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Last Updated: March 7, 2021

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VELPHORO Drug Profile

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When do Velphoro patents expire, and what generic alternatives are available?

Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and ten patent family members in thirty-nine countries.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.

US ANDA Litigation and Generic Entry Outlook for Velphoro

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 23, 2030. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for VELPHORO
Drug patent expirations by year for VELPHORO
Drug Prices for VELPHORO

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Generic Entry Opportunity Date for VELPHORO
Generic Entry Date for VELPHORO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, CHEWABLE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VELPHORO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 4
Vifor Fresenius Medical Care Renal PharmaPhase 3
Vifor Fresenius Medical Care Renal PharmaN/A

See all VELPHORO clinical trials

US Patents and Regulatory Information for VELPHORO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vifor Fresenius VELPHORO sucroferric oxyhydroxide TABLET, CHEWABLE;ORAL 205109-001 Nov 27, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vifor Fresenius VELPHORO sucroferric oxyhydroxide TABLET, CHEWABLE;ORAL 205109-001 Nov 27, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vifor Fresenius VELPHORO sucroferric oxyhydroxide TABLET, CHEWABLE;ORAL 205109-001 Nov 27, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vifor Fresenius VELPHORO sucroferric oxyhydroxide TABLET, CHEWABLE;ORAL 205109-001 Nov 27, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vifor Fresenius VELPHORO sucroferric oxyhydroxide TABLET, CHEWABLE;ORAL 205109-001 Nov 27, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VELPHORO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0868125 CA 2015 00007 Denmark   Start Trial PRODUCT NAME: BLANDING AF POLYNUKLEAERT JERN(III)-OXYHYDROXID, SUCROSE OG STIVELSE; REG. NO/DATE: EU/1/14/943/001-004 20140826
0868125 C300710 Netherlands   Start Trial PRODUCT NAME: MENGSEL VAN POLYNUCLEAIRE IJZER (III)-OXYHYDROXIDE, SUCROSE EN ZETMEEL; REGISTRATION NO/DATE: EU/1/14/943 20140826
0868125 C00868125/01 Switzerland   Start Trial PRODUCT NAME: FERRIOXYHYDROXIDUM/SACCHARUM/AMYLA; REGISTRATION NO/DATE: SWISSMEDIC 62986 22.01.2015
0868125 SPC/GB14/087 United Kingdom   Start Trial PRODUCT NAME: MIXTURE OF POLYNUCLEAR IRON(III)OXYHYDROXIDE, SUCROSE AND STARCHES; REGISTERED: UK EU/1/14/943/001 20140828; UK EU/1/14/943/002 20140828; UK EU/1/14/943/003 20140828; UK EU/1/14/943/004 20140828
0868125 425 Finland   Start Trial
0868125 PA2015003 Lithuania   Start Trial PRODUCT NAME: POLICIKLINES GELEZIES (III) OKSIHIDROKSIDO, SACHAROZES IR KRAKMOLU MISINYS; REGISTRATION NO/DATE: EU/1/14/943/001 - EU/1/14/943/004 20140826
0868125 15C0018 France   Start Trial PRODUCT NAME: MELANGE D'OXYHYDROXYDE DE FER (III) POLYNUCLEAIRE,DE SACCHAROSE ET D'AMIDONS.; REGISTRATION NO/DATE: EU/1/14/943/001 20140826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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