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
004	10272062	07/21/2037	DP		05/23/2023
004	10736866	07/21/2037	DP		05/23/2023
004	10925844	02/28/2040	DP		05/23/2023
004	10952986	07/21/2037		U-3601	05/23/2023
004	10973795	07/21/2037	DP		05/23/2023
004	11000498	07/21/2037	DP	U-3580	05/23/2023
004	11052061	07/21/2037	DP		05/23/2023
004	11065224	07/21/2037	DP		05/23/2023
004	11400065	07/21/2037		U-3579	05/23/2023
004	11504347	07/21/2037	DP		05/23/2023
004	11583510	02/07/2042		U-3578	05/23/2023
004	11602512	07/21/2037		U-3577	05/23/2023
004	11602513	07/21/2037		U-3576	05/23/2023
004	11766418	07/21/2037	DP		09/29/2023
004	11779557	03/16/2042		U-3705	10/24/2023
004	11839597	07/21/2037	DP		01/04/2024
004	11896572	07/21/2037	DP		02/20/2024

Product No	Exclusivity Code	Exclusivity Expiration
004	NP	05/01/2026
004	ODE-431	05/01/2030