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Last Updated: July 16, 2024

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VELPHORO Drug Patent 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 eleven patents protecting this drug.

This drug has one hundred and twenty-one patent family members in thirty-five countries.

The generic ingredient in VELPHORO is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

DrugPatentWatch® Generic Entry Outlook for Velphoro

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

There have been six 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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Drug patent expirations by year for VELPHORO
Drug Prices for VELPHORO

See drug prices for VELPHORO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Prim. Priv. Doz. Dr. Daniel CejkaPhase 2
Vifor Fresenius Medical Care Renal PharmaPhase 2

See all VELPHORO clinical trials

Pharmacology for VELPHORO
Drug ClassPhosphate Binder
Mechanism of ActionPhosphate Chelating Activity

US Patents and Regulatory Information for VELPHORO

VELPHORO is protected by eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VELPHORO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VELPHORO

Pharmaceutical composition, comprising phosphate binder particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition, comprising phosphate binder particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition, comprising phosphate binder particles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

International Patents for VELPHORO

When does loss-of-exclusivity occur for VELPHORO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9312
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE BETA OXIHIDROXIDO DE HIERRO EN ALTA CARGA EN FORMA ADECUADA PARA ADMINISTARCION ORAL Y QUE CONTIENE AL MENOS UN HIDRATO DE CARBONO Y/O ACIDO HUMICO Y SU USO EN EL TRATAMIENTO DE PACIENTES CON HIPERFOSFATEMIA Y CON INSUFICIENCIA RENAL CRONICA , Y PROCEDIMENTO PA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08322963
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0820308
Patent: Composições farmacêuticas
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 00444
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1861146
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷  Sign Up

Patent: 4688702
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Patent: 6619710
Patent: 药物组合物 (Pharmaceutical compositions)
Estimated Expiration: ⤷  Sign Up

Patent: 1789820
Patent: 药物组合物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 2022796
Patent: 药物组合物 (Pharmaceutical compositions)
Estimated Expiration: ⤷  Sign Up

Patent: 2022821
Patent: 药物组合物 (Pharmaceutical compositions)
Estimated Expiration: ⤷  Sign Up

Patent: 2022822
Patent: 药物组合物 (Pharmaceutical compositions)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80398
Patent: COMPOSICIONES FARMACEUTICAS QUE CONTIENEN OXIHIDROXIDO DE HIERRO EN ALTA CARGA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170034
Estimated Expiration: ⤷  Sign Up

Patent: 0181837
Estimated Expiration: ⤷  Sign Up

Patent: 0220318
Estimated Expiration: ⤷  Sign Up

Patent: 0230588
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18496
Estimated Expiration: ⤷  Sign Up

Patent: 21230
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 22285
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Estimated Expiration: ⤷  Sign Up

Patent: 95699
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 22285
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENNANT OXY-HYDROXIDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 95698
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'OXYHROXYDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)
Estimated Expiration: ⤷  Sign Up

Patent: 95699
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'OXYHROXYDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)
Estimated Expiration: ⤷  Sign Up

Patent: 95700
Patent: COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'OXYHYDROXYDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 95699
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1000144
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 07298
Patent: 藥物組合物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31293
Estimated Expiration: ⤷  Sign Up

Patent: 41429
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5726
Patent: תכשירי רוקחות המיכילים אוקסי-הידרוקסיד של ברזל (Pharmaceutical compositions comprising iron oxy-hydroxide)
Estimated Expiration: ⤷  Sign Up

Patent: 7741
Patent: תכשירי רוקחות המכילים ברזל אוקסו - הידרוקסיד, שיטות להכנתם והשימושים בהם (Pharmaceutical compositions comprising iron oxy-hydroxide, methods for the preparation thereof and their uses)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 66164
Estimated Expiration: ⤷  Sign Up

Patent: 61601
Estimated Expiration: ⤷  Sign Up

Patent: 94260
Estimated Expiration: ⤷  Sign Up

Patent: 38734
Estimated Expiration: ⤷  Sign Up

Patent: 64959
Estimated Expiration: ⤷  Sign Up

Patent: 16055
Estimated Expiration: ⤷  Sign Up

Patent: 11503148
Estimated Expiration: ⤷  Sign Up

Patent: 14062120
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Patent: 15166359
Patent: 医薬組成物 (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 17114873
Patent: 医薬組成物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 19089805
Patent: 医薬組成物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 21001192
Patent: 医薬組成物 (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 23011873
Patent: 医薬組成物
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 22285
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 6383
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Patent: 3729
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10005346
Patent: COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 898
Patent: تراكيب صيدلانية
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5435
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015500727
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 22285
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Estimated Expiration: ⤷  Sign Up

