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
003	7342118	08/18/2025	DS			04/12/2024
003	7795447	08/18/2025	DS			04/12/2024
003	7951958	03/11/2025	DS			04/12/2024
003	10590087	08/09/2039	DS			04/12/2024
003	10710966	08/09/2039	DS		U-3754	04/12/2024
003	10941118	08/09/2039	DS		U-3754	04/12/2024
003	11504354	07/08/2042		DP		04/12/2024
003	11612588	07/08/2042		DP	U-3754	04/12/2024
003	11807611	09/08/2042		DP	U-3754	04/12/2024
003	11820748	08/09/2039		DP		04/12/2024
003	11844780	09/08/2042		DP	U-3754	04/12/2024
003	11845732	08/09/2039	DS		U-3754	04/12/2024
003	11872211	05/19/2043			U-3754	04/12/2024
003	11884634	08/09/2039		DP		04/12/2024
003	11884635	08/09/2039		DP		04/12/2024
003	11905255	08/09/2039		DP		04/12/2024
003	11925619	05/19/2043			U-3754	04/12/2024
003	11925620	05/19/2043			U-3754	04/12/2024
003	11938116	05/19/2043			U-3754	04/12/2024
003	11951096	05/19/2043			U-3754	04/24/2024
003	11957662	05/19/2043			U-3754	04/24/2024

Product No	Exclusivity Code	Exclusivity Expiration
003	NCE	11/27/2028
003	ODE*	11/27/2030