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

LIVTENCITY

 ·  Patent Litigation & Settlement History ↓

IngredientMARIBAVIR
Application typeNDA
Application215596
Product001
Dosage formTABLET
RouteORAL
Strength200MG
Approval date2021-11-23
Marketing statusPrescription
Status event—
ApplicantTAKEDA PHARMS USA
Product source

Current GenericRadar decision

Year2028
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2028-11-23
Patent anchor—
Exclusivity anchor2028-11-23
Protection date2043-10-11
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:215596:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
124471692031-10-27U U-4329NNU
| B1C03P8 issued-claim review2026-10-15: U
———
124471692031-10-27ORANGE_BOOK U-4329NNU
English description not available.
———
126613682031-10-27U U-4572NNU
| B1C03P8 issued-claim review2026-10-15: U
———
126613682031-10-27ORANGE_BOOK U-4572NNU
English description not available.
———
116846322032-01-04U U-3650NNU
| B1C03P8 issued-claim review2026-10-15: U
———
116846322032-01-04ORANGE_BOOK U-3650NNU
English description not available.
———
122139892042-11-18U U-4137NNU
| B1C03P8 issued-claim review2026-10-15: U
———
122139892042-11-18ORANGE_BOOK U-4137NNU
English description not available.
———
124339072042-11-18U U-4289NNU
| B1C03P8 issued-claim review2026-10-15: U
———
124339072042-11-18ORANGE_BOOK U-4289NNU
English description not available.
———
124471702042-11-18U U-4328NNU
| B1C03P8 issued-claim review2026-10-15: U
———
124471702042-11-18ORANGE_BOOK U-4328NNU
English description not available.
———
122959402043-10-11DS/DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
122959402043-10-11ORANGE_BOOK —NNDP
English description not available.
———
125277712043-10-11DS/DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
125277712043-10-11ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2021-11-232026-11-23English description not available.YY2026-11-23—Source
NCE2021-11-232026-11-23English description not available.YY2026-11-23
ODE-388
Full coverage date: 2026-11-23
Source
ODE-3882021-11-232028-11-23English description not available.YY2028-11-23—Source
ODE-3882021-11-232028-11-23English description not available.YY2028-11-23
ODE-388
Full coverage date: 2028-11-23
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
PATENT2031-10-27FTO_TAILEnglish description not available.Source
PATENT2031-10-27FTO_TAILEnglish description not available.Source
PATENT2032-01-04FTO_TAILEnglish description not available.Source
PATENT2042-11-18FTO_TAILEnglish description not available.Source
PATENT2042-11-18FTO_TAILEnglish description not available.Source
PATENT2042-11-18FTO_TAILEnglish description not available.Source
PATENT2043-10-11FTO_TAILEnglish description not available.Source
PATENT2043-10-11FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_STATUS2028-11-23CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:215596:001; 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.