Eslicarbazepine Acetate

Treats partial-onset seizures. Sold as Aptiom. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 15, 2026, FDA lists 10 applications for Eslicarbazepine Acetate (sold as Aptiom), first approved Nov 8, 2013, with 3 new uses approved and 0 published complete response letters.

First approved: Nov 8, 2013
Applications: 10
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $111M
First approved in the EU: Apr 21, 2009

Medicare Spending

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


Aptiom	Part D	$92.0M	-36%	7,100
Eslicarbazepine Acetate	Part D	$19.5M	New	5,537

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

ESLICARBAZEPINE 200 MG TABLET: $1.77 per unitGeneric · -47% in a year
ESLICARBAZEPINE 400 MG TABLET: $1.67 per unitGeneric · -59% in a year
ESLICARBAZEPINE 600 MG TABLET: $1.62 per unitGeneric · -66% in a year
ESLICARBAZEPINE 800 MG TABLET: $1.52 per unitGeneric · -61% in a year
APTIOM 200 MG TABLET: $44.24 per unitBrand · +3% in a year
APTIOM 400 MG TABLET: $44.01 per unitBrand · +2% in a year
APTIOM 600 MG TABLET: $44.43 per unitBrand · +3% in a year
APTIOM 800 MG TABLET: $44.08 per unitBrand · +3% 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 the EU (EMA)

First approved in the EU 55 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Zebinix, new substanceBIAL - Portela & Ca, S.A. · Apr 21, 2009
ExaliefBIAL - Portela Ca, S.A. · Apr 21, 2009 · lapsed

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Prospective Study of Eslicarbazepine in Adults With Focal-Onset SeizuresFocal-Onset Seizures · King Edward Medical University	—	Recruiting	Aug 28, 2026

Applications

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


Nov 8, 2013	AptiomNDA 22416 · New molecular entity	Sumitomo Pharma Am	8	Marketed
Jun 29, 2021	Eslicarbazepine AcetateANDA 211238	Dr Reddys	0	Marketed
Aug 3, 2023	Eslicarbazepine AcetateANDA 211186	Hetero Labs Ltd V	0	Marketed
Oct 6, 2023	Eslicarbazepine AcetateANDA 211199	Alkem Labs Ltd	0	Marketed
Dec 7, 2023	Eslicarbazepine AcetateANDA 211236	Apotex	0	Marketed
Feb 27, 2024	Eslicarbazepine AcetateANDA 211227	Torrent	0	Marketed
Mar 27, 2024	Eslicarbazepine AcetateANDA 211246	Lupin	0	Marketed
Aug 4, 2025	Eslicarbazepine AcetateANDA 211219	Jubilant Generics	0	Marketed
Nov 3, 2025	Eslicarbazepine AcetateANDA 211247	Sph Zhongxi Pharm	0	Marketed
Aug 5, 2026	Eslicarbazepine AcetateANDA 216481	Aurobindo Pharma	0	Marketed

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