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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: N214275

Product 001
SELEXIPAG (UPTRAVI) POWDER 1.8MG/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7205302 10/31/2026 DS DP U-1797 08/27/2021
001 8791122 08/01/2030 DS DP 08/27/2021
001 9173881 08/12/2029 U-1798 08/27/2021
001 9284280 06/25/2030 U-1831 08/27/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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View a list of all exclusivity codes

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