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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: N021196

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7668730 06/16/2024 U-1110 Y
001 7668730*PED 12/16/2024
001 8772306 03/15/2033 U-1532 07/09/2014
001 8772306*PED 09/15/2033
001 9050302 03/15/2033 U-1532 07/08/2015
001 9050302*PED 09/15/2033
001 9486426 03/15/2033 U-1532 12/06/2016
001 9486426*PED 09/15/2033
001 10213400 03/15/2033 U-2499 03/28/2019
001 10213400*PED 09/15/2033
001 10864181 03/15/2033 U-1532 01/13/2021
001 10864181*PED 09/15/2033
001 11253494 03/15/2033 U-3323 U-3324 03/15/2022
001 11253494*PED 09/15/2033

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 ODE-231 10/26/2025
001 ODE-231 *PED 04/26/2026



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

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