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	Delist Requested	Submission Date
001	7407955	05/02/2025	DS	DP			02/19/2015
001	7407955*PED	11/02/2025
001	7579449	08/01/2028	DS				02/19/2015
001	7579449*PED	02/01/2029
001	7713938	04/15/2027	DS	DP			02/19/2015
001	7713938*PED	10/15/2027
001	8551957	10/14/2029		DP	U-1651		02/19/2015
001	8551957*PED	04/14/2030
001	8673927	05/04/2027			U-1652	Y	02/19/2015
001	8673927*PED	11/04/2027
001	8883805	11/26/2025		DP			02/19/2015
001	8883805*PED	05/26/2026
001	9173859	05/04/2027		DP	U-1772	Y	12/02/2015
001	9949998	06/11/2034			U-2290		05/15/2018
001	10258637	04/03/2034			U-2290		04/30/2019
001	10258637*PED	10/03/2034
001	11033552	05/04/2027		DP			07/09/2021
001	11033552*PED	11/04/2027
001	11090323	04/03/2034			U-3191		08/20/2021
001	11090323*PED	10/03/2034
001	11833166	04/03/2034			U-3776 U-3777		01/03/2024

Product No	Exclusivity Code	Exclusivity Expiration