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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: N215727

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9744144 11/01/2033 U-3643 06/29/2023
001 10130585 05/09/2034 U-3642 06/29/2023
001 10206891 11/01/2033 U-3641 06/29/2023
001 10265281 11/01/2033 U-3639 06/29/2023
001 10842762 11/01/2033 U-3640 06/29/2023
001 11026899 11/01/2033 U-3639 06/29/2023
001 11026900 11/01/2033 U-3639 06/29/2023
001 11026901 11/01/2033 U-3638 06/29/2023
001 11944594 11/01/2033 U-3864 04/03/2024
001 11944595 11/01/2033 U-3867 U-3868 04/05/2024

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration



View a list of all patent use codes
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