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Last Updated: October 22, 2019

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. 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. 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.

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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