NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
TROKENDI XR (topiramate) by Supernus Pharmaceuticals is cytochrome p450 3a4 inducers [moa]. First approved in 2013.
Drug data last refreshed 18h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TROKENDI XR is an extended-release oral capsule formulation of topiramate, a cytochrome P450 3A4 inducer approved in 2013. The drug is indicated for seizure management and migraine prophylaxis, working through multiple mechanisms including sodium channel blockade and carbonic anhydrase inhibition. It serves patients requiring once-daily dosing convenience for chronic neurological conditions.
$0.033BPart D
LOE Approaching1.5 years to LOEProduct approaching loss of exclusivity with modest Medicare utilization suggests a contracting brand team focused on generic transition planning and market defense.
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.