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FRUZAQLA Drug Patent Profile

When do Fruzaqla patents expire, and when can generic versions of Fruzaqla launch?

Fruzaqla is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-eight patent family members in thirty-two countries.

The generic ingredient in FRUZAQLA is fruquintinib. One supplier is listed for this compound. Additional details are available on the fruquintinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Fruzaqla

Fruzaqla will be eligible for patent challenges on November 30, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FRUZAQLA

International Patents:	68
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for FRUZAQLA
What excipients (inactive ingredients) are in FRUZAQLA?	FRUZAQLA excipients list
DailyMed Link:	FRUZAQLA at DailyMed

See drug prices for FRUZAQLA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FRUZAQLA

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217564

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for FRUZAQLA

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FRUZAQLA

FRUZAQLA is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FRUZAQLA

FDA Regulatory Exclusivity protecting FRUZAQLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No			Y	Y

International Patents for FRUZAQLA

When does loss-of-exclusivity occur for FRUZAQLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FRUZAQLA around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0908675	"composto, composição farmacêutica, método de tratamento de um distúrbio relacionado à angiogênese e método de inibição da atividade do receptor do fator de crescimento epidérmico"
Mexico	2010012168	DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Japan	2011519956