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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: N213378

Product 002

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7262298 11/23/2025 DS 06/25/2021
002 8778960 02/13/2032 U-3136 U-3137 06/25/2021
002 9119848 08/30/2031 DS 06/25/2021
002 9126977 08/23/2031 DP U-3136 U-3137 06/25/2021
002 9517235 08/23/2031 U-3138 U-3139 06/25/2021
002 10300054 08/23/2031 DP U-3140 U-3141 06/25/2021
002 10716785 08/23/2031 U-3136 U-3137 06/25/2021
002 11185541 08/23/2031 U-3140 12/22/2021
002 11241425 08/23/2031 U-3137 03/03/2022
002 11351166 08/23/2031 U-3140 U-3141 07/11/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002 NCE 05/28/2026



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