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Serving leading biopharmaceutical companies globally:

Covington
Merck
QuintilesIMS
Cipla
Deloitte
Daiichi Sankyo
Harvard Business School
Mallinckrodt
Cantor Fitzgerald
Chubb

Generated: November 22, 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 fifty-two patent family members in forty-seven countries and eleven supplementary protection certificates in nine countries.

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

Pharmacology for XARELTO

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for XARELTO

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;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
8,822,458Substituted 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
8,129,378Substituted 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
Germany502004006218► Subscribe
European Patent Office1845961► Subscribe
Peru09632001► Subscribe
Argentina052565► Subscribe
Hong Kong1092140► Subscribe
Turkey200201636► Subscribe
Malaysia138386► Subscribe
Hong Kong1057556► Subscribe
Slovenia1845961► Subscribe
Israel205242► 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
2008 018, C 1261606Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
1Finland► Subscribe
C0051France► SubscribePRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606/01Switzerland► SubscribeFORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
2008018Lithuania► SubscribePRODUCT NAME: RIVARAXABANUM ; REGISTER NUMBER AND DATE: EU/1/08/472/001 20080930
2008 00050Denmark► Subscribe
0370Netherlands► Subscribe
497Luxembourg► Subscribe91497, EXPIRES: 20230930
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Chinese Patent Office
US Department of Justice
McKesson
Fish and Richardson
Mallinckrodt
QuintilesIMS
Daiichi Sankyo
Covington

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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