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: N207981

Product 002
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE (LONSURF) TABLET EQ 8.19MG BASE;20MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	9527833	06/17/2034	DS	DP			01/27/2017
002	9943537	09/05/2034			U-3659		08/07/2023
002	10456399	02/03/2037			U-3657 U-3658		11/08/2019
002	10457666	06/17/2034	DS	DP			11/08/2019
002	10960004	02/03/2037			U-3657 U-3658		04/09/2021
002	RE46284	09/22/2029			U-1751 U-2503 U-3656		02/07/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	ODE-229	02/22/2026

 

 

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