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	7314938	03/10/2025	DS	DP		08/03/2016
001	7745460	11/05/2024	DS	DP	U-1880	08/03/2016
001	7790743	11/05/2024			U-1880	08/03/2016
001	7928122	11/05/2024	DS	DP		08/03/2016
001	8084047	05/17/2026	DS	DP		08/03/2016
001	8168655	05/09/2029			U-1880	08/03/2016
001	8367701	04/15/2029		DP	U-1880	08/03/2016
001	8592450	05/17/2026			U-1880	08/03/2016
001	8927574	11/12/2030		DP		08/03/2016
001	9085553	07/25/2033		DP		08/03/2016
001	9216174	11/05/2024		DP		08/03/2016
001	9353088	10/21/2030		DP		08/03/2016
001	9447077	04/15/2029			U-1900	10/06/2016
001	9890141	10/21/2030	DS			03/05/2018
001	10124000	11/05/2024			U-1900	12/06/2018
001	11058677	12/18/2033		DP		07/23/2021

Product No	Exclusivity Code	Exclusivity Expiration