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: N202971

Product 003
ARIPIPRAZOLE (ABILIFY MAINTENA KIT) FOR SUSPENSION, EXTENDED RELEASE 300MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	7807680	10/19/2024		DP
003	8030313	10/19/2024			U-543 U-1632
003	8338427	03/15/2025		DP	U-543 U-1633
003	8399469	06/29/2025	DS
003	8722679	10/19/2024		DP
003	10525057	03/08/2034			U-543 U-1632 U-2723		01/31/2020
003	10980803	09/24/2033			U-543 U-1632		05/19/2021
003	11154553	09/24/2033			U-814 U-1632 U-3245		11/17/2021
003	11344547	09/24/2033			U-814 U-1632 U-3245		06/24/2022
003	11400087	09/24/2033			U-814 U-1632 U-3245		08/29/2022
003	11648347	04/06/2034		DP			06/15/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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View a list of all exclusivity codes