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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
UBS
Boehringer Ingelheim
Citi
AstraZeneca
Covington
Daiichi Sankyo
Mallinckrodt
Novartis

Generated: December 10, 2017

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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 fourteen patents protecting this drug.

This drug has one hundred and eighteen patent family members in twenty-six countries.

The generic ingredient in AURYXIA is ferric citrate. There are fourteen 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 Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Keryx BiopharmsAURYXIAferric citrateTABLET;ORAL205874-001Sep 5, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Non-Orange Book Patents for Tradename: AURYXIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,750,715Method of reversing, preventing, delaying or stabilizing soft tissue calcification► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AURYXIA

Country Document Number Estimated Expiration
Japan2007217429► Subscribe
Taiwan201544102► Subscribe
World Intellectual Property Organization (WIPO)9826776► Subscribe
World Intellectual Property Organization (WIPO)2007022435► Subscribe
New Zealand541991► Subscribe
European Patent Office0959878► Subscribe
South Korea20120046753► Subscribe
China1751056► Subscribe
Canada2516471► Subscribe
World Intellectual Property Organization (WIPO)2004074444► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Argus Health
Novartis
Moodys
Chubb
Colorcon
Fish and Richardson
Merck
US Army
QuintilesIMS
Chinese Patent Office

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.

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