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Last Updated: November 16, 2024

FERRIC CITRATE - Generic Drug Details


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What are the generic sources for ferric citrate and what is the scope of freedom to operate?

Ferric citrate is the generic ingredient in one branded drug marketed by Keryx Biopharms and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and twenty-two patent family members in twenty-three countries.

There are six drug master file entries for ferric citrate. One supplier is listed for this compound.

Summary for FERRIC CITRATE
Recent Clinical Trials for FERRIC CITRATE

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

SponsorPhase
Akebia TherapeuticsPhase 3
USRC Kidney ResearchPhase 3
USRC Kidney ResearchPhase 4

See all FERRIC CITRATE clinical trials

Pharmacology for FERRIC CITRATE

US Patents and Regulatory Information for FERRIC CITRATE

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FERRIC CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FERRIC CITRATE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2004074444 ⤷  Sign Up
Taiwan 200740431 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same ⤷  Sign Up
European Patent Office 2456426 FORMES POSOLOGIQUES DE CITRATE FERRIQUE (FERRIC CITRATE DOSAGE FORMS) ⤷  Sign Up
Australia 2007210096 Method of reversing, preventing, delaying or stabilizing soft tissue calcification ⤷  Sign Up
Spain 2503717 ⤷  Sign Up
Canada 2619591 COMPOSES ORGANIQUES FERRIQUES DE QUALITE PHARMACEUTIQUE AINSI QU'UTILISATION DE CEUX-CI ET PROCEDES DE FABRICATION DE CEUX-CI (PHARMACEUTICAL-GRADE FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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