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-one patent family members in twenty-six countries.

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

Summary for ferric citrate

International Patents:	131
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	20
Suppliers / Packagers:	1
Bulk Api Vendors:	38
Clinical Trials:	25
Patent Applications:	3
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric citrate
DailyMed Link:	ferric citrate at DailyMed

Recent Clinical Trials for ferric citrate

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

Sponsor	Phase
Rockwell Medical Technologies, Inc.	Phase 3
Shandong Weigao Panion Pharmaceutical Co. Ltd.	Phase 3
Sreedhar Mandayam	Phase 4

See all ferric citrate clinical trials

Recent Litigation for ferric citrate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
In re: Auryxia (Ferric Citrate) Patent Litigation	2019-07-31
Keryx Biopharmaceuticals, Inc. v. Lupin Ltd.	2019-05-10
Keryx Biopharmaceuticals, Inc. v. Chemo Research S.L.	2019-02-01

See all ferric citrate litigation

Pharmacology for ferric citrate

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

Synonyms for ferric citrate

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron salt
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron salt (1:?)
1,2,3-propanetricarboxylic acid, 2-hydroxy-, iron(2+) salt (2:3)
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron(3+) salt
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron(3+) salt (1:1)
1185-57-5
2-hydroxy-1,2,3-propanetricarboxylic acid iron salt
2-hydroxypropane-1,2,3-tricarboxylate; iron(3+)
2338-05-8
28633-45-6
3522-50-7
6043-74-9
63G354M39Z
A832727
ACM28633456
AKOS015918266
Auryxia
BCP30645
C6H5FeO7
CCRIS 6843
Citric acid, iron salt
Citric acid, iron(3+) salt
Citric acid, iron(3+) salt (1:1)
CTK1C2869
DB-119245
DB09162
DTXSID0037657
EINECS 222-536-6
EINECS 249-117-0
Fe(III)-citrate complex (1:1)
Ferric citrate (VAN)
Ferric citrate [USAN]
FERROUS CITRATE
ferrum citricum
FT-0626407
FT-0627304
FT-0652224
H260
Iron (III) citrate
Iron 2-hydroxy-1,2,3-propanetricarboxylate
Iron citrate
Iron citrate, FeC6H5O7
Iron, (hydrogen citrato(3-))-
iron(3+) citrate
iron(3+); 2-oxidanylpropane-1,2,3-tricarboxylate
Iron(III) citrate
Iron(III) citrate tribasic
Iron(III) citrate;Iron citrate
Iron(III)-citrate
iron(iii)citrate
JTT 751
KRX-0502
KS-0000108D
MCULE-2140052675
NPFOYSMITVOQOS-UHFFFAOYSA-K
NSC 112227
Q15628111
SCHEMBL42945
TR-037246
TRA0022730
UNII-63G354M39Z
Zerenex

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

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Country	Patent Number	Estimated Expiration
Portugal	1601680	Start Trial
Taiwan	I670086	Start Trial
Australia	723091	Start Trial
Israel	228952	Start Trial
South Korea	20080094013	Start Trial
South Korea	101665968	Start Trial
>Country	>Patent Number	>Estimated Expiration

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