PROZAC
LOE ApproachingNDAORALSOLUTIONPriority Review
Approved
Apr 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
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 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROZAC (fluoxetine) is an oral solution small-molecule SSRI approved in 1991 for depressive episodes in Bipolar I Disorder and treatment-resistant depression. It works by inhibiting CNS neuronal uptake of serotonin, modulating mood and emotional regulation. The drug remains a foundational antidepressant despite its approaching loss of exclusivity.
LOE Approaching
With LOE approaching and competitive pressure at 30%, the PROZAC brand team is likely focused on lifecycle extension and generic transition planning rather than growth initiatives.
Mechanism of Action
unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Clinical Trials (3)
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
Started Feb 2006
32 enrolled
Healthy
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.