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AURYXIA Drug Profile
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When do Auryxia patents expire, and when can generic versions of Auryxia launch?
Auryxia is a drug marketed by Keryx Biopharms and is included in one NDA. There are fifteen patents protecting this drug.
This drug has one hundred and thirty patent family members in twenty-six countries.
The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric citrate profile page.
US ANDA Litigation and Generic Entry Outlook for Auryxia
Auryxia was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 18th, 2024. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for AURYXIA
| International Patents: | 130 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 6 |
| Patent Applications: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AURYXIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AURYXIA |
| DailyMed Link: | AURYXIA at DailyMed |
Generic Entry Opportunity Date for AURYXIA
Generic Entry Date for AURYXIA*:
Constraining patent/regulatory exclusivity:
NDA:
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 AURYXIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sreedhar Mandayam | Phase 4 |
| Kaiser Permanente | Phase 4 |
| University of Alabama at Birmingham | N/A |
Recent Litigation for AURYXIA
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 AURYXIA
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Synonyms for AURYXIA
| 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 |
| 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 |
| 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 AURYXIA
| 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 | 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 AURYXIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101378658 | Start Trial |
| South Korea | 20080106506 | Start Trial |
| Australia | 5441998 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
