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
002	7232818	04/14/2025	DS	DP		08/15/2016
002	7417042	07/20/2026	DS	DP		08/15/2016
002	7491704	04/14/2025			U-1260 U-2319 U-2320 U-2947	08/15/2016
002	7737112	12/07/2027		DP		08/15/2016
002	8129346	04/14/2025			U-1260 U-2319 U-2320 U-2947	08/15/2016
002	8207125	04/14/2025	DS	DP		08/15/2016
002	8207126	04/14/2025		DP		08/15/2016
002	8207127	04/14/2025			U-1260 U-2319 U-2320 U-2947	08/15/2016
002	8207297	04/14/2025	DS	DP		08/15/2016
002	9493582	02/27/2033		DP		03/09/2017
002	RE47954	10/21/2029			U-3449	10/18/2022

Product No	Exclusivity Code	Exclusivity Expiration