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
007	8808741	08/24/2027			U-1556	08/19/2014
007	8894988	08/24/2027		DP		11/25/2014
007	9073933	03/30/2025	DS			08/03/2015
007	9492389	08/24/2027		DP		11/16/2016
007	9492391	08/24/2027			U-1556	11/16/2016
007	9492392	08/24/2027		DP		11/16/2016
007	9492393	08/24/2027			U-1556	11/16/2016
007	9522919	03/30/2025	DS	DP		12/20/2016
007	9763933	08/24/2027		DP		09/19/2017
007	9770416	08/24/2027		DP		09/27/2017
007	9775808	08/24/2027		DP		10/04/2017
007	10407434	03/30/2025	DS			09/10/2019
007	10696684	03/30/2025	DS			06/30/2020
007	11304908	08/24/2027		DP		04/21/2022
007	11304909	08/24/2027			U-1556	04/21/2022
007	11964056	08/24/2027		DP		04/25/2024
007	12060361	03/30/2025		DP	U-1556	08/15/2024

Product No	Exclusivity Code	Exclusivity Expiration