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Product profile · United States

IQIRVO

 ·  Patent Litigation & Settlement History ↓

IngredientELAFIBRANOR
Application typeNDA
Application218860
Product001
Dosage formTABLET
RouteORAL
Strength80MG
Approval date2024-06-10
Marketing statusPrescription
Status event—
ApplicantIPSEN
Product source

Current GenericRadar decision

Year2037
SelectionDEEP_REVIEW
ReviewFINAL_CHECKING
Anchor typeDS_EQUIVALENT
Anchor date2037-03-30
Patent anchor2037-03-30
Exclusivity anchor2031-06-10
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2037. Anchor type: DS_EQUIVALENT. Patent anchor: 2037-03-30. Exclusivity anchor: 2031-06-10. Anchor date: 2037-03-30. Patent tail: yes. Exclusivity tail: no. Review status: FINAL_CHECKING. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
111855192037-03-30U U-3955———
———
113312922037-03-30U U-1854———
———
118502232037-03-30U U-1854———
———
118575232037-03-30U U-3955———
———
122330382037-03-30U U-1854———
———
122959272037-03-30U U-1854———
———
122959282037-03-30U U-1854———
———
123109352037-03-30U U-1854———
———
125890862037-03-30U U-4473———
———
126730352044-03-05DP/U U-1854———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE—2029-06-10————Source
ODE-486—2031-06-10————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.
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.