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FDA Orange Book · active-ingredient family

Eslicarbazepine acetate

Eslicarbazepine acetate is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:APTIOM · NDA 022416

1

Brand (NDA)

8

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
APTIOMRLD×4SUMITOMO PHARMA AMNDA 022416ABNov 08, 2013

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
ESLICARBAZEPINE ACETATE×4SPH ZHONGXI PHARMANDA 211247ABNov 03, 2025
ESLICARBAZEPINE ACETATE×4JUBILANT GENERICSANDA 211219ABAug 04, 2025
ESLICARBAZEPINE ACETATE×4LUPINANDA 211246ABMar 27, 2024
ESLICARBAZEPINE ACETATE×4TORRENTANDA 211227ABFeb 27, 2024
ESLICARBAZEPINE ACETATE×4APOTEXANDA 211236ABDec 07, 2023
ESLICARBAZEPINE ACETATE×4ALKEM LABS LTDANDA 211199ABOct 06, 2023
ESLICARBAZEPINE ACETATE×4HETERO LABS LTD VANDA 211186ABAug 03, 2023
ESLICARBAZEPINE ACETATE×4DR REDDYSANDA 211238ABJun 29, 2021

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9206135Apr 21, 20262 mo ago
Substance
9643929Apr 21, 20262 mo ago
Product
9763954Sep 13, 2028in 2 yr 3 mo
U-2123
9566244Oct 23, 2028in 2 yr 5 mo
Product
10912781Oct 23, 2028in 2 yr 5 mo
Product
8372431Apr 17, 2030in 3 yr 11 mo
Product
9750747Aug 24, 2032in 6 yr 3 mo
U-2041

Eslicarbazepine acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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