NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
18
Data completeness
5/8 — Partial
OXTELLAR XR (oxcarbazepine) by Supernus Pharmaceuticals is 10-monohydroxy metabolite (mhd) of oxcarbazepine [see ]. First approved in 2012.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXTELLAR XR is an extended-release formulation of oxcarbazepine, a small-molecule antiseizure agent approved in 2012. It works by blocking voltage-sensitive sodium channels and modulating calcium channels to stabilize neuronal membranes and prevent seizure propagation. The drug is indicated for epilepsy management in patients requiring oral antiseizure therapy.
$31MPart D
LOE Approaching10mo to LOEProduct is in advanced lifecycle stage approaching loss of exclusivity (2027), signaling smaller and more defensive commercial team focus.
Mechanism of Action
10-monohydroxy metabolite (MHD) of oxcarbazepine [see ]. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in…
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.