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Last Updated: January 18, 2020

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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

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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.

Drug patent expirations by year for AURYXIA
Drug Prices for AURYXIA

See drug prices for AURYXIA

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

SponsorPhase
Sreedhar MandayamPhase 4
Kaiser PermanentePhase 4
University of Alabama at BirminghamN/A

See all AURYXIA clinical trials

Recent Litigation for AURYXIA

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Auryxia (Ferric Citrate) Patent Litigation2019-07-31
Keryx Biopharmaceuticals, Inc. v. Lupin Ltd.2019-05-10
Keryx Biopharmaceuticals, Inc. v. Chemo Research S.L.2019-02-01

See all AURYXIA litigation

Pharmacology for AURYXIA
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

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Medtronic
Harvard Business School
Moodys
Mallinckrodt

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