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	8962629	01/15/2031	DS		U-3341 U-3624	02/10/2022
002	9951080	10/17/2036	DS	DP		02/10/2022
002	10344036	10/17/2036		DP		02/10/2022
002	10550126	10/17/2036			U-3298	02/10/2022
002	10730883	10/17/2036		DP		02/10/2022
002	10981923	10/17/2036	DS			02/10/2022
002	10981924	10/17/2036		DP		02/10/2022
002	11186584	10/17/2036	DS			02/10/2022
002	11198697	10/17/2036		DP		02/10/2022
002	11535626	10/17/2036			U-3298	01/26/2023
002	11564922	03/09/2038			U-3624	08/11/2023
002	11607411	03/09/2038			U-3341	08/11/2023
002	11661425	10/17/2036	DS	DP		06/29/2023
002	11680069	10/17/2036	DS	DP		07/20/2023
002	11718627	10/17/2036	DS	DP		08/11/2023
002	11767326	10/17/2036			U-3298	10/23/2023
002	11773105	10/17/2036	DS	DP		11/02/2023
002	RE47221	08/16/2033	DS			02/10/2022