DrugPatentWatch Database Preview
AURYXIA Drug Profile
Email this page to a colleague
» See Plans and PricingWhich patents cover Auryxia, 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-one 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 18, 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.
Indicators of Generic Entry
Summary for AURYXIA
| International Patents: | 131 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 7 |
| 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 |
|---|---|
| Akebia Therapeutics | Phase 1 |
| Sreedhar Mandayam | Phase 4 |
| Kaiser Permanente | Phase 4 |
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
| [2-hydroxypropane-1,2,3-tricarboxylato(3-)-kappa(3)O(1),O(2),O(3)]iron |
| 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) |
| 1185-57-5 |
| 2-hydroxy-1,2,3-propanetricarboxylic acid iron salt |
| 2-hydroxypropane-1,2,3-tricarboxylate; iron(3+) |
| 2338-05-8 |
| 28633-45-6 |
| 3522-50-7 |
| 6043-74-9 |
| 63G354M39Z |
| A832727 |
| ACM28633456 |
| AKOS015918266 |
| AKOS024284363 |
| BCP30645 |
| C6H5FeO7 |
| CCRIS 6843 |
| CHEBI:144421 |
| Citric acid, iron salt |
| Citric acid, iron(3+) salt |
| Citric acid, iron(3+) salt (1:1) |
| CTK1C2869 |
| DB-119245 |
| DB09162 |
| DTXSID0037657 |
| EINECS 222-536-6 |
| EINECS 249-117-0 |
| Fe(3+)-citrate |
| Fe(III)-citrate complex (1:1) |
| FERRIC CITRATE |
| Ferric citrate (VAN) |
| Ferric citrate [USAN] |
| ferric citrate anhydrous |
| Ferric citrate, BioReagent, suitable for cell culture |
| Ferric citrate, PharmaGrade, Manufactured under appropriate GMP controls for pharma or biopharmaceutical production. |
| FERROUS CITRATE |
| Ferrous citrate dibasic |
| ferrum citricum |
| FT-0626407 |
| FT-0627304 |
| FT-0652224 |
| FT-0696578 |
| H260 |
| Iron (III) citrate |
| Iron 2-hydroxy-1,2,3-propanetricarboxylate |
| Iron citrate |
| Iron citrate, FeC6H5O7 |
| Iron, (hydrogen citrato(3-))- |
| iron(3+) 2-hydroxypropane-1,2,3-tricarboxylate |
| iron(3+) citrate |
| iron(3+); 2-oxidanylpropane-1,2,3-tricarboxylate |
| Iron(III) citrate |
| Iron(III) citrate tribasic |
| Iron(III) citrate tribasic hydrate |
| Iron(III) citrate tribasic monohydrate, 18-20% Fe basis (T) |
| Iron(III) citrate tribasic monohydrate, puriss., 18-20% |
| Iron(III) citrate, technical grade |
| Iron(III) citrate;Iron citrate |
| Iron(III)-citrate |
| iron(iii)citrate |
| JTT 751 |
| KRX-0502 |
| KS-0000108D |
| MCULE-2140052675 |
| MFCD00013098 |
| NPFOYSMITVOQOS-UHFFFAOYSA-K |
| NSC 112227 |
| Q15628111 |
| SBB017245 |
| SCHEMBL42945 |
| ST075192 |
| 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 |
Expired US Patents for AURYXIA
| 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 AURYXIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2456426 | Start Trial |
| South Korea | 100464504 | Start Trial |
| Denmark | 1601680 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
