NDAORALSUSPENSION
Approved
May 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
4/8 — Partial
TRILEPTAL (oxcarbazepine) by Novartis. Approved for anti-epileptic agent [epc]. First approved in 2001.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRILEPTAL (oxcarbazepine) is an oral anti-epileptic agent approved in 2001 for seizure management. It is a small-molecule anticonvulsant available in suspension formulation. The drug is used as monotherapy or adjunctive therapy in patients with partial seizures.
$21MPart D
LOE Approaching2% of anti-epileptic market
With LOE approaching and modest spending of $21M annually, commercial teams should expect modest headcount and focus shifting toward generic transition management and cost containment.
Mechanism of Action
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia
Started Dec 2018
0Trigeminal Neuralgia
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
Started Sep 2018
31 enrolled
Epilepsy
Protective Role of Oxcarbazepine in Multiple Sclerosis
Started Oct 2014
30 enrolled
Multiple Sclerosis
Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
Started Mar 2014
2,500 enrolled
Epilepsy
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Started Jun 2011
353 enrolled
Epilepsy
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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.