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: N022145

Product 002
RALTEGRAVIR POTASSIUM (ISENTRESS HD) TABLET EQ 600MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7169780 10/03/2023 DS DP
06/23/2017
002 7169780*PED 04/03/2024
002 7217713 10/21/2022
U-257 TREATMENT OF HIV INFECTION
06/23/2017
002 7217713*PED 04/21/2023
002 7435734 10/21/2022
U-257 TREATMENT OF HIV INFECTION
U-900 INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
06/23/2017
002 7435734*PED 04/21/2023
002 7754731 03/11/2029 DS DP
U-257 TREATMENT OF HIV INFECTION
06/23/2017
002 7754731*PED 09/11/2029
002 9649311 10/21/2030 DP
06/23/2017
002 9649311*PED 04/21/2031
002 10772888 03/30/2032
U-1663 TREATMENT OF HIV-1 INFECTION
10/27/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NPPNEW PATIENT POPULATION
*PED PEDIATRIC EXCLUSIVITY
05/22/2021

 

 


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