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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: N021729

Product 003
ARIPIPRAZOLE (ABILIFY) TABLET, ORALLY DISINTEGRATING 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 7053092 01/28/2022 U-839
003 8017615 06/16/2024 DP
003 8017615*PED 12/16/2024
003 8580796 09/25/2022 DS
003 8580796*PED 03/25/2023
003 8642600 01/28/2022 U-1492 03/05/2014
003 8642600*PED 07/28/2022
003 8642760 09/25/2022 DS 03/05/2014
003 8642760*PED 03/25/2023
003 8759350 03/02/2027 U-1529 07/22/2014
003 9089567 01/28/2022 U-543 08/26/2015
003 9125939 07/28/2026 U-1749 10/07/2015
003 9359302 09/25/2022 DS DP U-1859 06/30/2016
003 9387182 12/25/2023 U-1529 08/02/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration



View a list of all patent use codes
View a list of all exclusivity codes

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