DrugPatentWatch Database Preview
AURYXIA Drug Profile
» See Plans and Pricing
Which 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-three 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: | 133 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 67 |
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 |
Pharmacology for AURYXIA
Drug Class | Parenteral Iron Replacement Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
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 | 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 | 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 | 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 |
---|---|---|
Japan | 2018109001 | Start Trial |
Japan | 2017095477 | Start Trial |
Canada | 2640763 | Start Trial |
Denmark | 1978807 | Start Trial |
Taiwan | 200416027 | Start Trial |
China | 100386336 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |