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	9561229	09/18/2035	DP	U-2161	12/05/2017
001	9808465	09/18/2035		U-2161	12/05/2017
001	9974742	09/18/2035	DP		06/19/2018
001	9974793	09/18/2035	DP		06/19/2018
001	9974794	09/18/2035	DP	U-2161	06/19/2018
001	10500208	09/18/2035	DP		12/23/2019
001	10624850	09/18/2035		U-2161	04/30/2020
001	10953018	09/18/2035		U-2161	04/08/2021
001	11173118	09/18/2035	DP		12/13/2021
001	11744800	09/18/2035	DP		10/02/2023

Product No	Exclusivity Code	Exclusivity Expiration