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: N203341

Product 002
BOSUTINIB MONOHYDRATE (BOSULIF) TABLET EQ 500MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7417148	12/11/2025			U-1283 U-3707 U-3708
002	7417148*PED	06/11/2026
002	7767678	11/23/2026	DS	DP
002	7767678*PED	05/23/2027
002	7919625	12/11/2025		DP
002	7919625*PED	06/11/2026
002	11103497	02/28/2034			U-3216 U-3217		09/29/2021
002	11103497*PED	08/28/2034
002	RE42376	04/13/2024	DS
002	RE42376*PED	10/13/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	ODE-163	12/19/2024
002	ODE-163 *PED	06/19/2025
002	I-923	09/26/2026
002	I-923 *PED	03/26/2027
002	ODE-444	09/26/2030
002	ODE-444 *PED	03/26/2031

 

 

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