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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: N022369

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8038988 08/25/2023 DS DP U-1208 10/31/2011
001 8101161 05/25/2024 U-1217 U-1218 05/10/2012
001 8263054 01/15/2023 U-1277 09/17/2012
001 8632760 01/15/2023 U-1487 02/21/2014
001 8758733 01/15/2023 U-1487 07/16/2014
001 8986715 01/15/2023 U-1217 04/01/2015
001 9216183 01/15/2023 U-1487 01/20/2016
001 9226931 01/15/2023 U-1799 01/20/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration



View a list of all patent use codes
View a list of all exclusivity codes

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