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	7975690	08/18/2025	DP	U-1809	02/23/2016
001	8550073	10/22/2029	DP		02/23/2016
001	8590530	09/15/2025	DP	U-1809	02/23/2016
001	8875704	04/07/2028	DP	U-1809	02/23/2016
001	8899229	08/18/2030	DP		02/23/2016
001	8978647	12/06/2030	DP		02/23/2016
001	9108015	09/15/2025	DP		02/23/2016
001	9119932	04/23/2024	DP		02/23/2016
001	9649456	10/21/2030	DP	U-1719 U-2010 U-2011	05/26/2017
001	10076614	10/20/2034	DP		10/12/2018
001	10076615	07/30/2029		U-2010 U-2011 U-2404	10/12/2018
001	10124132	03/06/2027	DP	U-1719 U-2010 U-2011	12/10/2018
001	10398859	12/19/2027	DP		09/30/2019
001	10478574	11/04/2033		U-2404	12/09/2019
001	10722667	12/30/2028	DP		08/25/2020
001	11571531	02/23/2026		U-1809	05/19/2023

Product No	Exclusivity Code	Exclusivity Expiration