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Last Updated: April 24, 2024

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 fourteen 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:14
Formulation / Manufacturing:see details
Pharmacology for NDA: 205874
Mechanism of ActionPhosphate 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:RXDosage:TABLET;ORALStrengthEQ 210MG IRON
Approval Date:Sep 5, 2014TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 21, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:CONTROL OF SERUM PHOSPHORUS LEVELS
Patent:⤷  Try a TrialPatent Expiration:Feb 18, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Apr 21, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:CONTROL OF SERUM PHOSPHOROUS LEVELS

Expired US Patents for NDA 205874

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
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Try a Trial ⤷  Try a Trial
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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