GenericRadar
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Published markets; coverage varies by country
Product profile · United States

WAYRILZ

 ·  Patent Litigation & Settlement History ↓

IngredientRILZABRUTINIB
Application typeNDA
Application219685
Product001
Dosage formTABLET
RouteORAL
Strength400MG
Approval date2025-08-29
Marketing statusPrescription
Status event—
ApplicantGENZYME CORP
Product source

Current GenericRadar decision

Year2033
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2033-09-06
Patent anchor2033-09-06
Exclusivity anchor2032-08-29
Protection date2041-02-20
First Final ANDA—
Status event—

ANCHOR_WITH_TAIL; US:NDA:219685:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
95804272033-03-01DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
95804272033-03-01ORANGE_BOOK —YNTRUE_DS
English description not available.
———
89407442033-09-06DS/DP/U U-4270YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
89407442033-09-06ORANGE_BOOK U-4270YNTRUE_DS
English description not available.
———
92668952033-09-06DS/DP/U U-4268YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
92668952033-09-06ORANGE_BOOK U-4268YNTRUE_DS
English description not available.
———
99945762033-09-06DS/DP/U U-4269YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
99945762033-09-06DS/DP/U U-4268YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
99945762033-09-06ORANGE_BOOK U-4268;U-4269YNTRUE_DS
English description not available.
———
121788182040-10-13U U-4267NNU
| B1C03 issued-claim review2026-10-15: U
———
121788182040-10-13ORANGE_BOOK U-4267NNU
English description not available.
———
117083702041-02-20DS —NNDP
| B1C03 issued-claim review2026-10-15: DP
———
117083702041-02-20ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-08-292030-08-29English description not available.YY2030-08-29—Source
NCE2025-08-292030-08-29English description not available.YY2030-08-29
ODE-552
Full coverage date: 2030-08-29
Source
ODE-5522025-08-292032-08-29English description not available.YY2032-08-29—Source
ODE-5522025-08-292032-08-29English description not available.YY2032-08-29
ODE-552
Full coverage date: 2032-08-29
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 (9)
TypeDateRoleBasisSource
PATENT2033-03-01HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-09-06CANONICAL_ANCHOREnglish description not available.Source
PATENT2033-09-06CANONICAL_ANCHOREnglish description not available.Source
PATENT2033-09-06CANONICAL_ANCHOREnglish description not available.Source
PATENT2040-10-13FTO_TAILEnglish description not available.Source
PATENT2041-02-20FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2033-09-06CANONICAL_DECISIONANCHOR_WITH_TAIL; US:NDA:219685:001; 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.