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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: N209241

Product 001
VALBENAZINE TOSYLATE (INGREZZA) CAPSULE EQ 40MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8039627 04/11/2031 DS DP 04/26/2017
001 8357697 11/08/2027 U-1995 U-3055 04/26/2017
001 10065952 10/28/2036 DS DP U-1995 U-3055 09/26/2018
001 10844058 10/28/2036 DS DP U-1995 U-3055 12/18/2020
001 10851103 10/28/2036 DS DP U-1995 U-3055 12/18/2020
001 10851104 10/28/2036 DS U-1995 U-3055 12/18/2020
001 10857137 10/10/2037 U-1995 12/18/2020
001 10857148 10/10/2037 U-1995 12/18/2020
001 10874648 10/10/2037 U-1995 U-3046 U-3055 01/25/2021
001 10906902 12/22/2036 DS DP 03/03/2021
001 10906903 12/22/2036 DS DP 03/03/2021
001 10912771 10/10/2037 U-1995 U-3055 U-3076 03/03/2021
001 10919892 12/22/2036 DS DP 03/03/2021
001 10940141 08/10/2040 U-1995 04/06/2021
001 10952997 10/10/2037 U-1995 04/06/2021
001 10993941 10/10/2037 U-1995 05/19/2021
001 11026931 08/14/2039 U-1995 06/30/2021
001 11026939 09/18/2038 DP U-1995 U-3055 06/30/2021
001 11040029 10/10/2037 U-1995 06/30/2021
001 11311532 09/18/2038 DP U-1995 U-3055 05/17/2022
001 11439629 10/10/2037 U-3055 09/14/2023
001 11654142 11/14/2038 U-3055 09/14/2023

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-925 08/18/2026
001 ODE-440 08/18/2030

 

 


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