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 005
ARIPIPRAZOLE (ABILIFY) TABLET, ORALLY DISINTEGRATING 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
005 7053092 01/28/2022
U-839 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
005 8017615 06/16/2024 DP
005 8017615*PED 12/16/2024
005 8518421 01/24/2021 DP
09/26/2013
005 8518421*PED 07/24/2021
005 8580796 09/25/2022 DS
005 8580796*PED 03/25/2023
005 8642600 01/28/2022
U-1492 TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
03/05/2014
005 8642600*PED 07/28/2022
005 8642760 09/25/2022 DS
03/05/2014
005 8642760*PED 03/25/2023
005 9359302 09/25/2022 DS DP
U-1859 TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
06/30/2016
005 9387182 12/25/2023
U-1529 ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
08/02/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
005
ODE-80TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
COMPETITIVE GENERIC THERAPY
12/12/2021

 

 


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