GenericRadar
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Product profile · United States

TRUQAP

 ·  Patent Litigation & Settlement History ↓

IngredientCAPIVASERTIB
Application typeNDA
Application218197
Product002
Dosage formTABLET
RouteORAL
Strength200MG
Approval date2023-11-16
Marketing statusPrescription
Status event—
ApplicantASTRAZENECA
Product source

Current GenericRadar decision

Year2030
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2030-03-10
Patent anchor2030-03-10
Exclusivity anchor2028-11-16
Protection date2033-04-16
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:218197:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100597142028-10-10DS/DP —YNTRUE_DS
English description not available.
———
100597142028-10-10ORANGE_BOOK —YNTRUE_DS
English description not available.
———
106548552028-10-10U U-3762NNU
English description not available.
———
106548552028-10-10ORANGE_BOOK U-3762NNU
English description not available.
———
112360952028-10-10U U-4559NNU
English description not available.
———
112360952028-10-10ORANGE_BOOK U-4559NNU
English description not available.
———
117607602028-10-10U U-3762NNU
English description not available.
———
117607602028-10-10ORANGE_BOOK U-3762NNU
English description not available.
———
122524952028-10-10U U-3762NNU
English description not available.
———
122524952028-10-10ORANGE_BOOK U-3762NNU
English description not available.
———
94924532028-10-10U U-4559NNU
English description not available.
———
94924532028-10-10ORANGE_BOOK U-4559NNU
English description not available.
———
81016232030-03-10DS/DP/U U-3762YNTRUE_DS
English description not available.
———
81016232030-03-10ORANGE_BOOK U-3762YNTRUE_DS
English description not available.
———
100397662033-04-16U U-3762NNU
English description not available.
———
100397662033-04-16U U-4559NNU
English description not available.
———
100397662033-04-16ORANGE_BOOK U-3762,U-4559NNU
English description not available.
———
94875252033-04-16DS/DP —NNDP
English description not available.
———
94875252033-04-16ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2023-11-162028-11-16English description not available.YY2028-11-16—Source
NCE2023-11-162028-11-16English description not available.YY2028-11-16
NCE
Full coverage date: 2028-11-16
Source
I-9912026-06-122029-06-12English description not available.NN——Source
I-9912026-06-122029-06-12English 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 (12)
TypeDateRoleBasisSource
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-10-10HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-03-10CANONICAL_ANCHOREnglish description not available.Source
PATENT2033-04-16FTO_TAILEnglish description not available.Source
PATENT2033-04-16FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2030-03-10CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:218197:002; 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.