NDAORALSUSPENSION
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
5/8 — Partial
DILANTIN-125 (phenytoin) by Viatris (2) is cytochrome p450 1a2 inducers [moa]. First approved in 1953.
Drug data last refreshed 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DILANTIN-125 (phenytoin) is an oral anti-epileptic suspension approved in 1953 that works as a cytochrome P450 1A2 inducer to stabilize neuronal membranes and reduce seizure activity. It is a foundational first-line agent for generalized tonic-clonic seizures and partial seizures with complex symptomatology. The drug's mechanism involves prolonging the inactivation phase of sodium channels, thereby raising the seizure threshold.
$0.186BPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with high competitive pressure (30% intensity) signals consolidation of brand support and likely transition to lifecycle management or divestment.
Mechanism of Action
Cytochrome P450 1A2 Inducers
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
Started Jun 2026
30 enrolled
Healthy Volunteers
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
Started Apr 2025
37 enrolled
Healthy Volunteers
A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)
Started Mar 2025
14 enrolled
Healthy
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
Started Aug 2024
30 enrolled
Not Determined
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
Started Jul 2024
35 enrolled
Healthy
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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.