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

RIVFLOZA

 ·  Patent Litigation & Settlement History ↓

IngredientNEDOSIRAN SODIUM
Application typeNDA
Application215842
Product003
Dosage formSOLUTION
RouteINJECTION
StrengthEQ 160MG BASE/ML (EQ 160MG BASE/ML)
Approval date2023-09-29
Marketing statusPrescription
Status event—
ApplicantNOVO
Product source

Current GenericRadar decision

Year2038
SelectionCANDIDATE
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2038-10-12
Patent anchor2038-10-12
Exclusivity anchor2032-03-27
Protection date2038-10-12
First Final ANDA—
Status event—

ANCHOR_NO_TAIL; US:NDA:215842:003; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103518542035-10-09DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
103518542035-10-09ORANGE_BOOK —YNTRUE_DS
English description not available.
———
107383112035-10-09DS/DP/U U-3709NYU
| B1C03 issued-claim review2026-10-15: U
———
107383112035-10-09ORANGE_BOOK U-3709NYU
English description not available.
———
113592032035-10-09DS/DP/U U-3709YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
113592032035-10-09ORANGE_BOOK U-3709YNTRUE_DS
English description not available.
———
110535022035-10-29DS/DP —YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
110535022035-10-29ORANGE_BOOK —YNTRUE_DS
English description not available.
———
112864882038-10-12DS/DP/U U-3709YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
112864882038-10-12ORANGE_BOOK U-3709YNTRUE_DS
English description not available.
———
116616042038-10-12DS/DP/U U-3709YNTRUE_DS
| B1C03 issued-claim review2026-10-15: TRUE_DS
———
116616042038-10-12ORANGE_BOOK U-3709YNTRUE_DS
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NPP2025-03-272028-03-27English description not available.NN——Source
NPP2025-03-272028-03-27English description not available.NN—
ODE-443 + ODE-531
Full coverage date: —
Source
NCE2023-09-292028-09-29English description not available.YY2028-09-29—Source
NCE2023-09-292028-09-29English description not available.YY2028-09-29
ODE-443 + ODE-531
Full coverage date: 2028-09-29
Source
ODE-4432023-09-292030-09-29English description not available.NN——Source
ODE-4432023-09-292030-09-29English description not available.NN—
ODE-443 + ODE-531
Full coverage date: —
Source
ODE-5312025-03-272032-03-27English description not available.NN——Source
ODE-5312025-03-272032-03-27English description not available.NN—
ODE-443 + ODE-531
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 (11)
TypeDateRoleBasisSource
PATENT2035-10-09HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-10-09HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-10-09HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-10-29HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-10-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-10-12CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-10-12CANONICAL_DECISIONANCHOR_NO_TAIL; US:NDA:215842:003; 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.