NDAORALTABLET2 Generics Approved
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
21
Data completeness
4/8 — Partial
TOPAMAX (topiramate) by Johnson & Johnson is cytochrome p450 3a4 inducers [moa]. First approved in 1996.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOPAMAX (topiramate) is an oral small-molecule anticonvulsant approved in 1996 that works as a cytochrome P450 3A4 inducer. While originally indicated for seizure disorders, it has been widely used off-label for migraine prophylaxis and weight management. The drug's mechanism involves modulation of sodium channels and carbonic anhydrase inhibition, making it relevant across multiple therapeutic areas.
$48MPart D
LOE ApproachingAs LOE approaches, brand team focus shifts from growth initiatives to lifecycle extension and managed decline strategies, with likely reduced headcount and consolidation of commercial efforts.
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.