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Product profile · United States

VERQUVO

 ·  Patent Litigation & Settlement History ↓

IngredientVERICIGUAT
Application typeNDA
Application214377
Product003
Dosage formTABLET
RouteORAL
Strength10MG
Approval date2021-01-19
Marketing statusPrescription
Status event—
ApplicantMSD
Product source

Current GenericRadar decision

Year2031
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2031-05-19
Patent anchor2031-05-19
Exclusivity anchor2026-01-19
Protection date2032-11-26
First Final ANDA—
Status event—

ANCHOR_WITH_TAIL; US:NDA:214377:003; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
107368962031-05-19DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
107368962031-05-19ORANGE_BOOK —YNTRUE_DS
English description not available.
———
114396422031-05-19U U-3062NYU
| B1C03 issued-claim review2026-10-15: U
———
114396422031-05-19ORANGE_BOOK U-3062NYU
English description not available.
———
84206562031-05-19DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
84206562031-05-19ORANGE_BOOK —YNTRUE_DS
English description not available.
———
89213772031-05-19U U-3062NYU
| B1C03 issued-claim review2026-10-15: U
———
89213772031-05-19ORANGE_BOOK U-3062NYU
English description not available.
———
99934762031-05-19U U-3062NYU
| B1C03 issued-claim review2026-10-15: U
———
99934762031-05-19ORANGE_BOOK U-3062NYU
English description not available.
———
96049482032-11-26DS/DP/U U-3062NNDP
| B1C03 issued-claim review2026-10-15: DP
———
96049482032-11-26ORANGE_BOOK U-3062NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2021-01-192026-01-19English description not available.YY2026-01-19—Source
NCE2021-01-192026-01-19English description not available.YY2026-01-19
NCE
Full coverage date: 2026-01-19
Source
D-1982026-01-212029-01-21English description not available.NN——Source
D-1982026-01-212029-01-21English description not available.NN—
NCE
Full coverage date: —
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 (9)
TypeDateRoleBasisSource
PATENT2031-05-19CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-05-19CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-05-19CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-05-19CANONICAL_ANCHOREnglish description not available.Source
PATENT2031-05-19CANONICAL_ANCHOREnglish description not available.Source
PATENT2032-11-26FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2031-05-19CANONICAL_DECISIONANCHOR_WITH_TAIL; US:NDA:214377:003; 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.