NDAORALTABLET
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
3/8 — Basic
ZOLOFT (sertraline hydrochloride) by Viatris (2) is 12. First approved in 1991.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Zoloft (sertraline hydrochloride) is an oral small-molecule SSRI approved in 1991 for depression and anxiety disorders. It works by selectively inhibiting neuronal reuptake of serotonin (5-HT) in the central nervous system, increasing serotonergic activity. The drug demonstrates high selectivity for serotonin reuptake with minimal effects on norepinephrine and dopamine systems.
LOE Approaching
As a mature product approaching loss of exclusivity with low competitive pressure (30/100), the brand team is likely focused on defending market share through cost management and lifecycle optimization rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT). 12.2 Pharmacodynamics Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human…
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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.