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Product profile · United States

VELPHORO

 ·  Patent Litigation & Settlement History ↓

IngredientFERRIC OXYHYDROXIDE
Application typeNDA
Application205109
Product001
Dosage formTABLET, CHEWABLE
RouteORAL
StrengthEQ 500MG IRON
Approval date2013-11-27
Marketing statusPrescription
Status event—
ApplicantVIFOR FRESENIUS
Product source

Current GenericRadar decision

Year2030
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDRUG_SUBSTANCE
Anchor date2030-07-23
Patent anchor2030-07-23
Exclusivity anchor2028-01-01
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2030. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2030-07-23. Exclusivity anchor: 2028-01-01. Anchor date: 2030-07-23. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. 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
106823762028-11-13DP ————
———
106953672028-11-13DP ————
———
109258962028-11-13DP ————
———
109258972028-11-13DP ————
———
109330902028-11-13DP ————
———
110137612028-11-13DP ————
———
110137622028-11-13DP ————
———
106823762029-05-13— ————
—2029-05-13—
106953672029-05-13— ————
—2029-05-13—
109258962029-05-13— ————
—2029-05-13—
109258972029-05-13— ————
—2029-05-13—
109330902029-05-13— ————
—2029-05-13—
110137612029-05-13— ————
—2029-05-13—
110137622029-05-13— ————
—2029-05-13—
95612512030-01-23DP/U U-1468———
———
95612512030-07-23— ————
—2030-07-23—
106248552034-11-26DP ————
———
112349382034-11-26DP ————
———
114462522034-11-26DP ————
———
106248552035-05-26— ————
—2035-05-26—
112349382035-05-26— ————
—2035-05-26—
114462522035-05-26— ————
—2035-05-26—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NPP—2027-07-01————Source
PED—2028-01-01————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.