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
005	8414922	12/16/2031	DP	U-2825	06/04/2020
005	8603514	04/03/2024	DP		06/04/2020
005	8765167	02/20/2024	DP		06/04/2020
005	8846074	12/16/2031	DP	U-2825	06/04/2020
005	9044475	06/11/2030	DP		06/04/2020
005	9283219	06/11/2030	DP	U-2825	06/04/2020
005	9326981	06/11/2030		U-2825	06/04/2020
005	9669019	06/11/2030	DP	U-2825	06/04/2020
005	9669021	06/11/2030		U-2825	06/04/2020
005	10420763	06/11/2030	DP	U-2825	06/04/2020
005	10449146	04/19/2036		U-2825	06/04/2020
005	10821074	08/07/2029	DP		11/12/2020
005	10959943	04/19/2036		U-2825	04/02/2021
005	11419769	12/16/2031	DP	U-2825	09/06/2022

Product No	Exclusivity Code	Exclusivity Expiration