.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Venlafaxine hydrochloride is an oral extended-release SNRI (serotonin-norepinephrine reuptake inhibitor) that works by inhibiting neuronal reuptake of serotonin and norepinephrine, with weak dopamine reuptake inhibition. It is a mature generic antidepressant indicated for depression and anxiety disorders. The drug has been approved since 2008 and is now approaching loss of exclusivity.
LOE Approaching
As a mature extended-release formulation approaching LOE, commercial teams are likely consolidating with focus on operational efficiency and managed care positioning rather than growth-stage expansion.
Mechanism of Action
CNS. Preclinical studies have shown that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets
Started May 2024
736 enrolled
Major Depressive Disorder
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
Started Jul 2023
555 enrolled
Generalized Anxiety Disorder
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
Started Feb 2003
24 enrolled
Healthy
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions
Started Sep 2002
18 enrolled
Healthy
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions
Started Sep 2002
24 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.