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Last Updated: June 7, 2024

FERRIC CITRATE - Generic Drug Details

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What are the generic sources for ferric citrate and what is the scope of freedom to operate?

Ferric citrate is the generic ingredient in one branded drug marketed by Keryx Biopharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and twenty-two patent family members in twenty-three countries.

There are six drug master file entries for ferric citrate. One supplier is listed for this compound.

Summary for FERRIC CITRATE

International Patents:	122
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	34
Patent Applications:	2,751
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERRIC CITRATE
What excipients (inactive ingredients) are in FERRIC CITRATE?	FERRIC CITRATE excipients list
DailyMed Link:	FERRIC CITRATE at DailyMed

Recent Clinical Trials for FERRIC CITRATE

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

Sponsor	Phase
USRC Kidney Research	Phase 3
Akebia Therapeutics	Phase 3
USRC Kidney Research	Phase 4

See all FERRIC CITRATE clinical trials

Pharmacology for FERRIC CITRATE

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for FERRIC CITRATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FERRIC CITRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FERRIC CITRATE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007089571		⤷ Sign Up
European Patent Office	3066923	MÉTHODE DE TRAITEMENT DE NÉPHROPATHIE CHRONIQUE (METHOD OF TREATING CHRONIC KIDNEY DISEASE)	⤷ Sign Up
China	101253186	Ferric organic compounds, uses thereof and methods of making same	⤷ Sign Up
European Patent Office	1601680	PROCEDES DE FABRICATION DES COMPOSES ORGANIQUES FERRIQUES (METHODS OF MAKING FERRIC ORGANIC COMPOUNDS)	⤷ Sign Up
Japan	2009525277		⤷ Sign Up
Spain	2539635		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.