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	7994185	01/20/2030	DS	DP	U-1406 U-2031 U-2032 U-2296	06/13/2013
002	7994185*PED	07/20/2030
002	8415345	01/20/2030	DS	DP	U-1406 U-2031 U-2032 U-2296	06/13/2013
002	8415345*PED	07/20/2030
002	8703781	10/15/2030	DS	DP	U-1713 U-2032 U-2296 U-2298	05/22/2015
002	8703781*PED	04/15/2031
002	8835443	06/10/2025			U-2026 U-2027 U-2296 U-2298	07/18/2017
002	8835443*PED	12/10/2025
002	8952018	10/15/2030			U-2027	07/18/2017
002	8952018*PED	04/15/2031
002	9233956	05/04/2029			U-1811 U-2031 U-2032 U-2296	02/24/2016
002	9233956*PED	11/04/2029
002	10869869	08/30/2033			U-3185	08/18/2021
002	10869869*PED	03/02/2034