TOPAMAX
LOE ApproachingNDAORALTABLET
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 17h ago · AI intelligence enriched 1mo 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
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Started Nov 2005
35 enrolled
Healthy
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Started Nov 2005
36 enrolled
Healthy
Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Started Nov 2005
36 enrolled
Healthy
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
Started Jun 2005
406 enrolled
MigraineClassic MigraineCommon Migraine
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Started Dec 2002
114 enrolled
Epilepsy, Rolandic
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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.