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Product profile · United States

VITRAKVI

 ·  Patent Litigation & Settlement History ↓

IngredientLAROTRECTINIB SULFATE
Application typeNDA
Application211710
Product001
Dosage formSOLUTION
RouteORAL
StrengthEQ 20MG BASE/ML
Approval date2018-11-26
Marketing statusPrescription
Status event—
ApplicantBAYER HEALTHCARE
Product source

Current GenericRadar decision

Year2029
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2029-12-23
Patent anchor2029-12-23
Exclusivity anchor2025-11-26
Protection date—
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100057832029-10-21U U-2472NNU
———
100470972029-10-21U U-2474NNU
———
107740852029-10-21U U-2470NYDS_EQUIVALENT
———
88656982029-10-21U U-2469NYDS_EQUIVALENT
———
91270132029-10-21DS/DP —YNTRUE_DS
———
94471042029-10-21U U-2470NYDS_EQUIVALENT
———
96767832029-10-21U U-2469NYDS_EQUIVALENT
———
85132632029-12-23DS/DP —YNTRUE_DS
———
101728612035-11-16DS —NNDP
———
97824142035-11-16U U-2471NNU
———
107995052036-08-15DS —NNDP
———
100459912037-04-04U U-2473NNU
———
101371272037-04-04DP —NNDP
———
106680722037-04-04DP —NNDP
———
111917662037-04-04U U-2471NNU
———
114845352037-04-04U U-2470NNU
———
113379672037-05-16U U-4123NNU
———
119749982037-05-16U U-4124NNU
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

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_STATUS2029-12-23CANONICAL_DECISIONPOST_ANCHOR_RIGHTSSource
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.