NDAORALCAPSULE
Approved
Oct 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
4/8 — Partial
PAXIL (paroxetine hydrochloride) by Aurobindo Pharma is 12. First approved in 1998.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PAXIL (paroxetine hydrochloride) is an oral selective serotonin reuptake inhibitor (SSRI) approved for treatment of major depressive disorder, social anxiety disorder, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, and post-traumatic stress disorder. It works by inhibiting neuronal reuptake of serotonin in the central nervous system, potentiating serotonergic activity.
$0.002BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Medicare spending; commercial teams face significant generic pressure and declining volume opportunities.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of PAXIL in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin…
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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.