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	9561251	01/23/2030	DP	U-1468	03/02/2017
001	9561251*PED	07/23/2030
001	10624855	11/26/2034	DP		04/27/2020
001	10624855*PED	05/26/2035
001	10682376	11/13/2028	DP		06/17/2020
001	10682376*PED	05/13/2029
001	10695367	11/13/2028	DP		07/01/2020
001	10695367*PED	05/13/2029
001	10925896	11/13/2028	DP		03/10/2021
001	10925896*PED	05/13/2029
001	10925897	11/13/2028	DP		03/10/2021
001	10925897*PED	05/13/2029
001	10933090	11/13/2028	DP		03/10/2021
001	10933090*PED	05/13/2029
001	11013761	11/13/2028	DP		06/02/2021
001	11013761*PED	05/13/2029
001	11013762	11/13/2028	DP		06/02/2021
001	11013762*PED	05/13/2029
001	11234938	11/26/2034	DP		02/17/2022
001	11234938*PED	05/26/2035
001	11446252	11/26/2034	DP		09/20/2022
001	11446252*PED	05/26/2035

Product No	Exclusivity Code	Exclusivity Expiration