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
002	8021335	10/04/2026	DP		10/24/2018
002	8562564	01/24/2026	DP		10/24/2018
002	9180259	01/24/2026	DP		10/24/2018
002	9533102	01/24/2026	DP		10/24/2018
002	9629959	01/24/2026	DP		10/24/2018
002	9744302	11/19/2035	DP		10/24/2018
002	9950125	09/04/2036	DP	U-2418	10/24/2018
002	10238662	02/19/2035	DP	U-2418	06/11/2020
002	10279131	07/31/2031	DP		06/11/2020
002	10357609	08/21/2031	DP		06/11/2020
002	10478560	01/24/2026	DP		06/11/2020
002	10646495	08/30/2038	DP		06/11/2020
002	10821072	06/04/2033	DP	U-2418	11/23/2020
002	10881798	02/11/2034	DP		02/04/2021
002	10905827	08/21/2031	DP		03/02/2021
002	10912782	02/19/2035	DP	U-2418	03/02/2021
002	11160751	10/07/2034	DP	U-2418	01/06/2022
002	11191908	10/18/2035	DP		01/06/2022
002	11446440	08/21/2031	DP		10/07/2022
002	11446441	01/24/2026	DP		10/07/2022
002	11497753	03/19/2030	DP		12/14/2022
002	11813435	02/25/2035	DP		11/22/2023
002	11844804	06/04/2033		U-2418	01/18/2024

Product No	Exclusivity Code	Exclusivity Expiration