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 004
ARIPIPRAZOLE (ABILIFY MAINTENA KIT) FOR SUSPENSION, EXTENDED RELEASE 400MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 7807680 10/19/2024 DP
10/29/2014
004 8030313 10/19/2024
U-543 TREATMENT OF SCHIZOPHRENIA
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
004 8338427 03/15/2025 DP
U-543 TREATMENT OF SCHIZOPHRENIA
U-1633 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
004 8338428 08/06/2023 DP
U-543 TREATMENT OF SCHIZOPHRENIA
U-1633 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
004 8399469 06/29/2025 DS
10/29/2014
004 8722679 10/19/2024 DP
10/29/2014
004 8759351 08/06/2023 DP
U-1530 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION
U-1633 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
07/22/2014
004 8993761 09/25/2022 DS
04/28/2015
004 9089567 01/28/2022
U-543 TREATMENT OF SCHIZOPHRENIA
08/26/2015
004 10525057 03/08/2034
U-543 TREATMENT OF SCHIZOPHRENIA
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
U-2723 MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER
01/31/2020
004 10980803 09/24/2033
U-543 TREATMENT OF SCHIZOPHRENIA
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA
05/19/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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