NDAORALCAPSULE
Approved
Jun 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
BRISDELLE (paroxetine) by Enterprise Therapeutics is ssri. Approved for major depressive disorder, panic disorder, generalized anxiety disorder. First approved in 2013.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRISDELLE is a paroxetine capsule approved in 2013 for major depressive disorder, panic disorder, and generalized anxiety disorder as an SSRI. The mechanism of action for its vasomotor symptom indication remains unknown, though serotonergic potentiation is presumed for psychiatric indications. It is an oral small-molecule antidepressant competing in a crowded CNS market.
Peak2.9 years to LOE
BRISDELLE is at peak lifecycle with declining patent coverage; commercial teams should prepare for competitive defense and potential market contraction within 2-3 years.
Mechanism of Action
SSRI. Paroxetine capsules are not an estrogen, and its mechanism of action for the treatment of VMS is unknown.
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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.