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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientOLUTASIDENIB
Application typeNDA
Application215814
Product001
Dosage formCAPSULE
RouteORAL
Strength150MG
Approval date2022-12-01
Marketing statusPrescription
Status event—
ApplicantRIGEL PHARMS
Product source

Current GenericRadar decision

Year2039
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2039-07-17
Patent anchor2039-07-17
Exclusivity anchor2029-12-01
Protection date2039-11-12
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2039. Anchor type: PATENT. Patent anchor: 2039-07-17. Exclusivity anchor: 2029-12-01. Anchor date: 2039-07-17. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
104147522035-09-18DP —NNDP
English description not available.
———
104147522035-09-18ORANGE_BOOK —NNDP
English description not available.
———
105500982035-09-18DP —NNPROCESS
English description not available.
———
105500982035-09-18ORANGE_BOOK —NNPROCESS
English description not available.
———
114989132035-09-18DP —NNDP
English description not available.
———
114989132035-09-18ORANGE_BOOK —NNDP
English description not available.
———
122757152035-09-18DS/DP/U U-3684YNTRUE_DS
English description not available.
———
122757152035-09-18ORANGE_BOOK U-3684YNTRUE_DS
English description not available.
———
98345392035-09-18DS/DP/U U-3497YNTRUE_DS
English description not available.
———
98345392035-09-18ORANGE_BOOK U-3497YNTRUE_DS
English description not available.
———
105320472039-05-16DS —NNDP
English description not available.
———
105320472039-05-16ORANGE_BOOK —NNDP
English description not available.
———
109599942039-05-16DP —NNDP
English description not available.
———
109599942039-05-16ORANGE_BOOK —NNDP
English description not available.
———
110137332039-05-16U U-3496NNU
English description not available.
———
110137332039-05-16ORANGE_BOOK U-3496NNU
English description not available.
———
110137342039-05-16U U-3495NNU
English description not available.
———
110137342039-05-16ORANGE_BOOK U-3495NNU
English description not available.
———
113762462039-05-16U U-3495NYU
English description not available.
———
113762462039-05-16ORANGE_BOOK U-3495NYU
English description not available.
———
114977432039-05-16U U-3495NNU
English description not available.
———
114977432039-05-16ORANGE_BOOK U-3495NNU
English description not available.
———
120534632039-05-16DS/DP —NNDP
English description not available.
———
120534632039-05-16ORANGE_BOOK —NNDP
English description not available.
———
117380182039-07-17U U-3684NYU
English description not available.
———
117380182039-07-17ORANGE_BOOK U-3684NYU
English description not available.
———
117239052039-11-12DP —NNDP
English description not available.
———
117239052039-11-12ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2022-12-012027-12-01English description not available.YY2027-12-01—Source
NCE2022-12-012027-12-01English description not available.YY2027-12-01
ODE-413
Full coverage date: 2027-12-01
Source
ODE-4132022-12-012029-12-01English description not available.YY2029-12-01—Source
ODE-4132022-12-012029-12-01English description not available.YY2029-12-01
ODE-413
Full coverage date: 2029-12-01
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 (17)
TypeDateRoleBasisSource
PATENT2035-09-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-09-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-09-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-09-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-09-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-05-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-07-17CANONICAL_ANCHOREnglish description not available.Source
PATENT2039-11-12FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2039-07-17CANONICAL_DECISIONEnglish description not available.Source
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.