GenericRadar
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Product profile · United States

LAZCLUZE

 ·  Patent Litigation & Settlement History ↓

IngredientLAZERTINIB MESYLATE
Application typeNDA
Application219008
Product002
Dosage formTABLET
RouteORAL
StrengthEQ 240MG BASE
Approval date2024-08-19
Marketing statusPrescription
Status event—
ApplicantJANSSEN BIOTECH
Product source

Current GenericRadar decision

Year2041
SelectionCANDIDATE
ReviewFINAL
Anchor typePATENT
Anchor date2041-08-01
Patent anchor2041-08-01
Exclusivity anchor2029-08-19
Protection date2041-08-01
First Final ANDA—
Status event—

NO_POST_ANCHOR_RIGHTS; US:NDA:219008:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
95930982035-10-13DS/DP/U U-3985NNTRUE_DS
English description not available.
———
95930982035-10-13ORANGE_BOOK U-3985NNTRUE_DS
English description not available.
———
RE505282035-10-13DS/DP/U U-3985YNTRUE_DS
English description not available.
———
RE505282035-10-13ORANGE_BOOK U-3985YNTRUE_DS
English description not available.
———
114536562038-04-18DS/DP —NNDP
English description not available.
———
114536562038-04-18ORANGE_BOOK —NNDP
English description not available.
———
119816592038-04-18U U-3985NNU
English description not available.
———
119816592038-04-18ORANGE_BOOK U-3985NNU
English description not available.
———
123183902038-04-18DP —NNDP
English description not available.
———
123183902038-04-18ORANGE_BOOK —NNDP
English description not available.
———
125996062040-05-14U U-4511NYU
English description not available.
———
125996062040-05-14ORANGE_BOOK U-4511NYU
English description not available.
———
118790132040-05-21U U-3985NYU
English description not available.
———
118790132040-05-21ORANGE_BOOK U-3985NYU
English description not available.
———
121383512041-04-13DP —NNDP
English description not available.
———
121383512041-04-13ORANGE_BOOK —NNDP
English description not available.
———
118502482041-08-01U U-3985NYU
English description not available.
———
118502482041-08-01ORANGE_BOOK U-3985NYU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2024-08-192029-08-19English description not available.YY2029-08-19—Source
NCE2024-08-192029-08-19English description not available.YY2029-08-19
NCE
Full coverage date: 2029-08-19
Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / productApplicantEvent / status Certification event date Product mappingSourceLast verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Decision evidence (11)
TypeDateRoleBasisSource
PATENT2035-10-13NOT_APPLICABLE_TO_EXACT_PRODUCTEnglish description not available.Source
PATENT2035-10-13HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-04-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-04-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-04-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2040-05-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2040-05-21HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-04-13HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-08-01CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2041-08-01CANONICAL_DECISIONNO_POST_ANCHOR_RIGHTS; US:NDA:219008:002; exact Final ANDA not verified; not proof of generic absenceSource
Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.