NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
18
Data completeness
6/8 — Strong
OXTELLAR XR (oxcarbazepine) by Supernus Pharmaceuticals is 10-monohydroxy metabolite (mhd) of oxcarbazepine [see ]. Approved for epilepsy. First approved in 2012.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXTELLAR XR is an extended-release oral formulation of oxcarbazepine, an anti-epileptic agent approved by the FDA in October 2012. It is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. The drug works by blocking voltage-sensitive sodium channels, stabilizing hyperexcited neural membranes, and inhibiting repetitive neuronal firing through its active metabolite MHD, with additional contributions from increased potassium conductance and modulation of high-voltage activated calcium channels. OXTELLAR XR represents a convenient once-daily dosing alternative to immediate-release oxcarbazepine formulations in the competitive antiepileptic drug landscape.
$0.0BPart D
11mo to LOEMechanism 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 (1)
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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.