FDA Orange Book · active-ingredient family
Eslicarbazepine acetate
Eslicarbazepine acetate: 1 brand, 8 generics; first approved Nov 08, 2013; generic available.
Generic available
Generic status & protection
Generic available: 8 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
7
Next patent expiry
Apr 21, 2026
4 mo ago
Brand (NDA) products
Originator applications
- APTIOMRLDSUMITOMO PHARMA AMNDA 02241620134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- ESLICARBAZEPINE ACETATESPH ZHONGXI PHARMANDA 21124720254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATEJUBILANT GENERICSANDA 21121920254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATELUPINANDA 21124620244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATETORRENTANDA 21122720244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATEAPOTEXANDA 21123620234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATEALKEM LABS LTDANDA 21119920234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATEHETERO LABS LTD VANDA 21118620234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB - ESLICARBAZEPINE ACETATEDR REDDYSANDA 21123820214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 800MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9206135 | 4 mo ago | Substance | |
| 9643929 | 4 mo ago | Product | |
| 9763954 | in 2 yr 1 mo | U-2123 | |
| 9566244 | in 2 yr 2 mo | Product | |
| 10912781 | in 2 yr 2 mo | Product | |
| 8372431 | in 3 yr 8 mo | Product | |
| 9750747 | in 6 yr 1 mo | U-2041 |
Approval history
FDA approval span
First approval
13 yr ago
Most recent approval
10 mo ago
Approvals span 2013–2025 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Eslicarbazepine acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
