Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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  • 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: N208624

Product 001
DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR (VIEKIRA XR) TABLET, EXTENDED RELEASE EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8188104 05/17/2029 DS DP
U-1636 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
08/17/2016
001 8268349 08/25/2024 DP
08/17/2016
001 8399015 08/25/2024 DP
08/17/2016
001 8420596 04/10/2031 DS DP
08/17/2016
001 8466159 09/04/2032
U-1637 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
08/17/2016
001 8492386 09/04/2032
U-1840 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
08/17/2016
001 8501238 09/17/2028 DS DP
U-1636 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
08/17/2016
001 8642538 09/10/2029 DS DP
U-1638 TREATMENT OF HCV INFECTION USING PARITAPREVIR
08/17/2016
001 8680106 09/04/2032
U-1637 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
08/17/2016
001 8685984 09/04/2032
U-1840 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
08/17/2016
001 8686026 06/09/2031 DP
08/17/2016
001 8691938 04/13/2032 DS DP
08/17/2016
001 9006387 06/10/2030
U-1687 TREATMENT OF HCV INFECTION USING OMBITASVIR
08/17/2016
001 9044480 04/10/2031
U-1638 TREATMENT OF HCV INFECTION USING PARITAPREVIR
08/17/2016
001 9139536 11/09/2028
U-1753 TREATMENT OF HCV INFECTION USING DASABUVIR
08/17/2016
001 9333204 01/02/2035 DP
U-1889 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
08/17/2016
001 9744170 01/02/2035 DP
U-1889 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
09/27/2017
001 10105365 01/02/2035 DP
U-1889 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
11/20/2018
001 10201541 05/17/2032 DP
03/14/2019
001 10201584 05/17/2032
U-1889 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
03/14/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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