PROZAC
LOE ApproachingNDAORALSOLUTIONPriority Review
Approved
Apr 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
PROZAC by Eli Lilly and Company is unknown, it is presumed to be linked to its inhibition of cns neuronal uptake of serotonin. Approved for depressive episodes associated with bipolar i disorder, the treatment of treatment resistant depression. First approved in 1991.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROZAC is an oral solution antidepressant approved in 1991 by Eli Lilly for treatment of depression. It works through inhibition of CNS neuronal reuptake of serotonin (5-HT), though the exact mechanism remains presumed rather than fully characterized. This small molecule SSRI represents a foundational class in psychiatric pharmacotherapy.
LOE Approaching
With LOE approaching and moderate competitive pressure (30%), the PROZAC brand team faces portfolio contraction; career stability depends on generic transition strategy and lifecycle extension initiatives.
Mechanism of Action
unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Clinical Trials (2)
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Started Jun 1996
46 enrolled
Depression
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions
Started May 1996
24 enrolled
Depression
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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.