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	7449458	09/04/2031	DS			05/16/2018
001	7538108	03/28/2026	DS		U-2294	05/16/2018
001	7989448	06/12/2026	DS		U-2294	05/16/2018
001	8163902	06/17/2026	DS		U-2294	05/16/2018
001	8211889	01/19/2026	DS			05/16/2018
001	8263122	11/24/2030		DP		05/16/2018
001	8445485	06/17/2026		DP		05/16/2018
001	8652492	11/06/2028		DP		05/16/2018
001	8771648	07/27/2032		DP		05/16/2018
001	8912170	06/17/2026			U-2294	05/16/2018
001	8951504	07/27/2032			U-2294	05/16/2018
001	9266912	01/19/2026			U-2294	05/16/2018
001	9283238	06/17/2026			U-2294	05/16/2018
001	RE48898	01/19/2026		DP		02/23/2022

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-174	04/17/2025