GenericRadar
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Product profile · United States

TEPMETKO

 ·  Patent Litigation & Settlement History ↓

IngredientTEPOTINIB HYDROCHLORIDE
Application typeNDA
Application214096
Product001
Dosage formTABLET
RouteORAL
StrengthEQ 225MG BASE
Approval date2021-02-03
Marketing statusPrescription
Status event—
ApplicantEMD SERONO INC
Product source

Current GenericRadar decision

Year2030
SelectionCANDIDATE
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2030-03-19
Patent anchor2030-03-19
Exclusivity anchor2028-02-03
Protection date2030-03-19
First Final ANDA—
Status event—

NO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:214096:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
92843002028-04-29DP —NYU
| B1C03P8 issued-claim review2026-10-15: U
———
92843002028-04-29ORANGE_BOOK —NYU
English description not available.
———
89213572028-05-30DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
89213572028-05-30ORANGE_BOOK —YNTRUE_DS
English description not available.
———
86586432028-07-04U U-3077NYU
| B1C03P8 issued-claim review2026-10-15: U
———
86586432028-07-04ORANGE_BOOK U-3077NYU
English description not available.
———
90620292028-07-04DP —NYU
| B1C03P8 issued-claim review2026-10-15: U
———
90620292028-07-04ORANGE_BOOK —NYU
English description not available.
———
94037992028-07-04U U-3077NYU
| B1C03P8 issued-claim review2026-10-15: U
———
94037992028-07-04ORANGE_BOOK U-3077NYU
English description not available.
———
89275402028-07-21U U-3078NYU
| B1C03P8 issued-claim review2026-10-15: U
———
89275402028-07-21ORANGE_BOOK U-3078NYU
English description not available.
———
83296922029-10-30DS/DP —NYU
| B1C03P8 issued-claim review2026-10-15: U
———
83296922029-10-30ORANGE_BOOK —NYU
English description not available.
———
85807812030-03-19DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
85807812030-03-19ORANGE_BOOK —YNTRUE_DS
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2021-02-032026-02-03English description not available.YY2026-02-03—Source
NCE2021-02-032026-02-03English description not available.YY2026-02-03
ODE-325
Full coverage date: 2026-02-03
Source
ODE-3252021-02-032028-02-03English description not available.YY2028-02-03—Source
ODE-3252021-02-032028-02-03English description not available.YY2028-02-03
ODE-325
Full coverage date: 2028-02-03
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
PATENT2028-04-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-05-30HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-07-04HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-07-04HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-07-04HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-07-21HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-10-30HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-03-19CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2030-03-19CANONICAL_DECISIONNO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:214096:001; 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.