Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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.

Patent and Exclusivity for: N200603

Product 005
LURASIDONE HYDROCHLORIDE (LATUDA) TABLET 60MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
005	8729085	05/26/2026		DP			05/29/2014
005	8729085*PED	11/26/2026
005	8883794	05/26/2026		DP			11/12/2014
005	8883794*PED	11/26/2026
005	9174975	02/20/2024			U-1770		11/23/2015
005	9174975*PED	08/20/2024
005	9259423	05/23/2031			U-1822		03/15/2016
005	9259423*PED	11/23/2031
005	9555027	05/26/2026		DP	U-543		03/01/2017
005	9815827	02/20/2024			U-543 U-2166		12/12/2017
005	9827242	05/23/2031			U-2199 U-2201		12/19/2017
005	9907794	05/26/2026		DP			03/19/2018
005	9907794*PED	11/26/2026
005	RE45573	06/23/2025	DS				06/24/2015
005	RE45573*PED	12/23/2025

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

View a list of all patent use codes
View a list of all exclusivity codes