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 Substance	Drug Product	Patent Use Code	Submission Date
001	7288657	12/23/2025	DS			11/20/2018
001	7491736	03/10/2025			U-2440	11/20/2018
001	7521041	03/10/2025			U-2440	11/20/2018
001	7550595	03/10/2025		DP		11/20/2018
001	7585879	03/10/2025	DS	DP	U-2440	11/20/2018
001	7910608	03/10/2025	DS	DP		11/20/2018
001	8034946	03/10/2025		DP		11/20/2018
001	8053448	03/10/2025			U-2440	11/20/2018
001	8273894	03/10/2025		DP		11/20/2018
001	8541451	08/25/2031	DS			05/31/2019
001	9765028	07/14/2030	DS			05/31/2019
001	10106503	03/10/2025			U-2440	11/20/2018
001	10343995	03/10/2025			U-2440	07/15/2019
001	10550081	07/14/2030	DS			02/10/2020
001	11008289	07/14/2030			U-2440	05/20/2021
001	11247969	03/10/2025		DP		03/03/2022
001	11484531	10/23/2039			U-2440	11/02/2022
001	11691948	07/14/2030		DP		07/05/2023
001	11858898	07/14/2030	DS	DP	U-2440	01/02/2024

Product No	Exclusivity Code	Exclusivity Expiration