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Last Updated: January 18, 2020

DrugPatentWatch Database Preview

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
Generic Entry Opportunity Date for 205874
Generic Entry Date for 205874*:
Constraining patent/regulatory exclusivity:
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 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 Keryx Biopharmaceuticals, Inc. 59922-631 59922-631-01 200 TABLET, 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
Regulatory Exclusivity Expiration:Nov 6, 2020
Regulatory Exclusivity Use:USE OF FERRIC CITRATE FOR THE TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH CKD NOT ON DIALYSIS
Patent:  Start TrialPatent Expiration:Jul 21, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:CONTROL OF SERUM PHOSPHORUS LEVELS
Patent:  Start TrialPatent Expiration:Feb 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:CONTROL OF SERUM PHOSPHOROUS LEVELS

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