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Last Updated: August 14, 2022

AURYXIA Drug Patent Profile


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DrugPatentWatch® 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 six 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

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Drug patent expirations by year for AURYXIA
Drug Prices for AURYXIA

See drug prices for AURYXIA

DrugPatentWatch® Estimated 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
USRC Kidney ResearchPhase 3
Akebia TherapeuticsPhase 3
USRC Kidney ResearchPhase 4

See all AURYXIA clinical trials

US Patents and Regulatory Information for AURYXIA

AURYXIA is protected by fifteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AURYXIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AURYXIA

Ferric citrate dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHORUS LEVELS

Methods for treating renal failure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

Ferric citrate dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTROL OF SERUM PHOSPHOROUS LEVELS

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

When does loss-of-exclusivity occur for AURYXIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04213819
Estimated Expiration: See Plans and Pricing

Patent: 06279333
Estimated Expiration: See Plans and Pricing

Patent: 07210090
Estimated Expiration: See Plans and Pricing

Patent: 07210096
Estimated Expiration: See Plans and Pricing

Canada

Patent: 16471
Estimated Expiration: See Plans and Pricing

Patent: 19591
Estimated Expiration: See Plans and Pricing

Patent: 40763
Estimated Expiration: See Plans and Pricing

Patent: 40974
Estimated Expiration: See Plans and Pricing

Patent: 50453
Estimated Expiration: See Plans and Pricing

China

Patent: 51056
Estimated Expiration: See Plans and Pricing

Patent: 0386336
Estimated Expiration: See Plans and Pricing

Patent: 1253186
Estimated Expiration: See Plans and Pricing

Patent: 1374416
Estimated Expiration: See Plans and Pricing

Patent: 1378658
Estimated Expiration: See Plans and Pricing

Patent: 5055446
Estimated Expiration: See Plans and Pricing

Patent: 5616397
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15602
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 01680
Estimated Expiration: See Plans and Pricing

Patent: 31689
Estimated Expiration: See Plans and Pricing

Patent: 78807
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0028
Estimated Expiration: See Plans and Pricing

Patent: 8245
Estimated Expiration: See Plans and Pricing

Patent: 0501322
Estimated Expiration: See Plans and Pricing

Patent: 0800593
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01680
Estimated Expiration: See Plans and Pricing

Patent: 31689
Estimated Expiration: See Plans and Pricing

Patent: 78807
Estimated Expiration: See Plans and Pricing

Patent: 78808
Estimated Expiration: See Plans and Pricing

Patent: 60139
Estimated Expiration: See Plans and Pricing

Patent: 94551
Estimated Expiration: See Plans and Pricing

Patent: 13511
Estimated Expiration: See Plans and Pricing

Patent: 66923
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 77580
Estimated Expiration: See Plans and Pricing

Patent: 05129
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25264
Estimated Expiration: See Plans and Pricing

Patent: 28029
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9583
Estimated Expiration: See Plans and Pricing

Patent: 2545
Estimated Expiration: See Plans and Pricing

Patent: 3099
Estimated Expiration: See Plans and Pricing

Patent: 8952
Estimated Expiration: See Plans and Pricing

Japan

Patent: 64585
Estimated Expiration: See Plans and Pricing

Patent: 67343
Estimated Expiration: See Plans and Pricing

Patent: 54226
Estimated Expiration: See Plans and Pricing

Patent: 39169
Estimated Expiration: See Plans and Pricing

Patent: 68186
Estimated Expiration: See Plans and Pricing

Patent: 32842
Estimated Expiration: See Plans and Pricing

Patent: 06518391
Estimated Expiration: See Plans and Pricing

Patent: 09504777
Estimated Expiration: See Plans and Pricing

Patent: 09525276
Estimated Expiration: See Plans and Pricing

Patent: 09525277
Estimated Expiration: See Plans and Pricing

Patent: 13177416
Estimated Expiration: See Plans and Pricing

Patent: 13227333
Estimated Expiration: See Plans and Pricing

Patent: 13231057
Estimated Expiration: See Plans and Pricing

Patent: 14240405
Estimated Expiration: See Plans and Pricing

Patent: 16026177
Estimated Expiration: See Plans and Pricing

Patent: 17036289
Estimated Expiration: See Plans and Pricing

Patent: 17095477
Estimated Expiration: See Plans and Pricing

Patent: 17125048
Estimated Expiration: See Plans and Pricing

Patent: 18109001
Estimated Expiration: See Plans and Pricing

Patent: 19194212
Estimated Expiration: See Plans and Pricing

Patent: 22020633
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2727
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05008784
Estimated Expiration: See Plans and Pricing

Patent: 4649
Estimated Expiration: See Plans and Pricing

Patent: 08002360
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1991
Estimated Expiration: See Plans and Pricing

Patent: 6743
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 01680
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 01680
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1149706
Estimated Expiration: See Plans and Pricing

Patent: 050107428
Estimated Expiration: See Plans and Pricing

Patent: 080037083
Estimated Expiration: See Plans and Pricing

Patent: 080094013
Estimated Expiration: See Plans and Pricing

Patent: 080106506
Estimated Expiration: See Plans and Pricing

Spain

Patent: 03717
Estimated Expiration: See Plans and Pricing

Patent: 39635
Estimated Expiration: See Plans and Pricing

Patent: 80127
Estimated Expiration: See Plans and Pricing

Patent: 99447
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 35218
Estimated Expiration: See Plans and Pricing

Patent: 75555
Estimated Expiration: See Plans and Pricing

Patent: 0416027
Estimated Expiration: See Plans and Pricing

Patent: 0740431
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AURYXIA around the world.

Country Patent Number Title Estimated Expiration
Norway 327148 See Plans and Pricing
Australia 5441998 See Plans and Pricing
Hungary E028029 See Plans and Pricing
Taiwan 201204349 Ferric citrate dosage forms See Plans and Pricing
Canada 2516471 COMPOSES ORGANIQUES FERRIQUES, UTILISATIONS DESDITS COMPOSESET PROCEDES DE FABRICATION ASSOCIES (FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKINGSAME) See Plans and Pricing
China 108938585 柠檬酸铁剂型 (Ferric citrate dosage forms) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Harvard Business School
Merck
McKesson
McKinsey

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 verification 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.