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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: N205834

Product 001
LEDIPASVIR; SOFOSBUVIR (HARVONI) TABLET 90MG;400MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7964580 03/26/2029 DS DP U-1470 10/30/2014
001 7964580*PED 09/26/2029
001 8088368 05/12/2030 DS DP 10/30/2014
001 8088368*PED 11/12/2030
001 8273341 05/12/2030 U-1470 10/30/2014
001 8273341*PED 11/12/2030
001 8334270 03/21/2028 DS DP U-1470 10/30/2014
001 8334270*PED 09/21/2028
001 8580765 03/21/2028 DS DP U-1470 10/30/2014
001 8580765*PED 09/21/2028
001 8618076 12/11/2030 DS DP U-1470 10/30/2014
001 8618076*PED 06/11/2031
001 8633309 03/26/2029 DS DP U-1470 10/30/2014
001 8633309*PED 09/26/2029
001 8735372 03/21/2028 U-1470 10/30/2014
001 8735372*PED 09/21/2028
001 8822430 05/12/2030 DS DP U-1470 10/30/2014
001 8822430*PED 11/12/2030
001 8841278 05/12/2030 DP U-1470 10/30/2014
001 8841278*PED 11/12/2030
001 8889159 03/26/2029 DP U-1470 12/11/2014
001 8889159*PED 09/26/2029
001 9085573 03/21/2028 DS DP U-1470 08/11/2015
001 9085573*PED 09/21/2028
001 9284342 09/13/2030 DS DP U-1470 04/12/2016
001 9284342*PED 03/13/2031
001 9393256 09/14/2032 U-1470 08/15/2016
001 9393256*PED 03/14/2033
001 9511056 05/12/2030 DP U-1470 01/05/2017
001 9511056*PED 11/12/2030
001 10039779 01/30/2034 DS DP U-2369 U-2370 08/29/2018
001 10039779*PED 07/30/2034
001 10456414 09/14/2032 DP 11/20/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 ODE-136 04/07/2024
001 ODE-136 *PED 10/07/2024
001 ODE* 08/28/2026

 

 


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