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LAZCLUZE (LAZERTINIB MESYLATE) | LOERadar
Viewing data from:
Latest
2026-07-01
2026-06-01
2026-05-01
2026-04-01
2026-03-28
2026-02-17
2026-02-10
2025-12-14
2025-02-26
2025-01-25
2024-11-08
2023-07-23
2023-06-15
2023-05-13
2023-01-26
2022-11-22
2022-10-28
2022-09-29
2022-07-09
2022-06-29
2022-04-08
2022-03-09
2021-12-28
2021-05-05
2021-03-12
2020-12-22
2020-11-12
2019-12-14
2019-09-15
LAZCLUZE
NDA
LAZERTINIB MESYLATE | N219008 | JANSSEN BIOTECH INC
2 strengths
8 unique patents
1 unique exclusivity
Patents
SEC Intel
Revenue
PTAB
Reexams
Litigation
Petitions
Trials
Price Trends
VA FSS
Medicare D
Approvals
Label
Products
Patent Timeline
8 unique patents, 1 exclusivity by expiration date
All strengths
EQ 80MG BASE
EQ 240MG BASE
Active (8)
Today
Exclusivity
2026
2027
2028
2029
2030
2031
2032
2033
2034
2035
2036
2037
2038
2039
2040
2041
2042
Today
9593098
Oct. 13, 2035
11453656
Apr. 18, 2038
11850248
Aug. 1, 2041
11879013
May. 21, 2040
11981659
Apr. 18, 2038
12138351
Apr. 13, 2041
12318390
Apr. 18, 2038
12599606
May. 14, 2040
NCE
Aug. 19, 2029
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (2)
Sort:
Name
↑
Applicant
Strength
Approval
#001 — EQ 80MG BASE
RLD
8 patents
1 exclusivity
▴
TABLET;ORAL | Approved: Aug 19, 2024
Patents (8)
· 5 use codes
Patent #
Expiration
PED
Drug Substance
Drug Product
Use Code
Delist
9593098
Oct 13, 2035
—
Yes
Yes
U-3985
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
—
11453656
Apr 18, 2038
—
Yes
Yes
—
—
11850248
Aug 1, 2041
—
—
—
U-3985
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
—
11879013
May 21, 2040
—
—
—
U-3985
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
—
11981659
Apr 18, 2038
—
—
—
U-3985
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
—
12138351
Apr 13, 2041
—
—
Yes
—
—
12318390
Apr 18, 2038
—
—
Yes
—
—
12599606
May 14, 2040
—
—
—
U-4512
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, BY ADMINISTRATION OF EQ 80 MG BASE LAZERTINIB IN COMBINATION WITH AMIVANTAMAB
—
Exclusivities (1)
Code
Date
Status
NCE
Aug 19, 2029
Active
#002 — EQ 240MG BASE
RLD
8 patents
1 exclusivity
▾
TABLET;ORAL | Approved: Aug 19, 2024