Patent: 95699
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 22285
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Estimated Expiration: ⤷  Sign Up

Patent: 95699
Estimated Expiration: ⤷  Sign Up

Patent: 95700
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 93831
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 48760
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОКСИГИДРОКСИД ЖЕЛЕЗА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ (PHARMACEUTICAL COMPOSITION COMPRISING IRON OXY-HYDROXIDE, METHOD OF PRODUCTION THEREOF AND USE)
Estimated Expiration: ⤷  Sign Up

Patent: 10124424
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷  Sign Up

Patent: 13128356
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОКСИГИДРОКСИД ЖЕЛЕЗА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 2340044
Patent: تركيب صيدلاني يشتمل على أكسي هيدروكسيد الحديد بحمولة عالية على شكل ملائم للإعطاء عن طريق الفم (Pharmaceutical compositions comprising iron oxyhydroxide in high loading in a form suitable for oral administration)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 8789
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 22285
Estimated Expiration: ⤷  Sign Up

Patent: 43992
Estimated Expiration: ⤷  Sign Up

Patent: 92069
Estimated Expiration: ⤷  Sign Up

Patent: 95699
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1004256
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1438071
Estimated Expiration: ⤷  Sign Up

Patent: 1590115
Estimated Expiration: ⤷  Sign Up

Patent: 100126266
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Patent: 130030306
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 12331
Estimated Expiration: ⤷  Sign Up

Patent: 03158
Estimated Expiration: ⤷  Sign Up

Patent: 08719
Estimated Expiration: ⤷  Sign Up

Patent: 50337
Estimated Expiration: ⤷  Sign Up

Patent: 51457
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 68167
Estimated Expiration: ⤷  Sign Up

Patent: 92159
Estimated Expiration: ⤷  Sign Up

Patent: 0938210
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷  Sign Up

Patent: 1509423
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000152
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VELPHORO around the world.

Country Patent Number Title Estimated Expiration
Poland 3895699 ⤷  Sign Up
Cyprus 1118496 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2015078900 ⤷  Sign Up
Russian Federation 2010124424 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ⤷  Sign Up
Slovenia 3073997 ⤷  Sign Up
Lithuania 2222285 ⤷  Sign Up
Saudi Arabia 112340044 تركيب صيدلاني يشتمل على أكسي هيدروكسيد الحديد بحمولة عالية على شكل ملائم للإعطاء عن طريق الفم (Pharmaceutical compositions comprising iron oxyhydroxide in high loading in a form suitable for oral administration) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VELPHORO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0868125 PA2015003 Lithuania ⤷  Sign Up 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 SPC/GB14/087 United Kingdom ⤷  Sign Up 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 C00868125/01 Switzerland ⤷  Sign Up PRODUCT NAME: FERRIOXYHYDROXIDUM/SACCHARUM/AMYLA; REGISTRATION NO/DATE: SWISSMEDIC 62986 22.01.2015
0868125 425 Finland ⤷  Sign Up
0868125 C300710 Netherlands ⤷  Sign Up PRODUCT NAME: MENGSEL VAN POLYNUCLEAIRE IJZER (III)-OXYHYDROXIDE, SUCROSE EN ZETMEEL; REGISTRATION NO/DATE: EU/1/14/943 20140826
0868125 15C0018 France ⤷  Sign Up PRODUCT NAME: MELANGE D'OXYHYDROXYDE DE FER (III) POLYNUCLEAIRE,DE SACCHAROSE ET D'AMIDONS.; REGISTRATION NO/DATE: EU/1/14/943/001 20140826
0868125 CA 2015 00007 Denmark ⤷  Sign Up PRODUCT NAME: BLANDING AF POLYNUKLEAERT JERN(III)-OXYHYDROXID, SUCROSE OG STIVELSE; REG. NO/DATE: EU/1/14/943/001-004 20140826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.