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
002	8299057	03/01/2029	DS	DP		09/13/2019
002	8673893	07/08/2028			U-2617 U-2618	09/13/2019
002	9029356	07/08/2028	DS	DP		09/13/2019
002	9085558	07/08/2028		DP		09/13/2019
002	9085565	05/22/2033	DS	DP		09/13/2019
002	9255087	07/08/2028			U-2617 U-2618	09/13/2019
002	9616059	07/08/2028			U-2618	09/13/2019
002	9649306	05/22/2033			U-2617 U-2618	09/13/2019
002	10231965	02/17/2035			U-2617 U-2618	09/13/2019
002	10398693	07/18/2038		DP		09/13/2019
002	10561651	02/19/2035			U-2745	03/13/2020
002	10738037	05/18/2037	DS	DP	U-2946	09/09/2020
002	11091469	05/18/2037			U-2617 U-2618	09/10/2021
002	11253515	07/18/2038		DP		03/22/2022