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
002	9180091	12/20/2033	DP	U-2316 U-2317	06/19/2018
002	9289382	11/21/2032	DP		06/19/2018
002	10258630	12/20/2033		U-2316 U-2317	04/18/2019
002	10398708	12/20/2033		U-2317 U-2614	09/12/2019
002	10471072	06/18/2033		U-2316 U-2317	12/06/2019
002	10537581	11/21/2032	DP	U-2316 U-2317	02/13/2020
002	10568891	06/18/2033		U-2316 U-2317	03/19/2020
002	10668082	06/18/2033		U-2316 U-2317	06/10/2020
002	10806697	11/21/2032	DP		10/22/2020
002	10835487	11/21/2032		U-2316 U-2317	11/18/2020
002	10888516	06/18/2033		U-2316 U-2317	02/08/2021
002	11065197	06/18/2033	DP		08/05/2021
002	11116717	06/18/2033	DP		09/24/2021
002	11123283	06/18/2033	DP		09/24/2021
002	11241445	11/21/2032		U-2316 U-2317	02/18/2022
002	11246875	11/21/2032		U-2316 U-2317	02/18/2022
002	11266661	02/02/2034		U-2316 U-2317	03/11/2022
002	11304959	11/21/2032	DP		04/20/2022
002	11351182	11/21/2032		U-2316 U-2317	06/09/2022
002	11497709	11/21/2032		U-2316 U-2317	11/21/2022

Product No	Exclusivity Code	Exclusivity Expiration