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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 twenty-eight patent family members in twenty-six countries.
There are twenty drug master file entries for ferric citrate.
Summary for ferric citrate
| International Patents: | 128 |
| US Patents: | 15 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 20 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 24 |
| 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 |
|---|---|
| Shandong Weigao Panion Pharmaceutical Co. Ltd. | Phase 3 |
| Sreedhar Mandayam | Phase 4 |
| Kaiser Permanente | 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 |
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 | 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 | 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 |
International Patents for ferric citrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101149706 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9826776 | Start Trial |
| European Patent Office | 2360139 | Start Trial |
| New Zealand | 541991 | Start Trial |
| Japan | 6239169 | Start Trial |
| China | 102573807 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
