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: N202810

Product 002
OXCARBAZEPINE (OXTELLAR XR) TABLET, EXTENDED RELEASE 300MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7722898	04/13/2027		DP
002	7910131	04/13/2027			U-2041
002	8617600	04/13/2027		DP
002	8821930	04/13/2027		DP
002	9119791	04/13/2027			U-2041		09/11/2015
002	9351975	04/13/2027		DP			06/10/2016
002	9370525	04/13/2027		DP			06/24/2016
002	9855278	04/13/2027		DP			01/05/2018
002	10220042	04/13/2027			U-2501		03/28/2019
002	11166960	04/13/2027		DP			11/24/2021
002	11896599	04/13/2027		DP			02/28/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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