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 7h ago · AI intelligence enriched 10h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXTELLAR XR is an extended-release formulation of oxcarbazepine, an anti-epileptic agent approved in 2012 for seizure management. It works by blocking voltage-sensitive sodium channels and stabilizing hyperexcited neural membranes, reducing seizure propagation in the brain. The drug also modulates potassium conductance and high-voltage activated calcium channels to prevent seizure spread.
$0.031BPart D
LOE Approaching7mo to LOEProduct is approaching loss of exclusivity in April 2027, signaling contraction of brand team investment and a shift toward generic transition planning.
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
Worked on OXTELLAR XR at Supernus Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.