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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 001
ARIPIPRAZOLE (ABILIFY MAINTENA KIT) FOR SUSPENSION, EXTENDED RELEASE 300MG/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7807680 10/19/2024 DP
001 8030313 10/19/2024 U-543 U-1632
001 8338427 03/15/2025 DP U-543 U-1633
001 8338428 08/06/2023 DP U-543 U-1633
001 8399469 06/29/2025 DS 04/15/2013
001 8722679 10/19/2024 DP 06/09/2014
001 8759351 08/06/2023 DP U-1530 U-1633 07/22/2014
001 8993761 09/25/2022 DS 04/28/2015
001 9089567 01/28/2022 U-543 08/26/2015
001 10525057 03/08/2034 U-543 U-1632 U-2723 01/31/2020
001 10980803 09/24/2033 U-543 U-1632 05/19/2021
001 11154553 09/24/2033 U-814 U-1632 U-3245 11/17/2021
001 11344547 09/24/2033 U-814 U-1632 U-3245 06/24/2022
001 11400087 09/24/2033 U-814 U-1632 U-3245 08/29/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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