Ferric citrate - Generic Drug Details

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What are the generic drug 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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and thirty-six patent family members in twenty-six countries.

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

Summary for ferric citrate

International Patents:	136
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	34
Patent Applications:	3
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
Akebia Therapeutics	Phase 3
USRC Kidney Research	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

Anatomical Therapeutic Chemical (ATC) Classes for ferric citrate

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
>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
Spain	2699447		See Plans and Pricing
Japan	6368186		See Plans and Pricing
Japan	2009504777		See Plans and Pricing
European Patent Office	2456426	FORMES POSOLOGIQUES DE CITRATE FERRIQUE (FERRIC CITRATE DOSAGE FORMS)	See Plans and Pricing
Japan	2009525276		See Plans and Pricing
Israel	228952	שימוש בתכשירים המכילים ברזל ציטראט להכנת תרופות להפחתת רמות פוספט בנסיוב (Use of compositions comprising ferric citrate for the preparation of medicaments for reducing serum phosphate levels)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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