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
003	7144884	06/17/2026	DS	DP	U-1439	10/16/2013
003	7144884*PED	12/17/2026
003	8722684	06/30/2031	DS	DP		06/09/2014
003	8722684*PED	12/30/2031
003	8969355	06/15/2027			U-1668	03/19/2015
003	8969355*PED	12/15/2027
003	9125908	06/15/2027			U-2309	05/24/2018
003	9125908*PED	12/15/2027
003	9125909	06/15/2027			U-2309	05/24/2018
003	9125909*PED	12/15/2027
003	9125910	06/15/2027			U-2309	05/24/2018
003	9125910*PED	12/15/2027
003	9227946	06/15/2027			U-1668	01/21/2016
003	9227946*PED	12/15/2027
003	9278096	03/21/2032			U-2436	11/13/2018
003	9278096*PED	09/21/2032
003	9861630	06/15/2027			U-1668	01/18/2018
003	9861630*PED	12/15/2027
003	11458134	06/15/2027		DP	U-3463	11/02/2022
003	11458134*PED	12/15/2027