NDAORALSOLUTION
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
EPRONTIA (topiramate) by R-Pharm US is cytochrome p450 3a4 inducers [moa]. Approved for migraine, epilepsy. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPRONTIA is an oral solution formulation of topiramate, a cytochrome P450 3A4 inducer approved in 2021. It treats migraine, epilepsy, obesity, type 2 diabetes, bipolar disorder, and multiple other indications through modulation of neuronal excitability. The broad indication portfolio reflects its off-label use prevalence, which accounts for significant adverse event reporting.
$522KPart D
Peak14.3 years to LOEProduct is at peak lifecycle stage with modest Part D utilization; commercial teams should expect stable to declining growth as generic pressure and off-label use complicate attribution.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications (2)
Clinical Trials (20)
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
Started Oct 2023
545 enrolled
Migraine
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Started Jan 2020
13 enrolled
Obesity, MorbidBariatric SurgeryAdolescent+2 more
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Started Feb 2019
777 enrolled
Migraine
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Started Mar 2018
48 enrolled
MigraineMigraine;MenstrualContraception
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
Started Oct 2017
0MigraineHeadache
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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.