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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: N207981

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9527833 06/17/2034 DS DP 01/27/2017
001 9943537 09/05/2034 U-3659 08/07/2023
001 10456399 02/03/2037 U-3657 U-3658 11/08/2019
001 10457666 06/17/2034 DS DP 11/08/2019
001 10960004 02/03/2037 U-3657 U-3658 04/09/2021
001 RE46284 09/22/2029 U-1751 U-2503 U-3656 02/07/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 ODE-229 02/22/2026



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