GenericRadar
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Published markets; coverage varies by country
Product profile · United States

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

 ·  Patent Litigation & Settlement History ↓

IngredientAVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
Application typeNDA
Application219616
Product001
Dosage formCAPSULE, TABLET
RouteORAL
StrengthEQ 0.8MG BASE;EQ 200MG BASE
Approval date2025-05-08
Marketing statusPrescription
Status event—
ApplicantVERASTEM INC
Product source

Current GenericRadar decision

Year2040
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2040-09-11
Patent anchor2040-09-11
Exclusivity anchor2032-05-08
Protection date2042-12-29
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:219616:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
78977922027-02-09DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
78977922027-02-09ORANGE_BOOK —YNTRUE_DS
English description not available.
———
82474112028-04-17DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
82474112028-04-17ORANGE_BOOK —YNTRUE_DS
English description not available.
———
79281092029-08-21DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
79281092029-08-21ORANGE_BOOK —YNTRUE_DS
English description not available.
———
114000902038-10-29U U-4196NYU
| B1C03P7 issued-claim review2026-10-15: U
———
114000902038-10-29ORANGE_BOOK U-4196NYU
English description not available.
———
115175732040-09-11U U-4205NYU
| B1C03P7 issued-claim review2026-10-15: U
———
115175732040-09-11U U-4196NYU
| B1C03P7 issued-claim review2026-10-15: U
———
115175732040-09-11ORANGE_BOOK U-4196;U-4205NYU
English description not available.
———
118732962042-12-29DP/U U-4196NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
118732962042-12-29ORANGE_BOOK U-4196NNDP
English description not available.
———
125094502042-12-29DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
125094502042-12-29ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-05-082030-05-08English description not available.YY2030-05-08—Source
NCE2025-05-082030-05-08English description not available.YY2030-05-08
ODE-525
Full coverage date: 2030-05-08
Source
ODE-5252025-05-082032-05-08English description not available.YY2032-05-08—Source
ODE-5252025-05-082032-05-08English description not available.YY2032-05-08
ODE-525
Full coverage date: 2032-05-08
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 (10)
TypeDateRoleBasisSource
PATENT2027-02-09HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-04-17HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-08-21HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2040-09-11CANONICAL_ANCHOREnglish description not available.Source
PATENT2042-12-29FTO_TAILEnglish description not available.Source
PATENT2042-12-29FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2040-09-11CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:219616:001; 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.