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: N208215

Product 001
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) TABLET 200MG;EQ 25MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6642245 11/04/2020
U-257 TREATMENT OF HIV INFECTION
05/02/2016
001 6642245*PED 05/04/2021
001 6703396 03/09/2021 DS DP
05/02/2016
001 6703396*PED 09/09/2021
001 7390791 05/07/2022 DS DP
05/02/2016
001 7803788 02/02/2022
U-257 TREATMENT OF HIV INFECTION
05/02/2016
001 8754065 08/15/2032 DS DP
U-257 TREATMENT OF HIV INFECTION
05/02/2016
001 9296769 08/15/2032 DS DP
U-257 TREATMENT OF HIV INFECTION
04/26/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPP NEW PATIENT POPULATION
COMPETITIVE GENERIC THERAPY
09/25/2020
001
NCE NEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
11/05/2020

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