Ferric citrate - Generic Drug Details

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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and twenty-one 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:	121
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	34
Patent Applications:	3,590
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

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

Dosage:

TABLET;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 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

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

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			Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes			Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes			Y	Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes			Y
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes

Expired US Patents for ferric citrate

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

International Patents for ferric citrate

Country	Patent Number	Title	Estimated Expiration
Portugal	1601680
Eurasian Patent Organization	200800593	ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ ТРЕХВАЛЕНТНОГО ЖЕЛЕЗА ФАРМАЦЕВТИЧЕСКОГО КАЧЕСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ
Israel	189583	תרכובות פרמצבטיות המכילות ברזל ציטרט, ושימושן להכנת תרופות להפחתת רמות פוספט בסרום לטיפול או הקלה של הפרעות הקשורות לסידן (Pharmaceutical compositions comprising ferric citrate and uses thereof for the preparation of medicaments for reducing serum phosphate levels and treating or ameliorating calcium-associated disorders)
Australia	2006279333	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Japan	2016026177	慢性腎疾患の治療法 (METHOD OF TREATING CHRONIC KIDNEY DISEASE)