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.
Summary for ferric citrate
International Patents: | 121 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 34 |
Patent Applications: | 3,590 |
Formulation / Manufacturing: | see details |
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 |
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
Sponsor | Phase |
---|---|
USRC Kidney Research | Phase 3 |
Akebia Therapeutics | Phase 3 |
USRC Kidney Research | 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 | ⤷ 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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