GenericRadar
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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientPRALSETINIB
Application typeNDA
Application213721
Product001
Dosage formCAPSULE
RouteORAL
Strength100MG
Approval date2020-09-04
Marketing statusPrescription
Status event—
ApplicantRIGEL PHARMS
Product source

Current GenericRadar decision

Year2036
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2036-11-01
Patent anchor2036-11-01
Exclusivity anchor2027-12-01
Protection date2043-04-19
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:213721:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100300052036-11-01DS/DP/U U-2952YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
100300052036-11-01DS/DP/U U-3002YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
100300052036-11-01ORANGE_BOOK U-2952;U-3002YNTRUE_DS
English description not available.
———
126551282036-11-01DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
126551282036-11-01ORANGE_BOOK —YNTRUE_DS
English description not available.
———
112731602039-04-03U U-2952NNU
| B1C03P8 issued-claim review2026-10-15: U
———
112731602039-04-03ORANGE_BOOK U-2952NNU
English description not available.
———
118721922039-04-03U U-2952NNU
| B1C03P8 issued-claim review2026-10-15: U
———
118721922039-04-03ORANGE_BOOK U-2952NNU
English description not available.
———
119639582039-04-03U U-2828NNU
| B1C03P8 issued-claim review2026-10-15: U
———
119639582039-04-03ORANGE_BOOK U-2828NNU
English description not available.
———
125393032039-04-03U U-2828NNU
| B1C03P8 issued-claim review2026-10-15: U
———
125393032039-04-03ORANGE_BOOK U-2828NNU
English description not available.
———
124483662042-07-07DS —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
124483662042-07-07ORANGE_BOOK —NNDP
English description not available.
———
126922512043-04-19DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
126922512043-04-19ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2020-09-042025-09-04English description not available.YY2025-09-04
ODE-318 + ODE-341
Full coverage date: 2025-09-04
Source
ODE-3182020-09-042027-09-04English description not available.NN——Source
ODE-3182020-09-042027-09-04English description not available.NN—
ODE-318 + ODE-341
Full coverage date: —
Source
ODE-3402020-12-012027-12-01English description not available.NN——Source
ODE-3402020-12-012027-12-01English description not available.NN—
ODE-318 + ODE-341
Full coverage date: —
Source
ODE-3412020-12-012027-12-01English description not available.NN——Source
ODE-3412020-12-012027-12-01English description not available.NN—
ODE-318 + ODE-341
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 (13)
TypeDateRoleBasisSource
PATENT2036-11-01CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-11-01CANONICAL_ANCHOREnglish description not available.Source
PATENT2039-04-03FTO_TAILEnglish description not available.Source
PATENT2039-04-03FTO_TAILEnglish description not available.Source
PATENT2039-04-03FTO_TAILEnglish description not available.Source
PATENT2039-04-03FTO_TAILEnglish description not available.Source
PATENT2042-07-07FTO_TAILEnglish description not available.Source
PATENT2043-04-19FTO_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—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2036-11-01CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:213721:001; 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.