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	Submission Date
002	8651103	03/26/2028	DP	01/09/2019
002	8978966	01/13/2032	DP	01/09/2019
002	9216260	06/28/2031	DP	01/09/2019
002	9463288	05/19/2025	DP	01/09/2019
002	9731087	05/18/2031	DP	01/09/2019
002	9782550	08/28/2035	DP	01/09/2019
002	9782551	08/28/2035	DP	01/09/2019
002	10022510	05/18/2031	DP	01/09/2019
002	10124131	05/18/2031	DP	01/09/2019
002	10561808	01/01/2032	DP	03/19/2020
002	10569034	08/16/2036	DP	03/12/2020
002	10765820	05/19/2025	DP	10/06/2020
002	10918816	12/14/2035	DP	03/18/2021
002	11000653	12/18/2038	DP	06/10/2021
002	11173259	07/06/2040	DP	12/08/2021
002	11266796	02/22/2041	DP	04/07/2022
002	11344685	09/26/2039	DP	06/29/2022
002	11351317	02/10/2038	DP	06/29/2022
002	11357935	09/24/2038	DP	07/13/2022
002	11439777	05/24/2040	DP	10/06/2022
002	11464923	06/19/2040	DP	11/10/2022

Product No	Exclusivity Code	Exclusivity Expiration