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Serving 500+ biopharmaceutical companies globally:

Citi
Cipla
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Federal Trade Commission
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US Army

Generated: July 26, 2017

DrugPatentWatch Database Preview

XARELTO Drug Profile

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What is the patent landscape for Xarelto, and when can generic versions of Xarelto launch?

Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-eight patent family members in forty-seven countries.

The generic ingredient in XARELTO is rivaroxaban. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

Summary for Tradename: XARELTO

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list52
Clinical Trials: see list73
Patent Applications: see list1,010
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XARELTO at DailyMed

Pharmacology for Tradename: XARELTO

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV activity for: XARELTO

Drugname Dosage Strength RLD Submissiondate
rivaroxabanTablets10 mg, 15 mg, and 20 mgXarelto7/1/2015

Non-Orange Book Patents for Tradename: XARELTO

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
9,402,851Process for the preparation of a solid, orally administrable pharmaceutical composition► Subscribe
7,576,111Substituted oxazolidinones and their use in the field of blood coagulation► Subscribe
8,530,505Substituted oxazolidinones and their use in the field of blood coagulation► Subscribe
8,822,458Substituted oxazolidinones and their use in the field of blood coagulation► Subscribe
8,129,378Substituted oxazolidinones and their use in the field of blood coagulation► 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: XARELTO

Country Document Number Estimated Expiration
Poland355665► Subscribe
European Patent Office1689370► Subscribe
Guatemala200400239► Subscribe
South Africa200204188► Subscribe
Netherlands300370► 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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Supplementary Protection Certificates for Tradename: XARELTO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/008United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/008 GRANTED TO BAYER INTELLECTUAL PROPERTY GMBH IN RESPECT OF THE PRODUCT RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6352 DATED 16 FEBRUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 OCTOBER 2023.
2008018,C1261606Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
2008018Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
2008 00050Denmark► Subscribe
1261606/01Switzerland► SubscribeFORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
QuintilesIMS
Accenture
Harvard Business School
US Army
Express Scripts
Dow
Moodys
Mallinckrodt

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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