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: N211243

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8785500 03/05/2033 U-2502 04/03/2019
001 9592207 03/20/2027 U-2502 04/03/2019
001 10869844 09/10/2035 U-3034 U-3035 U-3036 01/15/2021
001 11173134 09/10/2035 U-3257 U-3536 12/16/2021
001 11311500 09/10/2035 U-3034 U-3035 U-3036 05/26/2022
001 11446260 03/14/2034 U-3444 U-3445 U-3446 10/14/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-840 07/31/2023
001 NCE* 03/05/2024



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

Back to Top