VELPHORO Drug Patent Profile

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 fifteen 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

Summary for VELPHORO

International Patents:	115
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for VELPHORO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELPHORO
What excipients (inactive ingredients) are in VELPHORO?	VELPHORO excipients list
DailyMed Link:	VELPHORO at DailyMed

See drug prices for VELPHORO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VELPHORO

NDA:

205109

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

Sponsor	Phase
University of Colorado, Denver	Phase 4
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Vifor Fresenius Medical Care Renal Pharma	Phase 2

See all VELPHORO clinical trials

Pharmacology for VELPHORO

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for VELPHORO

VELPHORO is protected by eleven US patents.

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

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					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y

Expired US Patents for VELPHORO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013

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

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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
Russian Federation	2013128356	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОКСИГИДРОКСИД ЖЕЛЕЗА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ
European Patent Office	3895698	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'OXYHROXYDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)
Croatia	P20181837
Lithuania	3492069

Supplementary Protection Certificates for VELPHORO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0868125	15C0018	France		PRODUCT NAME: MELANGE D'OXYHYDROXYDE DE FER (III) POLYNUCLEAIRE,DE SACCHAROSE ET D'AMIDONS.; REGISTRATION NO/DATE: EU/1/14/943/001 20140826
0868125	SPC/GB14/087	United Kingdom		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	PA2015003	Lithuania		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	425	Finland