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 ·  Patent Litigation & Settlement History ↓

IngredientCABOZANTINIB S-MALATE
Application typeNDA
Application203756
Product001
Dosage formCAPSULE
RouteORAL
StrengthEQ 20MG BASE
Approval date2012-11-29
Marketing statusPrescription
Status event—
ApplicantEXELIXIS
Product source

Current GenericRadar decision

Year2026
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2026-08-14
Patent anchor2026-08-14
Exclusivity anchor2019-11-29
Protection date—
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
75794732026-08-14DS/DP ————
———
110914392030-01-15DS ————
———
110914402030-01-15DP ————
———
110980152030-01-15U U-1617———
———
88777762030-10-08DS/DP/U U-1617———
———
112983492032-02-10DP ————
———
121280392032-02-10DP/U U-1617———
———
97177202032-02-10DP ————
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
ODE-33—2019-11-29Historical Orange Book exclusivity; scope and start date not independently established————Source

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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 (1)
TypeDateRoleBasisSource
REGULATORY_STATUS2026-08-14CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXISTSource
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.