GenericRadar
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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientUMBRALISIB TOSYLATE
Application typeNDA
Application213176
Product001
Dosage formTABLET
RouteORAL
StrengthEQ 200MG BASE
Approval date2021-02-05
Marketing statusWITHDRAWN
Status event—
ApplicantTG THERAPS
Product source

Current GenericRadar decision

Year2022
SelectionDISQUALIFIED
ReviewFINAL
Anchor typeFDA_APPROVAL_WITHDRAWAL
Anchor date2022-05-31
Patent anchor2035-02-05
Exclusivity anchor2026-02-05
Protection date2035-05-26
First Final ANDA—
Status event2022-05-31

FDA_APPROVAL_WITHDRAWN; US:NDA:213176:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100720132033-07-02U U-3063NYU
| B1C03P8 issued-claim review2026-10-15: U
———
100720132033-07-02U U-3064NYU
| B1C03P8 issued-claim review2026-10-15: U
———
100720132033-07-02ORANGE_BOOK U-3063;U-3064NYU
English description not available.
———
105701422033-07-02DS/DP/U U-3063NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
105701422033-07-02DS/DP/U U-3064NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
105701422033-07-02ORANGE_BOOK U-3063;U-3064NNDP
English description not available.
———
109819192033-07-02U U-3064YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
109819192033-07-02U U-3063YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
109819192033-07-02ORANGE_BOOK U-3063;U-3064YNTRUE_DS
English description not available.
———
96690332033-07-02U U-3063NYU
| B1C03P8 issued-claim review2026-10-15: U
———
96690332033-07-02U U-3064NYU
| B1C03P8 issued-claim review2026-10-15: U
———
96690332033-07-02ORANGE_BOOK U-3063;U-3064NYU
English description not available.
———
91505792035-02-05DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
91505792035-02-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
104147732035-05-26DS/DP/U U-3064NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
104147732035-05-26DS/DP/U U-3063NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
104147732035-05-26ORANGE_BOOK U-3063;U-3064NNDP
English description not available.
———
109472442035-05-26U U-3064NNU
| B1C03P8 issued-claim review2026-10-15: U
———
109472442035-05-26U U-3063NNU
| B1C03P8 issued-claim review2026-10-15: U
———
109472442035-05-26ORANGE_BOOK U-3063;U-3064NNU
English description not available.
———
99697402035-05-26DS/DP/U U-3064NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
99697402035-05-26DS/DP/U U-3063NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
99697402035-05-26ORANGE_BOOK U-3063;U-3064NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
ODE-3432021-02-052022-05-31English description not available.NN—
NCE
Full coverage date: —
Source
ODE-3442021-02-052022-05-31English description not available.NN—
NCE
Full coverage date: —
Source
NCE2021-02-052026-02-05English description not available.YY2026-02-05—Source
NCE2021-02-052026-02-05English description not available.YY2026-02-05
NCE
Full coverage date: 2026-02-05
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 (12)
TypeDateRoleBasisSource
PATENT2033-07-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-07-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-07-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-07-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-02-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-05-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-05-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-05-26HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2022-05-31TERMINAL_STATUSFDA_APPROVAL_WITHDRAWN; US:NDA:213176:001; 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.