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	8591922	01/11/2033	DP		08/19/2020
001	8772306	03/15/2033		U-1532 U-3198	08/19/2020
001	8772306*PED	09/15/2033
001	8901173	01/11/2033	DP		08/19/2020
001	9050302	03/15/2033		U-1532	08/19/2020
001	9050302*PED	09/15/2033
001	9132107	01/11/2033	DP		08/19/2020
001	9486426	03/15/2033		U-1532	08/19/2020
001	9486426*PED	09/15/2033
001	10195168	01/11/2033	DP		08/19/2020
001	10213400	03/15/2033		U-2499	08/19/2020
001	10213400*PED	09/15/2033
001	10675258	01/11/2033		U-2938	08/19/2020
001	10864181	03/15/2033		U-3017	01/13/2021
001	10864181*PED	09/15/2033
001	11253494	03/15/2033		U-3323 U-3324	03/15/2022
001	11253494*PED	09/15/2033
001	11426373	09/19/2037		U-3432	09/27/2022
001	11554102	01/11/2033	DP		02/08/2023