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	8999996	07/03/2033	DS	DP		07/31/2019
001	9079865	07/26/2032			U-2584 U-2855 U-3018	07/31/2019
001	9714226	07/26/2032	DS	DP		07/31/2019
001	10519139	08/14/2035	DS	DP	U-2584 U-2855 U-3018	01/27/2020
001	10544108	07/26/2032			U-2584 U-3018	02/24/2020
001	11034660	07/26/2032			U-2584 U-3018	07/14/2021
001	11746102	08/14/2035			U-2584 U-2855 U-3018	10/04/2023
001	11753401	08/14/2035		DP	U-2584 U-2855 U-3018	10/11/2023
001	11787771	07/26/2032			U-2584 U-2855 U-3018	11/15/2023
001	11807629	08/14/2035	DS	DP		12/06/2023