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AURYXIA Drug Profile

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Which patents cover Auryxia, and when can generic versions of Auryxia launch?

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

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

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

US ANDA Litigation and Generic Entry Outlook for Auryxia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 18, 2024. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for AURYXIA

International Patents:	133
US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	67
Clinical Trials:	7
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

See drug prices for AURYXIA

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.

Recent Clinical Trials for AURYXIA

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

Sponsor	Phase
Akebia Therapeutics	Phase 1
Sreedhar Mandayam	Phase 4
Kaiser Permanente	Phase 4

See all AURYXIA clinical trials

Pharmacology for AURYXIA

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

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
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
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

International Patents for AURYXIA

Country	Patent Number	Estimated Expiration
Japan	2018109001
Japan	2017095477
Canada	2640763
Denmark	1978807
Taiwan	200416027
China	100386336