Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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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.

Recent Clinical Trials for ferric citrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shandong Weigao Panion Pharmaceutical Co. Ltd.Phase 3
Sreedhar MandayamPhase 4
Kaiser PermanentePhase 4

See all ferric citrate clinical trials

Recent Litigation for ferric citrate

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 ferric citrate litigation

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

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Johnson and Johnson
Harvard Business School
Express Scripts
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.