BUSPAR
LOE ApproachingNDAORALTABLETPriority Review
Approved
Sep 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
BUSPAR by Bristol Myers Squibb is the mechanism of action of buspirone is unknown. Approved for anxiety disorders, the short-term relief of the symptoms of anxiety. First approved in 1986.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Buspar (buspirone) is an oral small-molecule anxiolytic approved in 1986 for short-term relief of anxiety disorder symptoms. Its exact mechanism remains unknown, though it exhibits high affinity for serotonin 5-HT1A receptors and moderate affinity for dopamine D2 receptors, distinguishing it from benzodiazepines by lacking sedative, anticonvulsant, and muscle relaxant effects. It is rapidly absorbed and extensively metabolized, with peak plasma levels occurring 40-90 minutes after oral dosing.
LOE Approaching
As loss of exclusivity approaches, the brand team will shift focus to generic transition management and potentially explore lifecycle extension opportunities; team size may consolidate.
Mechanism of Action
The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. In vitro preclinical studies…
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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.