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: N210192

Product 001
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE (JULUCA) TABLET EQ 50MG BASE;EQ 25MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6838464 02/26/2021 DS DP
12/20/2017
001 7125879 04/21/2025 DS DP
U-257 TREATMENT OF HIV INFECTION
12/20/2017
001 8080551 04/11/2023 DS DP
12/20/2017
001 8101629 08/09/2022 DP
12/20/2017
001 8129385 10/05/2027 DS DP
12/20/2017
001 9242986 12/08/2029 DS DP
12/20/2017
001 10426780 01/24/2031 DS DP
U-257 TREATMENT OF HIV INFECTION
10/25/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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