LAZCLUZE Drug Patent Profile

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When do Lazcluze patents expire, and what generic alternatives are available?

Lazcluze is a drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this drug.

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

DrugPatentWatch^® Generic Entry Outlook for Lazcluze

Lazcluze will be eligible for patent challenges on August 19, 2028. 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 April 18, 2038. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for LAZCLUZE

US Patents:	8
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAZCLUZE

US Patents and Regulatory Information for LAZCLUZE

LAZCLUZE is protected by nine US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LAZCLUZE is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for LAZCLUZE

When does loss-of-exclusivity occur for LAZCLUZE?

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

Argentina

Patent: 1469
Estimated Expiration: ⤷ Start Trial

Australia

Patent: 18256227
Estimated Expiration: ⤷ Start Trial

Patent: 22203486
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2019021868
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 59543
Estimated Expiration: ⤷ Start Trial

China

Patent: 0869367
Estimated Expiration: ⤷ Start Trial

Colombia

Patent: 19011578
Estimated Expiration: ⤷ Start Trial

Eurasian Patent Organization

Patent: 1992501
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 12529
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 0018
Estimated Expiration: ⤷ Start Trial

Patent: 4666
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 26514
Estimated Expiration: ⤷ Start Trial

Patent: 90444
Estimated Expiration: ⤷ Start Trial

Patent: 20517611
Estimated Expiration: ⤷ Start Trial

Patent: 22166179
Estimated Expiration: ⤷ Start Trial

Malaysia

Patent: 1919
Patent: SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 2634
Patent: SAL DE UN COMPUESTO DERIVADO DE AMINOPIRIDINA, UNA FORMA CRISTALINA DE ESTA Y UN PROCESO PARA PREPARARLO (SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME)
Estimated Expiration: ⤷ Start Trial

Patent: 22006357
Patent: SAL DE UN COMPUESTO DERIVADO DE AMINOPIRIDINA, UNA FORMA CRISTALINA DE ESTA, Y UN PROCESO PARA PREPARARLO. (SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME.)
Estimated Expiration: ⤷ Start Trial

Morocco

Patent: 696
Patent: SEL D'UN COMPOSÉ DÉRIVÉ D'AMINOPYRIDINE, FORME CRISTALLINE DE CELUI-CI, ET SON PROCÉDÉ DE PRÉPARATION
Estimated Expiration: ⤷ Start Trial

New Zealand

Patent: 8443
Patent: Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Estimated Expiration: ⤷ Start Trial

Philippines

Patent: 019502370
Patent: SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME
Estimated Expiration: ⤷ Start Trial

Saudi Arabia

Patent: 9410342
Patent: ملح مستخلص من مركب مشتق من الأمينو بيريدين والشكل البلوري منه وعملية تحضيرهما (SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME)
Estimated Expiration: ⤷ Start Trial

Singapore

Patent: 201909615Y
Patent: SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME
Estimated Expiration: ⤷ Start Trial

South Africa

Patent: 1907687
Patent: SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 2629654
Estimated Expiration: ⤷ Start Trial

Patent: 2835717
Estimated Expiration: ⤷ Start Trial

Patent: 180118535
Estimated Expiration: ⤷ Start Trial

Patent: 230175161
Patent: 아미노피리미딘 유도체 화합물의 염, 이의 결정형 및 이의 제조 방법 (A SALT OF AMINOPYRIDINE DERIVATIVE COMPOUND ITS CRYSTALLINE FORM AND A MANUFACTURING PROCESS THEREOF)
Estimated Expiration: ⤷ Start Trial

Patent: 250111074
Patent: 아미노피리미딘 유도체 화합물의 염, 이의 결정형 및 이의 제조 방법 (A SALT OF AMINOPYRIDINE DERIVATIVE COMPOUND ITS CRYSTALLINE FORM AND A MANUFACTURING PROCESS THEREOF)
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 1841910
Patent: Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Estimated Expiration: ⤷ Start Trial

Patent: 76882
Estimated Expiration: ⤷ Start Trial

Ukraine

Patent: 4364
Patent: СІЛЬ ПОХІДНОГО АМІНОПІРИДИНУ, ЇЇ КРИСТАЛІЧНА ФОРМА ТА СПОСІБ ЇЇ ПРИГОТУВАННЯ (SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME)
Estimated Expiration: ⤷ Start Trial

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 LAZCLUZE around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	111469		⤷ Start Trial
Australia	2018256227		⤷ Start Trial
Australia	2022203486		⤷ Start Trial
Brazil	112019021868		⤷ Start Trial
Canada	3059543		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Questions you can ask:

Summary for LAZCLUZE

When does loss-of-exclusivity occur for LAZCLUZE?

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