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Last Updated: June 3, 2020

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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 three patents protecting this drug.

This drug has ninety-five patent family members in thirty-eight 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 has been one patent litigation case 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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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

Recent Litigation for VELPHORO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA2018-03-12

See all VELPHORO litigation

Synonyms for VELPHORO
Colliron I.V.
DB09146
EINECS 232-464-7
Encifer
Fe-back
Fe-lib
Feojectin
Ferijet
Ferosoft S
Ferplex SS
FERRIC HYDROXIDE SUCROSE COMPLEX
Ferric oxide, saccharated
Ferric saccharate ...iron oxide (mix.)
Ferrivenin
Ferrum Hausmann i.v.
Ferrum Vitis
Ferum Hausmann
Fesin
FZ7NYF5N8L
Hippiron
IRON OXIDE SACCHARATED
Iron oxide, saccharated
Iron sucrose
Iron sucrose [USAN:USP:BAN]
IRON SUCROSE COMPLEX
Iron sugar
IRON(III) HYDROXIDE SUCROSE COMPLEX
Iviron
Neo-ferrum
Proferrin
Q27888379
Saccharated ferric oxide
Saccharated iron
Saccharated iron oxide
Succharated ferric oxide
Succharated ferric oxide [USAN:JAN]
Sucrofer
Sucroferric oxyhydroxide
Sucrose, iron complex
UNII-FZ7NYF5N8L
Venofer
Venoferrum
XI 921
XI-921

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
>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 C00868125/01 Switzerland   Start Trial PRODUCT NAME: FERRIOXYHYDROXIDUM/SACCHARUM/AMYLA; REGISTRATION NO/DATE: SWISSMEDIC 62986 22.01.2015
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Harvard Business School
Express Scripts
McKinsey
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.