NDAORALTABLET
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PAXIL (paroxetine hydrochloride) by Aurobindo Pharma is 12. First approved in 1992.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PAXIL (paroxetine hydrochloride) is an oral SSRI approved in 1992 for major depressive disorder, social anxiety disorder, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, and PTSD. It works by inhibiting neuronal reuptake of serotonin in the central nervous system, thereby potentiating serotonergic activity. The drug is completely absorbed orally and reaches steady state in approximately 10 days.
LOE Approaching
Product is in late-lifecycle stage with approaching loss of exclusivity; brand teams should anticipate transition to generic defense and market consolidation strategies.
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.