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
007	8808740	12/21/2031	DP	U-1556	11/21/2014
007	9084816	08/24/2027	DP		07/21/2015
007	9095614	08/24/2027		U-1556	08/04/2015
007	9095615	08/24/2027	DP		08/04/2015
007	9486412	08/24/2027	DP		11/08/2016
007	9486413	08/24/2027	DP		11/08/2016
007	9492389	08/24/2027	DP		11/16/2016
007	9492390	08/24/2027		U-1556	11/17/2016
007	9492391	08/24/2027		U-1556	11/17/2016
007	9545380	08/24/2027		U-1556	01/17/2017
007	9572779	12/21/2031	DP		02/21/2017
007	9750703	12/21/2031	DP		09/14/2017
007	9763933	08/24/2027	DP		09/19/2017
007	9770416	08/24/2027	DP		09/27/2017
007	9775809	08/24/2027	DP		10/04/2017
007	9861584	12/21/2031	DP		01/10/2018
007	9872837	12/21/2031	DP		01/23/2018
007	11304908	08/24/2027	DP		04/21/2022
007	11304909	08/24/2027		U-1556	04/21/2022
007	11844865	02/13/2025	DP	U-1556	12/22/2023

Product No	Exclusivity Code	Exclusivity Expiration