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	Drug Product	Patent Use Code	Submission Date
001	8357714	08/26/2031		U-2849	07/14/2020
001	9867808	08/26/2031		U-2849	07/14/2020
001	10799481	12/16/2039		U-2849	10/20/2020
001	10814001	12/16/2039	DP		11/02/2020
001	10898573	12/16/2039	DP		01/27/2021
001	10912765	08/26/2031		U-2849	02/10/2021
001	10940138	12/16/2039		U-2849	03/10/2021
001	11103482	12/16/2039	DP		09/10/2021
001	11311515	12/16/2039	DP		05/03/2022
001	11324722	12/16/2039		U-2849	05/11/2022
001	11541036	12/16/2039	DP		01/05/2023
001	11701343	12/16/2039		U-2849	11/07/2023

Product No	Exclusivity Code	Exclusivity Expiration