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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: N215498

Product 004

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 7132416 09/05/2022 DS DP 08/18/2021
004 9694018 11/08/2031 U-3186 08/18/2021
004 10011633 11/08/2031 U-3186 08/18/2021
004 10093697 11/08/2031 U-3186 08/18/2021
004 10487111 11/08/2031 U-3186 U-3187 08/18/2021
004 10975046 06/20/2039 DS 08/18/2021
004 10981952 11/08/2031 U-3186 U-3187 08/18/2021
004 11365182 06/20/2039 U-3186 U-3187 07/12/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
004 NCE 07/20/2026
004 ODE-363 07/20/2028



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