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-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
International Patents: | 122 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 34 |
Patent Applications: | 2,751 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ferric citrate |
What excipients (inactive ingredients) are in ferric citrate? | ferric citrate excipients list |
DailyMed Link: | ferric citrate at DailyMed |
Recent Clinical Trials for ferric citrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Akebia Therapeutics | Phase 3 |
USRC Kidney Research | Phase 3 |
Akebia Therapeutics Inc. | Phase 4 |
Pharmacology for ferric citrate
Drug Class | Parenteral Iron Replacement Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ 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 | |||
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 | ⤷ 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 | ⤷ 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 |
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 |
---|---|---|---|
Brazil | 112012001372 | comprimido, e, métodos para preparar um comprimido e para a profilaxia ou tratamento de hiperfosfatemia. | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007089577 | ⤷ Sign Up | |
Eurasian Patent Organization | 200501322 | ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ ЖЕЛЕЗА (III), ИХ ПРИМЕНЕНИЕ И СПОСОБЫ ПОЛУЧЕНИЯ УКАЗАННЫХ СОЕДИНЕНИЙ | ⤷ Sign Up |
Taiwan | 201711676 | Ferric citrate dosage forms | ⤷ Sign Up |
Japan | 2017125048 | 軟組織石灰化の回復、予防、遅延または安定化方法 (METHOD OF REVERSING, PREVENTING, DELAYING OR STABILIZING SOFT TISSUE CALCIFICATION) | ⤷ Sign Up |
Australia | 2004213819 | Ferric organic compounds, uses thereof and methods of making same | ⤷ Sign Up |
Taiwan | I670086 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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