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	7994214	08/30/2024	DP		08/24/2015
001	8486993	08/30/2024	DP	U-1752	08/24/2015
001	8586084	08/30/2024		U-1752	08/24/2015
001	8591946	08/30/2024	DP		08/24/2015
001	8617599	08/30/2024	DP		08/24/2015
001	8623410	08/30/2024	DP		08/24/2015
001	8623411	08/30/2024		U-1752	08/24/2015
001	8664239	08/30/2028		U-1752 U-2677 U-2678	08/24/2015
001	8685998	08/30/2028	DP	U-1752 U-2677 U-2678	08/24/2015
001	8889185	08/30/2024		U-1752	08/24/2015
001	8889186	08/30/2024		U-1752	08/24/2015
001	9161907	08/30/2024	DP	U-1752	11/13/2015
001	9549918	05/30/2028	DP		05/02/2017
001	9757362	08/30/2024	DP		12/20/2017
001	9763920	08/30/2024	DP		12/20/2017
001	10166190	05/30/2028	DP		02/14/2019
001	10548880	08/30/2024		U-2677 U-2678	07/28/2020
001	10864199	05/30/2028		U-2677 U-2678	01/06/2021
001	11077096	08/30/2024	DP		07/08/2022
001	11110081	05/30/2028		U-2678	09/16/2021
001	11123331	05/30/2028		U-2677	09/28/2021
001	11419823	05/30/2028	DP		08/24/2022

Product No	Exclusivity Code	Exclusivity Expiration