NDAORALCAPSULE2 Generics Approved
Approved
Oct 1998
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
21
Data completeness
3/8 — Basic
TOPAMAX (topiramate) by Johnson & Johnson is cytochrome p450 3a4 inducers [moa]. First approved in 1998.
Drug data last refreshed 44m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOPAMAX (topiramate) is an oral small-molecule anticonvulsant approved in 1998 that works as a cytochrome P450 3A4 inducer. While originally developed for seizure disorders, it has been widely used off-label for migraine prophylaxis, weight management, and psychiatric conditions. The drug's multiple mechanisms of action and broad off-label adoption have made it a cornerstone therapy across multiple therapeutic areas.
LOE Approaching
As LOE approaches, the brand team is likely contracting; careers here focus on maximizing remaining exclusivity and preparing for generic competition rather than growth initiatives.
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 (21)
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.