Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N214410

Product 001
BALOXAVIR MARBOXIL (XOFLUZA) FOR SUSPENSION 2MG/ML

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8927710	05/05/2031		DP			12/17/2020
001	8987441	09/21/2031	DS	DP			12/17/2020
001	9815835	06/14/2030		DP			12/17/2020
001	10392406	04/27/2036	DS				12/17/2020
001	10633397	04/27/2036			U-2816 U-3000		12/17/2020
001	10759814	08/09/2037	DS	DP			12/17/2020
001	11261198	09/25/2038		DP			04/04/2022
001	11306106	08/09/2037			U-2816 U-3000		05/17/2022
001	11925648	04/21/2041		DP			03/28/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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