GenericRadar
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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientSEMAGLUTIDE
Application typeNDA
Application218316
Product004
Dosage formTABLET
RouteORAL
Strength25MG
Approval date2025-12-22
Marketing statusPrescription
Status event—
ApplicantNOVO
Product source

Current GenericRadar decision

Year2031
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2031-12-05
Patent anchor2031-12-05
Exclusivity anchor2028-12-22
Protection date2039-02-01
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:218316:004; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
85361222026-03-20DS/DP —YNTRUE_DS
English description not available.
———
85361222026-03-20ORANGE_BOOK —YNTRUE_DS
English description not available.
———
81293432031-12-05DS/DP —YNTRUE_DS
English description not available.
———
81293432031-12-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
113829572031-12-16DP —NNDP
English description not available.
———
113829572031-12-16ORANGE_BOOK —NNDP
English description not available.
———
92781232031-12-16DP/U U-4389NNDP
English description not available.
———
92781232031-12-16ORANGE_BOOK U-4389NNDP
English description not available.
———
110334992033-06-19DP/U U-4496NNDP
English description not available.
———
110334992033-06-19ORANGE_BOOK U-4496NNDP
English description not available.
———
102789232034-05-02U U-4389NNU
English description not available.
———
102789232034-05-02ORANGE_BOOK U-4389NNU
English description not available.
———
122397392034-05-02U U-4388NNU
English description not available.
———
122397392034-05-02ORANGE_BOOK U-4388NNU
English description not available.
———
118332482039-02-01DP/U U-4387NNDP
English description not available.
———
118332482039-02-01ORANGE_BOOK U-4387NNDP
English description not available.
———
123969532039-02-01DP/U U-4387NNDP
English description not available.
———
123969532039-02-01ORANGE_BOOK U-4387NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
I-9352024-03-082027-03-08English description not available.NN——Source
I-9352024-03-082027-03-08English description not available.NN—
NP
Full coverage date: —
Source
NP2025-12-222028-12-22English description not available.YY2028-12-22—Source
NP2025-12-222028-12-22English description not available.YY2028-12-22
NP
Full coverage date: 2028-12-22
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 (12)
TypeDateRoleBasisSource
PATENT2026-03-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-12-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-12-16FTO_TAILEnglish description not available.Source
PATENT2031-12-16FTO_TAILEnglish description not available.Source
PATENT2033-06-19FTO_TAILEnglish description not available.Source
PATENT2034-05-02FTO_TAILEnglish description not available.Source
PATENT2034-05-02FTO_TAILEnglish description not available.Source
PATENT2039-02-01FTO_TAILEnglish description not available.Source
PATENT2039-02-01FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2031-12-05CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:218316:004; 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.