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LAZCLUZE

NDA

LAZERTINIB MESYLATE | N219008 | JANSSEN BIOTECH INC

2 strengths8 unique patents1 unique exclusivity

Patent Timeline

8 unique patents, 1 exclusivity by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Oct. 13, 2035

Apr. 18, 2038

Aug. 1, 2041

May. 21, 2040

Apr. 18, 2038

Apr. 13, 2041

Apr. 18, 2038

May. 14, 2040

NCE

Aug. 19, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 4, 2026	SUPPL -4	View Letter (PDF)
Nov 10, 2025	SUPPL -3	View Letter (PDF)
Aug 18, 2025	SUPPL -2	View Letter (PDF)
Aug 20, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 80MG BASE

RLD

8 patents1 exclusivity▴

TABLET;ORAL | Approved: Aug 19, 2024

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9593098	Oct 13, 2035	—	Yes	Yes		—
11453656	Apr 18, 2038	—	Yes	Yes	—	—
11850248	Aug 1, 2041	—	—	—		—
11879013	May 21, 2040	—	—	—		—
11981659	Apr 18, 2038	—	—	—		—
12138351	Apr 13, 2041	—	—	Yes	—	—
12318390	Apr 18, 2038	—	—	Yes	—	—
12599606	May 14, 2040	—	—	—	U-4512	—

Exclusivities (1)

Code	Date	Status
NCE	Aug 19, 2029	Active

#002 — EQ 240MG BASE

RLD

8 patents1 exclusivity▾

TABLET;ORAL | Approved: Aug 19, 2024

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Janssen Biotech added U.S. Patent 12,599,606 to the Orange Book for Lazcluze (lazertinib mesylate), NDA 219008.

New: New record

ADDED7/1/2026

Janssen Biotech added U.S. Patent 12,599,606 to the Orange Book for Lazcluze (lazertinib mesylate), NDA 219008.

New: New record