NDAINJECTIONINJECTABLE
Approved
Mar 1956
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
DILANTIN (phenytoin sodium) by Pfizer is voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges. Approved for generalized tonic-clonic (grand mal), complex partial (psychomotor, temporal lobe) seizures and 3 more indications. First approved in 1956.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DILANTIN (phenytoin sodium) is a classic anticonvulsant administered by injection that works by blocking voltage-dependent sodium channels to reduce high-frequency neuronal discharges. It is indicated for generalized tonic-clonic seizures, complex partial seizures, and prevention of seizures during or after neurosurgery. The drug represents a foundational therapy in epilepsy management with over 65 years of clinical use.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling likely contraction in brand team size and transition toward generic defense or market exit strategies.
Mechanism of Action
voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.
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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.