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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: N217686

Product 001
APROCITENTAN (TRYVIO) TABLET 12.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8324232 09/21/2029 DS DP U-3878 04/16/2024
001 10919881 02/26/2038 DS DP 04/16/2024
001 11174247 11/06/2037 U-3879 04/16/2024
001 11680058 07/26/2038 U-3878 04/16/2024
001 11787782 03/02/2038 U-3877 04/16/2024

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NCE 03/22/2029

 

 


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