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
002	6515117	10/04/2025	DS	DP	U-493 U-2139		02/05/2014
002	7456254	06/30/2025			U-2139		11/15/2017
002	7851502	08/19/2028		DP			02/05/2014
002	7919598	12/16/2029	DS				02/05/2014
002	8221786	03/21/2028		DP			02/05/2014
002	8329648	08/18/2026			U-2139 U-2212 U-2213		11/15/2017
002	8361972	03/21/2028			U-493 U-2139		02/05/2014
002	8431685	04/13/2025			U-2139		11/15/2017
002	8461105	04/13/2025			U-2139		11/15/2017
002	8501698	06/20/2027		DP	U-493		02/05/2014
002	8685934	05/26/2030			U-1522		06/25/2014
002	8716251	03/21/2028		DP			06/02/2014
002	8721615	01/18/2030		DP		Y	11/15/2017
002	8906851	08/18/2026			U-2139		11/15/2017
002	9238076	04/15/2024			U-2139		11/15/2017
002	10973836	03/09/2040			U-3127		04/21/2021
002	11826376	07/18/2039			U-3766		12/19/2023
002	11903955	03/09/2040			U-3825		03/13/2024

Product No	Exclusivity Code	Exclusivity Expiration
002	I-857	04/30/2024
002	M-298	05/08/2026