Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N022416

Product 003
ESLICARBAZEPINE ACETATE (APTIOM) TABLET 600MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	8372431	04/17/2030		DP
003	9206135	04/21/2026	DS				05/20/2016
003	9566244	10/23/2028		DP			03/08/2017
003	9643929	04/21/2026		DP			06/08/2017
003	9750747	08/24/2032			U-2041 U-2121		09/28/2017
003	9763954	09/13/2028			U-2123		10/10/2017
003	10675287	05/06/2025			U-2041 U-2831		06/10/2020
003	10695354	05/06/2025			U-2501 U-2831		06/30/2020
003	10702536	05/06/2025			U-2501		07/07/2020
003	10912781	10/23/2028		DP			02/10/2021
003	11364247	05/06/2025			U-2501 U-2831		06/23/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

View a list of all patent use codes
View a list of all exclusivity codes