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Ferric citrate - Generic Drug Details
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 patent family members in twenty-six countries.
There are twenty drug master file entries for ferric citrate. One supplier is listed for this compound.
Summary for ferric citrate
| International Patents: | 130 |
| US Patents: | 15 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 25 |
| Patent Applications: | 3 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ferric citrate |
| DailyMed Link: | ferric citrate at DailyMed |
Recent Clinical Trials for ferric citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rockwell Medical Technologies, Inc. | Phase 3 |
| Shandong Weigao Panion Pharmaceutical Co. Ltd. | Phase 3 |
| Sreedhar Mandayam | Phase 4 |
Recent Litigation for ferric citrate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| In re: Auryxia (Ferric Citrate) Patent Litigation | 2019-07-31 |
| Keryx Biopharmaceuticals, Inc. v. Lupin Ltd. | 2019-05-10 |
| Keryx Biopharmaceuticals, Inc. v. Chemo Research S.L. | 2019-02-01 |
Pharmacology for ferric citrate
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Synonyms for ferric citrate
| 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron salt |
| 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron salt (1:?) |
| 1,2,3-propanetricarboxylic acid, 2-hydroxy-, iron(2+) salt (2:3) |
| 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron(3+) salt |
| 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, iron(3+) salt (1:1) |
| 11084-12-1 |
| 1185-57-5 |
| 12386-83-3 |
| 12549-57-4 |
| 17217-76-4 (trihydrate) |
| 2-hydroxy-1,2,3-propanetricarboxylic acid iron salt |
| 2-hydroxypropane-1,2,3-tricarboxylate; iron(3+) |
| 23087-37-8 |
| 2338-05-8 |
| 2338-05-8 (unspecified iron salt) |
| 28633-45-6 |
| 28633-45-6 (unspecified iron(+3) salt) |
| 3522-50-7 |
| 3522-50-7 (Parent) |
| 47516-89-2 |
| 57979-58-5 (dihydrate) |
| 6043-74-9 |
| 62709-48-2 |
| 63G354M39Z |
| 7705-15-9 |
| A832727 |
| AC1L1UYI |
| ACM28633456 |
| AKOS015918266 |
| AN-19905 |
| Auryxia |
| C6H5FeO7 |
| CCRIS 6843 |
| Citric acid, iron salt |
| Citric acid, iron(3+) salt |
| Citric acid, iron(3+) salt (1:1) |
| CTK1C2869 |
| DB09162 |
| DTXSID0037657 |
| EINECS 222-536-6 |
| EINECS 249-117-0 |
| Fe(III)-citrate complex (1:1) |
| Ferric citrate (VAN) |
| Ferric citrate [USAN] |
| FERROUS CITRATE |
| ferrum citricum |
| FT-0626407 |
| FT-0627304 |
| FT-0652224 |
| H260 |
| I14-60931 |
| I14-8077 |
| Iron (III) citrate |
| Iron 2-hydroxy-1,2,3-propanetricarboxylate |
| Iron citrate |
| Iron citrate, FeC6H5O7 |
| Iron, (hydrogen citrato(3-))- |
| iron(3+) citrate |
| iron(3+); 2-oxidanylpropane-1,2,3-tricarboxylate |
| Iron(III) citrate |
| Iron(III) citrate tribasic |
| Iron(III)-citrate |
| JTT 751 |
| KRX-0502 |
| KS-0000108D |
| MCULE-2140052675 |
| NPFOYSMITVOQOS-UHFFFAOYSA-K |
| NSC 112227 |
| SCHEMBL42945 |
| TR-037246 |
| TRA0022730 |
| UNII-63G354M39Z |
| Zerenex |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Keryx Biopharms | AURYXIA | ferric citrate | TABLET;ORAL | 205874-001 | Sep 5, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ferric citrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 189583 | Start Trial |
| Taiwan | I510236 | Start Trial |
| Japan | 2007217429 | Start Trial |
| China | 108938585 | Start Trial |
| Japan | 2017125048 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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