Oxcarbazepine

Treats partial-onset seizures. Sold as Trileptal, Oxtellar Xr. Every FDA application for this active ingredient: 3 branded and 37 generic.

As of Nov 15, 2026, FDA lists 40 applications for Oxcarbazepine (sold as Trileptal, Oxtellar Xr), first approved Jan 14, 2000, with 4 new uses approved and 0 published complete response letters.

First approved: Jan 14, 2000
Applications: 40
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $122M
First approved in Japan: Jul 4, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Oxcarbazepine	Part D	$75.9M	+12%	205,566
Trileptal	Part D	$18.8M	-3%	1,489
Oxtellar XR	Part D	$14.5M	-49%	1,468
Oxcarbazepine ER	Part D	$13.0M	+410%	2,573

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

OXCARBAZEPINE 150 MG TABLET: $0.107 per unitGeneric · -10% in a year
OXCARBAZEPINE 300 MG TABLET: $0.171 per unitGeneric · 0% in a year
OXCARBAZEPINE 300 MG/5 ML SUSP: $0.116 per MLGeneric · -27% in a year
OXCARBAZEPINE 600 MG TABLET: $0.318 per unitGeneric · -7% in a year
OXCARBAZEPINE ER 150 MG TABLET: $3.41 per unitGeneric · -42% in a year
OXCARBAZEPINE ER 300 MG TABLET: $4.91 per unitGeneric · -43% in a year
OXCARBAZEPINE ER 600 MG TABLET: $9.38 per unitGeneric · -40% in a year
TRILEPTAL 150 MG TABLET: $5.72 per unitBrand · +3% in a year
TRILEPTAL 300 MG TABLET: $10.45 per unitBrand · +3% in a year
TRILEPTAL 300 MG/5 ML SUSP: $1.93 per MLBrand · +3% in a year
TRILEPTAL 600 MG TABLET: $19.33 per unitBrand · +3% in a year
OXTELLAR XR 150 MG TABLET: $9.03 per unitBrand · -2% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaseMar 31, 2021

Approvals in Japan (PMDA)

First approved in Japan 198 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Ocnobel, new ingredientDrugs with a new active ingredient indicated for the use as an adjunctive therapy with other antiepileptic drugs to treat partial seizures (including… · Nobelpharma Co., Ltd. · Jul 4, 2016

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026
Prospective Study of Eslicarbazepine in Adults With Focal-Onset SeizuresFocal-Onset Seizures · King Edward Medical University	—	Recruiting	Aug 28, 2026
Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal NeuralgiaTrigeminal Neuralgia · Abbasi Shaheed Hospital	Not applicable	Active, not recruiting	Nov 26, 2025
Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal NeuralgiaTrigeminal Neuralgia · Jinnah Postgraduate Medical Centre	Phase 4	Active, not recruiting	Feb 27, 2025
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and BreastfeedingEpilepsy, Pregnancy Related · University of Pittsburgh	—	Recruiting	Jul 11, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 14, 2000	TrileptalNDA 21014 · New molecular entity	Novartis	34	Marketed
May 25, 2001	TrileptalNDA 21285 · New dosage form	Novartis	26	Marketed
Oct 9, 2007	OxcarbazepineANDA 77794	Sun Pharm Inds	7	Marketed
Oct 9, 2007	OxcarbazepineANDA 77802	Glenmark Pharms Ltd	10	Marketed
Oct 9, 2007	OxcarbazepineANDA 77795	Hikma	6	Discontinued
Nov 15, 2007	OxcarbazepineANDA 77801	Taro	3	Marketed
Dec 11, 2007	OxcarbazepineANDA 78005	Ani Pharms	7	Marketed
Jan 11, 2008	OxcarbazepineANDA 78069	Breckenridge Pharm	11	Marketed
Apr 9, 2008	OxcarbazepineANDA 77747	Rubicon Research	9	Marketed
Jun 26, 2009	OxcarbazepineANDA 78734	Sun Pharm Inds Ltd	7	Marketed
Jan 25, 2010	OxcarbazepineANDA 90239	Jubilant Cadista	2	Discontinued
Sep 17, 2012	OxcarbazepineANDA 202961	Amneal Pharms	7	Marketed
Oct 3, 2012	OxcarbazepineANDA 201193	Hikma	5	Discontinued
Oct 19, 2012	Oxtellar XrNDA 202810 · New dosage form	Supernus Pharms	9	Marketed
Jun 21, 2021	OxcarbazepineANDA 212428	Chartwell Rx	3	Marketed
Jul 9, 2021	OxcarbazepineANDA 211420	Pai Holdings	0	Discontinued
Jan 11, 2022	OxcarbazepineANDA 215939	Annora Pharma	2	Marketed
Aug 30, 2022	OxcarbazepineANDA 215726	Rubicon Research	0	Marketed
Nov 4, 2022	OxcarbazepineANDA 209652	Bionpharma	2	Marketed
Nov 30, 2022	OxcarbazepineANDA 215332	Aucta	3	Marketed
Jul 3, 2023	OxcarbazepineANDA 211747	Zydus	2	Discontinued
Jul 13, 2023	OxcarbazepineANDA 213369	Apotex	0	Marketed
Oct 20, 2023	OxcarbazepineANDA 216749	Hetero Labs Ltd Iii	2	Marketed
Feb 14, 2024	OxcarbazepineANDA 217782	Pharmazone	1	Marketed
Feb 22, 2024	OxcarbazepineANDA 217659	Ajanta Pharma Ltd	1	Marketed
Mar 1, 2024	OxcarbazepineANDA 218278	Biocon Pharma	2	Marketed
Mar 5, 2024	OxcarbazepineANDA 207717	Rubicon Research	1	Marketed
Mar 18, 2024	OxcarbazepineANDA 213183	Alkem Labs Ltd	1	Marketed
Nov 22, 2024	OxcarbazepineANDA 215796	Riconpharma LLC	0	Marketed
Apr 30, 2025	OxcarbazepineANDA 219241	Aurobindo Pharma Ltd	0	Marketed
Jul 11, 2025	OxcarbazepineANDA 207300	Macleods Pharms	0	Marketed
Mar 2, 2026	OxcarbazepineANDA 219556	Epic Pharma LLC	0	Marketed
Mar 9, 2026	OxcarbazepineANDA 220281	Adaptis	0	Discontinued
Apr 29, 2026	OxcarbazepineANDA 218341	Umedica Labs Pvt	0	Marketed
May 29, 2026	OxcarbazepineANDA 209020	Msn	0	Marketed
—	OxcarbazepineANDA 206576	Twi Pharms Inc	0	Discontinued
—	OxcarbazepineANDA 218442	Biocon Pharma Ltd	0	Discontinued
—	OxcarbazepineANDA 218724	Novast Labs Ltd	0	Discontinued
—	Oxcarbazepine Extended Release TabletsANDA 219404	Lupin Limited	0	Discontinued
—	OxcarbazepineANDA 205444	Actavis Labs Fl Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA