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
002	8008264	09/06/2029	DS	DP		11/12/2020
002	8008264*PED	03/06/2030
002	8318682	04/22/2029	DS	DP		11/12/2020
002	8318682*PED	10/22/2029
002	9724360	10/29/2035	DS	DP		11/12/2020
002	9724360*PED	04/29/2036
002	9949994	10/29/2035	DS			11/12/2020
002	9949994*PED	04/29/2036
002	10065958	09/16/2031	DS			11/12/2020
002	10065958*PED	03/16/2032
002	10695361	09/16/2036			U-3829 U-3830	11/12/2020
002	10695361*PED	03/16/2037
002	11007208	09/16/2036			U-3829 U-3830	06/15/2021
002	11007208*PED	03/16/2037
002	11382926	09/16/2036			U-3829 U-3830	08/02/2022
002	11382926*PED	03/16/2037
002	11491169	05/28/2041			U-3833 U-3834	12/06/2022
002	11491169*PED	11/28/2041
002	11492353	12/08/2031	DS			12/06/2022
002	11492353*PED	06/08/2032
002	11903953	05/28/2041			U-3837 U-3838	03/19/2024
002	11903953*PED	11/28/2041
002	RE46762	04/22/2029	DS	DP		11/12/2020
002	RE46762*PED	10/22/2029