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
001	7812049	05/02/2028		U-1959	02/09/2017
001	8420688	08/02/2024		U-1959	02/09/2017
001	8815929	01/22/2024		U-1959	07/12/2018
001	8883838	12/01/2031	DP		02/09/2017
001	9974773	06/11/2035		U-2306	05/22/2018
001	10335391	06/11/2035		U-2567	07/08/2019
001	10751325	06/11/2035		U-2921	08/26/2020
001	11517560	06/11/2035		U-3494	12/29/2022

Product No	Exclusivity Code	Exclusivity Expiration