NDAORALTABLETPriority Review
Approved
Jun 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
Priority Review
Drug Shortage Active
KLONOPIN is currently in shortage. Reason: Available. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
KLONOPIN (clonazepam) by Roche is clinical pharmacology pharmacodynamics the precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (gaba), the major inhibitory neurotransmitter in the central nervous system. First approved in 1975.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KLONOPIN (clonazepam) is a benzodiazepine that enhances GABA activity in the central nervous system to suppress neuronal excitability. Approved in 1975, it treats epilepsy and psychiatric conditions including schizophrenia, schizoaffective disorder, and schizophreniform disorder. It is rapidly absorbed orally with 90% bioavailability and a 30-40 hour elimination half-life.
$4MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D spending; career roles likely focused on generic transition and market maintenance rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the…
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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.