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: N210793

Product 001
PIMAVANSERIN TARTRATE (NUPLAZID) CAPSULE EQ 34MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6756393 03/06/2021 DS DP
07/25/2018
001 6815458 03/06/2021 DS DP
U-1843 TREATMENT OF PSYCHOSIS
07/25/2018
001 7115634 10/06/2021 DS DP
07/25/2018
001 7601740 06/17/2027 DS DP
07/25/2018
001 7659285 08/24/2026
U-1844 TREATMENT OF PARKINSON'S DISEASE PSYCHOSIS
07/25/2018
001 7732615 06/03/2028 DS DP
07/25/2018
001 7923564 09/26/2025 DS DP
07/25/2018
001 8618130 01/15/2024
U-1845 TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF
07/25/2018
001 8921393 01/15/2024
U-1846 TREATMENT OF A NEURODEGENERATIVE DISEASE OR A SYMPTOM THEREOF
07/25/2018
001 9296694 03/06/2021 DS DP
07/25/2018
001 9566271 01/15/2024
U-1974 TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
07/25/2018
001 9765053 07/27/2022
U-1974 TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
07/25/2018
001 10028944 01/15/2024
U-1974 TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
07/25/2018
001 10449185 08/27/2038 DP
11/01/2019
001 10646480 08/27/2038 DP
05/15/2020
001 10849891 08/27/2038 DP
U-1974 TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
12/11/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
04/29/2021

 

 


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