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AURYXIA Drug Profile

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When do Auryxia patents expire, and when can generic versions of Auryxia launch?

Auryxia is a drug marketed by Keryx Biopharms and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and eighteen patent family members in twenty-six countries.

The generic ingredient in AURYXIA is ferric citrate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric citrate profile page.

Summary for AURYXIA

International Patents:	118
US Patents:	14
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	32
Clinical Trials:	5
Patent Applications:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AURYXIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AURYXIA
DailyMed Link:	AURYXIA at DailyMed

Generic Entry Opportunity Date for AURYXIA

NDA:

205874

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.

Pharmacology for AURYXIA

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

Synonyms for AURYXIA

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)

11084-12-1

1185-57-5

12386-83-3

12549-57-4

17217-76-4 (trihydrate)

2-hydroxy-1,2,3-propanetricarboxylic acid iron salt

2-hydroxypropane-1,2,3-tricarboxylate; iron(3+)

23087-37-8

2338-05-8

2338-05-8 (unspecified iron salt)

28633-45-6

28633-45-6 (unspecified iron(+3) salt)

3522-50-7

3522-50-7 (Parent)

3B1-003934

47516-89-2

57979-58-5 (dihydrate)

6043-74-9

62709-48-2

63G354M39Z

7705-15-9

A832727

AC1L1UYI

ACM28633456

AKOS015918266

AN-19905

C6H5FeO7

CCRIS 6843

Citric acid iron(III) salt

Citric acid, iron salt

Citric acid, iron(3+) salt

Citric acid, iron(3+) salt (1:1)

CTK1C2869

D04CJL

DB09162

DTXSID0037657

EINECS 222-536-6

EINECS 249-117-0

Fe(III)-citrate complex (1:1)

FERRIC CITRATE

Ferric citrate (VAN)

Ferric citrate [USAN]

FERRICCITRATE

ferrum citricum

FT-0626407

FT-0627304

FT-0652224

H260

Hyperphosphatemia therapy, Panion/Keryx

I14-60931

I14-8077

Iron (III) citrate

Iron 2-hydroxy-1,2,3-propanetricarboxylate

Iron citrate

Iron citrate, FeC6H5O7

Iron, (hydrogen citrato(3-))-

iron(3+) citrate

iron(3+) ion 2-hydroxypropane-1,2,3-tricarboxylate

iron(3+); 2-oxidanylpropane-1,2,3-tricarboxylate

Iron(III) citrate

Iron(III) citrate tribasic

Iron(III)-citrate

JTT 751

JTT-751

KRX-0502

KS-0000108D

MCULE-2140052675

Nephoxil

NPFOYSMITVOQOS-UHFFFAOYSA-K

NSC 112227

OR020149

OR253005

PBF-1681

SCHEMBL42945

TR-037246

TRA0022730

UNII-63G354M39Z

Zerenex

US Patents and Regulatory Information for AURYXIA

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
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

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Non-Orange Book US Patents for AURYXIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,913,821	Ferric organic compounds, uses thereof and methods of making same
9,750,715	Method of reversing, preventing, delaying or stabilizing soft tissue calcification
9,889,113	Method for reversing, preventing, delaying or stabilizing soft tissue calcification

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International Patents for AURYXIA

Country	Document Number	Estimated Expiration
Taiwan	200740431
European Patent Office	1931689
Slovenia	1601680