Oxcarbazepine

Overview

Oxcarbazepine is an anti-epileptic medication used in the treatment of partial onset seizures that was first approved for use in the United States in 2000. It is a structural derivative of carbamazepine and exerts a majority of its activity via a pharmacologically active metabolite, MHD, which exists as a racemate in the blood - a pro-drug of the more active (S)-enantiomer is also marketed as a separate anti-epileptic under the name eslicarbazepine. Compared to other anti-epileptic drugs, which are generally metabolized via the cytochrome P450 system, oxcarbazepine has a reduced propensity for involvement in drug-drug interactions owing to its primarily reductive metabolism.

Indication

In the United States, oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. In Canada, oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 6 years of age and older.

Associated Conditions

Partial-Onset Seizures

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia	2025/02/27	NCT06849219	Phase 4	Active, not recruiting	Jinnah Postgraduate Medical Centre
The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children	2023/01/26	NCT05697614	Phase 4	Recruiting	Dr Cipto Mangunkusumo General Hospital
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding	2022/07/11	NCT05450978	N/A	Recruiting	University of Pittsburgh
Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial	2021/08/09	NCT04996199	Phase 4	UNKNOWN	Postgraduate Institute of Dental Sciences Rohtak
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil	2018/10/03	NCT03695094	Phase 1	Completed	UCB Biopharma S.P.R.L.
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)	2018/09/28	NCT03689114	Phase 4	Completed	Mario Negri Institute for Pharmacological Research
Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression	2018/06/26	NCT03567681	Phase 4	UNKNOWN	Collaborative Care Initiative, LLC
Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia	2017/12/15	NCT03374709	Phase 4	Withdrawn	University of Colorado, Denver
Population Pharmacokinetics of Antiepileptic in Pediatrics	2017/06/22	NCT03196466	N/A	Recruiting	Assistance Publique - Hôpitaux de Paris
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies	2016/09/08	NCT02893371	N/A	Terminated	University of New Mexico

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Oxcarbazepine	Ranbaxy Pharmaceuticals Inc.	63304-653	ORAL	60 mg in 1 mL	2/17/2015
Oxcarbazepine	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8292	ORAL	300 mg in 1 1	11/11/2022
Oxcarbazepine	REMEDYREPACK INC.	70518-3921	ORAL	300 mg in 1 1	4/3/2024
OXCARBAZEPINE	REMEDYREPACK INC.	70518-2254	ORAL	600 mg in 1 1	2/28/2024
Oxcarbazepine	Aidarex Pharmaceuticals LLC	33261-841	ORAL	300 mg in 1 1	1/21/2014
Oxcarbazepine	American Health Packaging	60687-733	ORAL	600 mg in 1 1	3/10/2023
Oxcarbazepine	Rebel Distributors Corp	21695-863	ORAL	300 mg in 1 1	10/2/2009
Oxcarbazepine	American Health Packaging	60687-722	ORAL	300 mg in 1 1	3/10/2023
Oxcarbazepine	Advagen Pharma Ltd.	72888-462	ORAL	150 mg in 1 1	6/2/2025
OXCARBAZEPINE	Preferred Pharmaceuticals Inc.	68788-7866	ORAL	600 mg in 1 1	8/22/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
TRILEPTAL ORAL SUSP 60MG/ML	N/A	NOVARTIS PHARMACEUTICALS (HK) LIMITED	N/A	N/A	8/23/2002
TRILOJUB TABLETS 300MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/29/2019
TRILOJUB TABLETS 600MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	8/29/2019

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Oxcarbazepine Tablets 150 mg BULK (EU)	152788	Alphapharm Pty Ltd	Medicine	A	6/3/2008
TRILEPTAL oxcarbazepine 600mg tablet film coated blister pack	76202	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/13/2000
TRILEPTAL oxcarbazepine 60mg/mL oral suspension bottle	81195	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	12/17/2001
TRILEPTAL oxcarbazepine 300mg tablet film coated blister pack	76201	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/13/2000
Oxcarbazepine Tablets 600 mg BULK (EU)	152790	Alphapharm Pty Ltd	Medicine	A	6/3/2008
TRILEPTAL oxcarbazepine 150mg tablet film coated blister pack	76200	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	10/9/2000
Oxcarbazepine Tablets 300 mg BULK (EU)	152789	Alphapharm Pty Ltd	Medicine	A	6/3/2008

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRILEPTAL 300 MG	novartis pharmaceuticals canada inc	02242068	Tablet - Oral	300 MG	4/1/2002
NOVO-OXCARBAZEPINE	novopharm limited	02312034	Tablet - Oral	300 MG	N/A
TRILEPTAL 150 MG	novartis pharmaceuticals canada inc	02242067	Tablet - Oral	150 MG	4/1/2002
SANDOZ OXCARBAZEPINE	Sandoz Canada, Inc.	02466309	Tablet - Oral	300 MG	N/A
TRILEPTAL 600 MG	novartis pharmaceuticals canada inc	02242069	Tablet - Oral	600 MG	4/1/2002
OXCARBAZEPINE	JUBILANT GENERICS LIMITED	02439778	Tablet - Oral	600 MG	N/A
OXCARBAZEPINE	JUBILANT GENERICS LIMITED	02439751	Tablet - Oral	300 MG	N/A
APO-OXCARBAZEPINE	Apotex Inc	02284316	Tablet - Oral	600 MG	8/1/2006
OXCARBAZEPINE	JUBILANT GENERICS LIMITED	02439743	Tablet - Oral	150 MG	N/A
JAMP-OXCARBAZEPINE	Jamp Pharma Corporation	02440725	Tablet - Oral	300 MG	6/8/2015

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OXCARBAZEPINA TEVA 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Teva Pharma S.L.U.	74158	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OXCARBAZEPINA NORMON 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	73650	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
TRILEPTAL 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Novartis Farmaceutica S.A.	63093	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
OXCARBAZEPINA NORMON 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	73651	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
OXCARBAZEPINA VIATRIS 300 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Viatris Limited	68674	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
OXCARBAZEPINA TECNIGEN 600 mg COMPRIMIDOS EFG	Tecnimede España Industria Farmaceutica S.A.	74473	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
TRILEPTAL 60 mg/ml SUSPENSION ORAL	Novartis Farmaceutica S.A.	64398	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized
OXCARBAZEPINA TECNIGEN 300 mg COMPRIMIDOS EFG	Tecnimede España Industria Farmaceutica S.A.	74472	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
TRILEPTAL 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Novartis Farmaceutica S.A.	63095	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
OXCARBAZEPINA TEVA 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Teva Pharma S.L.U.	74157	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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