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	8651103	03/26/2028	DP		01/30/2017
002	8651103*PED	09/26/2028
002	8714149	02/25/2032	DP		01/30/2017
002	8714149*PED	08/25/2032
002	8978966	01/13/2032	DP		01/30/2017
002	8978966*PED	07/13/2032
002	9066957	10/06/2034	DP	U-645	01/30/2017
002	9066957*PED	04/06/2035
002	9216260	06/28/2031	DP		01/30/2017
002	9216260*PED	12/28/2031
002	9463288	05/19/2025	DP		01/30/2017
002	9463288*PED	11/19/2025
002	9616024	09/01/2024	DP		05/10/2017
002	9616024*PED	03/01/2025
002	9731087	05/18/2031	DP		08/31/2017
002	9731087*PED	11/18/2031
002	9987229	09/01/2024	DP		07/03/2018
002	9987229*PED	03/01/2025
002	10022510	05/18/2031	DP		08/13/2018
002	10022510*PED	11/18/2031
002	10124131	05/18/2031	DP		12/12/2018
002	10124131*PED	11/18/2031
002	10195375	02/14/2031	DP		03/05/2019
002	10195375*PED	08/14/2031
002	10561808	01/01/2032	DP		03/19/2020
002	10561808*PED	07/01/2032
002	10765820	05/19/2025	DP		10/06/2020
002	10765820*PED	11/19/2025

Product No	Exclusivity Code	Exclusivity Expiration