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Last Updated: October 2, 2023

Ferric citrate - Generic Drug Details


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What are the generic drug 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-one patent family members in twenty-three countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ferric citrate
Generic Entry Date for ferric citrate*:
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.

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Portugal 1601680 ⤷  Try a Trial
Eurasian Patent Organization 200800593 ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ ТРЕХВАЛЕНТНОГО ЖЕЛЕЗА ФАРМАЦЕВТИЧЕСКОГО КАЧЕСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Try a Trial
Israel 189583 תרכובות פרמצבטיות המכילות ברזל ציטרט, ושימושן להכנת תרופות להפחתת רמות פוספט בסרום לטיפול או הקלה של הפרעות הקשורות לסידן (Pharmaceutical compositions comprising ferric citrate and uses thereof for the preparation of medicaments for reducing serum phosphate levels and treating or ameliorating calcium-associated disorders) ⤷  Try a Trial
Australia 2006279333 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same ⤷  Try a Trial
Japan 2016026177 慢性腎疾患の治療法 (METHOD OF TREATING CHRONIC KIDNEY DISEASE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
McKinsey
Moodys
Boehringer Ingelheim
Medtronic

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