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: N202123

Product 001
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE (COMPLERA) TABLET 200MG;EQ 25MG BASE;300MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6642245*PED 05/04/2021
001 6703396 03/09/2021 DS DP
09/06/2011
001 6703396*PED 09/09/2021
001 6838464 02/26/2021 DS DP
09/06/2011
001 7125879 04/21/2025 DS DP
U-257 TREATMENT OF HIV INFECTION
09/06/2011
001 8080551 04/11/2023 DS DP
06/15/2012
001 8101629 08/09/2022 DP
06/15/2012
001 8592397 01/13/2024 DP
U-257 TREATMENT OF HIV INFECTION
001 8716264 01/13/2024 DP
U-257 TREATMENT OF HIV INFECTION
05/30/2014
001 8841310 12/09/2025 DP
U-257 TREATMENT OF HIV INFECTION
10/20/2014
001 9457036 01/13/2024 DP
U-257 TREATMENT OF HIV INFECTION
11/10/2016
001 9744181 01/13/2024 DP
U-257 TREATMENT OF HIV INFECTION
09/19/2017
001 10857102 01/14/2033 DP
01/06/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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