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: N207533

Product 004
ARIPIPRAZOLE LAUROXIL (ARISTADA) SUSPENSION, EXTENDED RELEASE 1064MG/3.9ML (272.82MG/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
004	8431576	10/26/2030	DS				06/27/2017
004	8796276	06/24/2030			U-543		06/27/2017
004	9034867	11/07/2032		DP	U-543		06/27/2017
004	9193685	10/24/2033		DP	U-543		06/27/2017
004	9452131	03/19/2035			U-2402		06/27/2017
004	10112903	06/24/2030	DS		U-543		11/20/2018
004	10226458	03/19/2032			U-543		04/08/2019
004	10238651	03/19/2035			U-2402		04/08/2019
004	10813928	03/19/2035			U-2983		11/10/2020
004	11097006	10/24/2033		DP	U-764		10/21/2021
004	11273158	04/06/2039			U-543		04/13/2022
004	11406632	03/19/2035			U-2402		08/19/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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