NDAORALSOLUTION
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
EPRONTIA (topiramate) by R-Pharm US is cytochrome p450 3a4 inducers [moa]. First approved in 2021.
Drug data last refreshed 15h ago · AI intelligence enriched 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPRONTIA is an oral solution formulation of topiramate, a cytochrome P450 3A4 inducer approved in November 2021. The generic active ingredient has multiple established indications, though the specific labeled uses for this branded formulation are not detailed in available data. This product represents a reformulated delivery of a well-known anticonvulsant with broader neurological applications.
$0.522MPart D
Peak13.9 years to LOEProduct is in peak commercial phase with modest Medicare Part D penetration (~$522K), suggesting a niche or specialized market positioning with potential for stable, focused team structure.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.