U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N210583

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8512727 12/25/2022 DP U-2750 03/06/2020
001 9974746 05/26/2030 DP 03/06/2020
001 10463673 02/24/2024 DP U-2750 03/06/2020
001 10471067 02/24/2024 DP U-2750 03/06/2020
001 10709713 05/26/2030 U-2750 07/24/2020
001 10881663 03/08/2039 U-3038 01/19/2021
001 11253478 05/26/2030 DP U-3318 03/04/2022
001 11458145 03/08/2039 U-3318 10/25/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NP 02/20/2023



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

Back to Top