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Product profile · United States

IZERVAY

 ·  Patent Litigation & Settlement History ↓

IngredientAVACINCAPTAD PEGOL SODIUM
Application typeNDA
Application217225
Product001
Dosage formSOLUTION
RouteINTRAVITREAL
StrengthEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML)
Approval date2023-08-04
Marketing statusPrescription
Status event—
ApplicantASTELLAS
Product source

Current GenericRadar decision

Year2034
SelectionCANDIDATE
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2034-07-11
Patent anchor2034-07-11
Exclusivity anchor—
Protection date2034-07-11
First Final ANDA—
Status event—

US11273171 c1; GA monthly2mg; corrected2023 claims; sequence/PEG compared.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
82367732026-11-11U U-3673NYDS_EQUIVALENT
———
75794562027-02-14DS —NYDS_EQUIVALENT
———
96175462027-02-14DS/U U-3673YNTRUE_DS
———
112731712034-07-11U U-3673NYDS_EQUIVALENT
———
114911762034-07-11U U-3673NYDS_EQUIVALENT
———
120168752034-07-11U U-3673NNU
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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 (1)
TypeDateRoleBasisSource
ANNUAL_DECISION_RECHECK—ANCHOR_AND_TAILUS11273171 c1; GA monthly2mg; corrected2023 claims; sequence/PEG compared.Source
Decision history
CurrentYearStatusReviewAnchorJudged
Y2034CANDIDATEFINAL2034-07-112026-10-17 20:32:21
N2034CANDIDATEFINAL2034-07-112026-10-15 23:00:04
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.