Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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.

Product No	Patent No	Patent Expiration	Patent Use Code	Submission Date
001	10512657	10/26/2032	U-3850	03/22/2024
001	11229647	02/12/2040	U-3290 U-3974	02/01/2022
001	11229661	10/26/2032	U-3850	03/22/2024
001	11260053	05/26/2031	U-3290 U-3974	03/01/2022
001	11376251	10/26/2032	U-3290 U-3974	07/19/2022
001	11497745	02/12/2040	U-3290 U-3974	11/30/2022
001	11918578	02/12/2040	U-3290 U-3974	03/22/2024