NDAORALCONCENTRATE
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
ZOLOFT (sertraline hydrochloride) by Viatris (2) is 12. First approved in 1999.
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 selective serotonin reuptake inhibitor (SSRI) approved for depression, anxiety disorders, OCD, PTSD, panic disorder, and premenstrual dysphoric disorder. It works by inhibiting neuronal reuptake of serotonin (5-HT) in the central nervous system, potentiating serotonergic activity. The drug has a well-established safety profile with minimal off-target receptor binding and no monoamine oxidase inhibition.
$14MPart D
LOE ApproachingDeclining
As a mature, LOE-approaching product with modest Part D spending, the brand team is likely focused on defensive strategies and cost 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.