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: N021752

Product 002
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) TABLET 100MG;150MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6642245 11/04/2020
U-248 TREATMENT OF HIV
U-541 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
U-1170 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
03/31/2016
002 6642245*PED 05/04/2021
002 6703396 03/09/2021 DS DP
03/31/2016
002 6703396*PED 09/09/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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