GenericRadar
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Product profile · United States

KOMZIFTI

 ·  Patent Litigation & Settlement History ↓

IngredientZIFTOMENIB
Application typeNDA
Application220305
Product001
Dosage formCAPSULE
RouteORAL
Strength200MG
Approval date2025-11-13
Marketing statusPrescription
Status event—
ApplicantKURA
Product source

Current GenericRadar decision

Year2037
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2037-03-15
Patent anchor2037-03-15
Exclusivity anchor2030-11-13
Protection date2044-07-16
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:220305:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100772712036-03-16DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
100772712036-03-16ORANGE_BOOK —YNTRUE_DS
English description not available.
———
101740412036-03-16U U-4350NYU
| B1C03P8 issued-claim review2026-10-15: U
———
101740412036-03-16U U-4354NYU
| B1C03P8 issued-claim review2026-10-15: U
———
101740412036-03-16ORANGE_BOOK U-4350;U-4354NYU
English description not available.
———
108698682037-01-26U U-4353NNU
| B1C03P8 issued-claim review2026-10-15: U
———
108698682037-01-26U U-4352NNU
| B1C03P8 issued-claim review2026-10-15: U
———
108698682037-01-26ORANGE_BOOK U-4352;U-4353NNU
English description not available.
———
107812182037-03-15DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
107812182037-03-15ORANGE_BOOK —YNTRUE_DS
English description not available.
———
116738982037-03-15U U-4351NYU
| B1C03P8 issued-claim review2026-10-15: U
———
116738982037-03-15U U-4350NYU
| B1C03P8 issued-claim review2026-10-15: U
———
116738982037-03-15ORANGE_BOOK U-4350;U-4351NYU
English description not available.
———
119446272038-09-06U U-4347NNU
| B1C03P8 issued-claim review2026-10-15: U
———
119446272038-09-06U U-4349NNU
| B1C03P8 issued-claim review2026-10-15: U
———
119446272038-09-06ORANGE_BOOK U-4347;U-4349NNU
English description not available.
———
124101842044-07-16DS/DP/U U-4347NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
124101842044-07-16DS/DP/U U-4348NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
124101842044-07-16ORANGE_BOOK U-4347;U-4348NNDP
English description not available.
———
125213962044-07-16DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
125213962044-07-16ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-11-132030-11-13English description not available.YY2030-11-13—Source
NCE2025-11-132030-11-13English description not available.YY2030-11-13
NCE
Full coverage date: 2030-11-13
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 (11)
TypeDateRoleBasisSource
PATENT2036-03-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2036-03-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-01-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-03-15CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-03-15CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-09-06FTO_TAILEnglish description not available.Source
PATENT2044-07-16FTO_TAILEnglish description not available.Source
PATENT2044-07-16FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS—REGULATORY_SCOPE_CONTEXTFDA OOPD exclusivity end date TBD; no invented term; excluded from granted-right anchorSource
REGULATORY_STATUS2037-03-15CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:220305:001; 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.