NDAORALSUSPENSION
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
6/8 — Strong
DILANTIN-125 (phenytoin) by Viatris (2) is cytochrome p450 1a2 inducers [moa]. Approved for epilepsy, seizures. First approved in 1953.
Drug data last refreshed Yesterday · AI intelligence enriched 2w 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 prevent seizures. It treats epilepsy, traumatic brain injury, subarachnoid hemorrhage, and several other neurological and hematologic conditions. The drug is a foundational anticonvulsant with decades of clinical use and extensive drug-drug interaction data.
$0.186MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Part D spending ($186K, 535 claims in 2023), indicating a small and shrinking commercial footprint with limited team expansion opportunities.
Mechanism of Action
Cytochrome P450 1A2 Inducers
Pharmacologic Class:
Anti-epileptic Agent
Indications (2)
Clinical Trials (17)
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
A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)
Started May 2024
28 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.