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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: N209091

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6515117 10/04/2025 DS DP U-493 03/22/2017
001 7919598 12/16/2029 DS 03/22/2017
001 8221786 03/21/2028 DP 03/22/2017
001 8361972 03/21/2028 U-493 U-1976 U-1977 03/22/2017
001 8501698 06/20/2027 DP U-493 U-1976 U-1977 03/22/2017
001 8628799 07/13/2025 DP 03/22/2017
001 8716251 03/21/2028 DP 03/22/2017
001 RE44186 07/31/2023 DS DP U-493 03/22/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-804 05/02/2022



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

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