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	7378423	05/29/2027	DS	DP
002	7378423*PED	11/29/2027
002	8580304	01/28/2032		DP
002	8580304*PED	07/28/2032
002	8703781	10/15/2030	DS	DP	U-1712 U-2020 U-2037 U-2302 U-2305	05/22/2015
002	8703781*PED	04/15/2031
002	8835443	06/10/2025			U-1581 U-1582 U-2020 U-2037 U-2302 U-2305	10/07/2014
002	8835443*PED	12/10/2025
002	8952018	10/15/2030			U-2020	09/22/2016
002	8952018*PED	04/15/2031
002	9155706	01/28/2032		DP		09/22/2016
002	9155706*PED	07/28/2032
002	9271941	01/28/2032		DP		09/22/2016
002	9271941*PED	07/28/2032
002	9399021	01/28/2032		DP		12/19/2019
002	9399021*PED	07/28/2032
002	10869869	08/30/2033			U-3184	08/18/2021
002	10869869*PED	03/02/2034