GenericRadar
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Product profile · United States

JAYPIRCA

 ·  Patent Litigation & Settlement History ↓

IngredientPIRTOBRUTINIB
Application typeNDA
Application216059
Product002
Dosage formTABLET
RouteORAL
Strength100MG
Approval date2023-01-27
Marketing statusPrescription
Status event—
ApplicantLOXO ONCOL
Product source

Current GenericRadar decision

Year2036
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2036-12-16
Patent anchor2036-12-16
Exclusivity anchor2028-01-27
Protection date2041-09-14
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:216059:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103427802036-12-16DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
103427802036-12-16ORANGE_BOOK —YNTRUE_DS
English description not available.
———
104649052036-12-16U U-3518NYU
| B1C03P7 issued-claim review2026-10-15: U
———
104649052036-12-16U U-4362NYU
| B1C03P7 issued-claim review2026-10-15: U
———
104649052036-12-16ORANGE_BOOK U-3518;U-4362NYU
English description not available.
———
106953232036-12-16DS/DP/U U-3518YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
106953232036-12-16DS/DP/U U-4362YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
106953232036-12-16ORANGE_BOOK U-3518;U-4362YNTRUE_DS
English description not available.
———
109186222036-12-16U U-3518NYU
| B1C03P7 issued-claim review2026-10-15: U
———
109186222036-12-16U U-4362NYU
| B1C03P7 issued-claim review2026-10-15: U
———
109186222036-12-16ORANGE_BOOK U-3518;U-4362NYU
English description not available.
———
122204012036-12-16DS/DP/U U-3518YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
122204012036-12-16DS/DP/U U-4362YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
122204012036-12-16ORANGE_BOOK U-3518;U-4362YNTRUE_DS
English description not available.
———
122686662039-07-29DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
122686662039-07-29ORANGE_BOOK —NNDP
English description not available.
———
121091932041-09-14DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
121091932041-09-14ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2023-01-272028-01-27English description not available.YY2028-01-27—Source
NCE2023-01-272028-01-27English description not available.YY2028-01-27
NCE
Full coverage date: 2028-01-27
Source
I-9812025-12-022028-12-02English description not available.NN——Source
I-9812025-12-022028-12-02English description not available.NN—
NCE
Full coverage date: —
Source
ODE-4242023-01-272030-01-27English description not available.NN——Source
ODE-4242023-01-272030-01-27English description not available.NN—
NCE
Full coverage date: —
Source
ODE-4512023-12-012030-12-01English description not available.NN——Source
ODE-4512023-12-012030-12-01English description not available.NN—
NCE
Full coverage date: —
Source
ODE-5182025-12-032032-12-03English description not available.NN——Source
ODE-5182025-12-032032-12-03English description not available.NN—
NCE
Full coverage date: —
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 (14)
TypeDateRoleBasisSource
PATENT2036-12-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-12-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-12-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-12-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-12-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2039-07-29FTO_TAILEnglish description not available.Source
PATENT2041-09-14FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS—REGULATORY_SCOPE_CONTEXTFDA OOPD exclusivity end date TBD; no invented term; excluded from granted-right anchorSource
REGULATORY_STATUS2036-12-16CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:216059:002; 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.