NDAORALTABLET
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
ZOLOFT (sertraline hydrochloride) by Viatris (2) is 12. Approved for depression, panic disorder. First approved in 1991.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLOFT (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) approved in 1991 for depression and panic disorder. It works by blocking neuronal reuptake of serotonin in the CNS, potentiating serotonergic activity with minimal effects on norepinephrine and dopamine. The drug is available as an oral tablet with linear dose-proportional pharmacokinetics and a 26-hour half-life.
LOE Approaching
Stable
As LOE approaches, ZOLOFT teams are transitioning toward managed decline and generic transition support, with reduced marketing spend and smaller field populations.
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.