Details for New Drug Application (NDA): 205874

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NDA 205874 describes AURYXIA, which is a drug marketed by Keryx Biopharms and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the AURYXIA profile page.

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.

Summary for 205874

Tradename:	AURYXIA
Applicant:	Keryx Biopharms
Ingredient:	ferric citrate
Patents:	15
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205874

Generic Entry Date for 205874^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 NDA: 205874

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 205874

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AURYXIA	ferric citrate	TABLET;ORAL	205874	NDA	Akebia Therapeutics, Inc.	59922-631	59922-631-01	200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 210MG IRON
Approval Date:	Sep 5, 2014	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 21, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	CONTROL OF SERUM PHOSPHORUS LEVELS
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 3, 2022	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	CONTROL OF SERUM PHOSPHOROUS LEVELS
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 18, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 205874

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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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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