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Last Updated: June 27, 2022

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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric citrate has one hundred and thirty-six patent family members in twenty-six countries.

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

Recent Clinical Trials for FERRIC CITRATE

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

SponsorPhase
USRC Kidney ResearchPhase 3
Akebia TherapeuticsPhase 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FERRIC CITRATE

Country Patent Number Title Estimated Expiration
New Zealand 566743 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same See Plans and Pricing
Cyprus 1115602 See Plans and Pricing
Japan 2017036289 慢性腎疾患の治療法 (METHOD OF TREATING CHRONIC KIDNEY DISEASE) See Plans and Pricing
Denmark 1978807 See Plans and Pricing
Ukraine 107803 ЛІКАРСЬКА ФОРМА ЦИТРАТУ ЗАЛІЗА(ІІІ) (DOSAGE FORM OF IRON CITRATE (iii)) See Plans and Pricing
China 100386336 See Plans and Pricing
South Korea 20080094013 METHOD OF REVERSING, PREVENTING, DELAYING OR STABILIZING SOFT TISSUE CALCIFICATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
McKesson
Merck
Harvard Business School
Colorcon

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