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
002	7741356	05/27/2029	DS	DP		06/26/2015
002	7786158	03/14/2025	DS			06/26/2015
002	8344011	03/14/2025			U-1709	06/26/2015
002	8609709	03/14/2025	DS			06/26/2015
002	8691860	07/07/2028	DS		U-1709	06/26/2015
002	8772325	03/14/2025			U-1709	02/16/2017
002	9115091	07/07/2028	DS	DP	U-1738	09/23/2015
002	9205076	03/14/2025			U-1709	12/30/2015
002	9364489	07/07/2028			U-1709	07/14/2016
002	9675587	03/14/2033		DP		08/07/2017
002	9700542	03/14/2025		DP		08/07/2017
002	9789125	07/07/2028		DP	U-1709 U-2152	11/01/2017
002	10188632	03/14/2033		DP		02/28/2019
002	10213415	03/14/2025	DS		U-2152	03/21/2019
002	11007179	03/14/2033		DP		06/03/2021
002	11090291	03/14/2033		DP		09/07/2021
002	11160792	03/14/2033		DP		11/24/2021
002	11229627	03/14/2033		DP		02/15/2022
002	11311516	03/14/2033		DP		05/19/2022
002	11484527	03/14/2033			U-3475	11/22/2022

Product No	Exclusivity Code	Exclusivity Expiration