NDAORALCONCENTRATE2 Generics Approved
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
13
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLOFT (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) approved for oral use as a concentrate formulation. It is indicated for depression, anxiety disorders, OCD, PTSD, and panic disorder by increasing serotonin availability in the central nervous system. This foundational psychiatric agent has been a standard-of-care treatment for over two decades.
$14MPart D
LOE ApproachingLoss of exclusivity is imminent, signaling a transition from brand defense to generic containment and potential team consolidation or redeployment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets
Started Nov 2018
36 enrolled
Healthy
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
Started Sep 2012
30 enrolled
Healthy
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Started Nov 2010
30 enrolled
Healthy
Drug Use Investigation of Jzoloft.
Started Apr 2007
2,272 enrolled
Panic DisorderDepression
Special Investigation Of J Zoloft For Panic Disorder Patients
Started Apr 2007
997 enrolled
Panic Disorder
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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.