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XARELTO Drug Profile

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Which patents cover Xarelto, and what substitute generic drugs are available?

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-six patent family members in forty-seven countries.

The generic ingredient in XARELTO is rivaroxaban. There are twenty-five 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 list44
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes7,592,339► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo9,539,218► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-003Nov 4, 2011RXYesYes7,585,860► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo7,157,456► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo7,585,860► SubscribeY ► 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
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
8,129,378Substituted 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
9,402,851Process for the preparation of a solid, orally administrable pharmaceutical composition► 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
Australia2006208613► Subscribe
Uruguay34152► Subscribe
Hong Kong1057556► Subscribe
Japan2003519141► Subscribe
Turkey200401314► 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
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
2008018,C1261606Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
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.
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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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