LAZCLUZE Drug Patent Profile

✉ Email this page to a colleague

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 five patents protecting this drug.

This drug has one hundred and one patent family members in thirty-four countries.

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 August 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for LAZCLUZE?
What are the global sales for LAZCLUZE?
What is Average Wholesale Price for LAZCLUZE?

Summary for LAZCLUZE

International Patents:	101
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in LAZCLUZE?	LAZCLUZE excipients list
DailyMed Link:	LAZCLUZE at DailyMed

Drug patent expirations by year for LAZCLUZE

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

Generic Entry Date for LAZCLUZE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 219008 Dosage: TABLET;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.

US Patents and Regulatory Information for LAZCLUZE

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

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

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 LAZCLUZE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB

FDA Regulatory Exclusivity protecting LAZCLUZE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

See the table below for patents covering LAZCLUZE around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	106795144		⤷ Sign Up
Lithuania	3604294		⤷ Sign Up
South Africa	201907687	SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME	⤷ Sign Up
European Patent Office	4421069		⤷ Sign Up
South Korea	20220010731	이중특이성 항-EGFR/c-Met 항체와 제3 세대 EGFR 티로신 키나제 억제제에 의한 병용 요법	⤷ Sign Up
Cyprus	1124359		⤷ Sign Up
South Korea	20180118535	아미노피리미딘 유도체 화합물의 염, 이의 결정형 및 이의 제조 방법 (A SALT OF AMINOPYRIDINE DERIVATIVE COMPOUND ITS CRYSTALLINE FORM AND A MANUFACTURING PROCESS THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration