Orange Book product · Brand (NDA)

APTIOM

ESLICARBAZEPINE ACETATE

Brand (NDA)NDA 022416TE ABRX SUMITOMO PHARMA AM

Nov 08, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 08, 2013
12 yr 10 mo ago
Patent 9206135 expires
Listed drug substance patent expiration.
Apr 21, 2026
2 mo ago
Patent 9643929 expires
Listed drug product patent expiration.
Apr 21, 2026
2 mo ago
Today
Patent 9763954 expires
Listed method-of-use patent (U-2123) expiration.
Sep 13, 2028
in 2 yr 3 mo
Patent 10912781 expires
Listed drug product patent expiration.
Oct 23, 2028
in 2 yr 5 mo
Patent 9566244 expires
Listed drug product patent expiration.
Oct 23, 2028
in 2 yr 5 mo
Patent 8372431 expires
Listed drug product patent expiration.
Apr 17, 2030
in 3 yr 11 mo
Patent 9750747 expires
Listed method-of-use patent (U-2041) expiration.
Aug 24, 2032
in 6 yr 3 mo
Patent 9750747 expires
Listed method-of-use patent (U-2121) expiration.
Aug 24, 2032
in 6 yr 3 mo

Active ingredient

ESLICARBAZEPINE ACETATE

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022416

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9206135	Apr 21, 2026	2 mo ago	Substance
9643929	Apr 21, 2026	2 mo ago	Product
9763954	Sep 13, 2028	in 2 yr 3 mo	U-2123
10912781	Oct 23, 2028	in 2 yr 5 mo	Product
9566244	Oct 23, 2028	in 2 yr 5 mo	Product
8372431	Apr 17, 2030	in 3 yr 11 mo	Product
9750747	Aug 24, 2032	in 6 yr 3 mo	U-2041
9750747	Aug 24, 2032	in 6 yr 3 mo	U-2121