NDAORALSOLUTION
Approved
Nov 2002
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
5
Data completeness
4/8 — Partial
LEXAPRO (escitalopram oxalate) by AbbVie is escitalopram, the s-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (cns) resulting from its inhibition of cns neuronal reuptake of serotonin (5-ht). Approved for anxiety. First approved in 2002.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEXAPRO (escitalopram oxalate) is an oral selective serotonin reuptake inhibitor (SSRI) approved in 2002 for the treatment of anxiety disorders. It works by inhibiting the neuronal reuptake of serotonin (5-HT) in the central nervous system, potentiating serotonergic activity. The drug represents the S-enantiomer of racemic citalopram, offering enhanced pharmacological specificity.
LOE Approaching0mo to LOE
Product approaching loss of exclusivity (May 2026) with moderate competitive pressure (35/100), indicating shrinking team investment and transition focus toward generic stewardship or portfolio repositioning.
Mechanism of Action
escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
Indications (1)
Clinical Trials (5)
Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder
Started Feb 2015
534 enrolled
Depressive Disorder, Major
Lexapro®'s Efficacy After Dose Escalation in Remission Study
Started May 2012
60 enrolled
Major Depressive Disorder
Aripiprazole and Lexapro Drug Interaction Study
Started Aug 2006
25 enrolled
Healthy
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Started Feb 2006
372 enrolled
Insomnia
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Started Feb 2006
372 enrolled
Insomnia
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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.