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 Substance	Drug Product	Patent Use Code	Submission Date
001	8008264	09/06/2029	DS	DP		11/12/2020
001	8008264*PED	03/06/2030
001	8318682	04/22/2029	DS	DP		11/12/2020
001	8318682*PED	10/22/2029
001	9724360	10/29/2035	DS	DP		11/12/2020
001	9724360*PED	04/29/2036
001	9949994	10/29/2035	DS			11/12/2020
001	9949994*PED	04/29/2036
001	10065958	09/16/2031	DS			11/12/2020
001	10065958*PED	03/16/2032
001	10675296	07/10/2038		DP		11/12/2020
001	10675296*PED	01/10/2039
001	10695361	09/16/2036			U-3831 U-3832	11/12/2020
001	10695361*PED	03/16/2037
001	11007208	09/16/2036			U-3831 U-3832	06/15/2021
001	11007208*PED	03/16/2037
001	11266681	07/10/2038			U-3831 U-3832	04/04/2022
001	11266681*PED	01/10/2039
001	11382926	09/16/2036			U-3831 U-3832	08/02/2022
001	11382926*PED	03/16/2037
001	11491169	05/28/2041			U-3835 U-3836	12/06/2022
001	11491169*PED	11/28/2041
001	11492353	12/08/2031	DS			12/06/2022
001	11492353*PED	06/08/2032
001	11903953	05/28/2041			U-3835 U-3836	03/19/2024
001	11903953*PED	11/28/2041
001	RE46762	04/22/2029	DS	DP		11/12/2020
001	RE46762*PED	10/22/2029