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Rivaroxaban - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for rivaroxaban?

Rivaroxaban is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rivaroxaban has one hundred and thirty-six patent family members in forty-seven countries.

There are twenty-five drug master file entries for rivaroxaban. Two suppliers are listed for this compound.

Summary for Generic Name: rivaroxaban

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list25
Suppliers / Packagers: see list2
Bulk Api Vendors: see list53
Clinical Trials: see list58
Patent Applications: see list1,584
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rivaroxaban at DailyMed

Pharmacology for Ingredient: rivaroxaban

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;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo9,415,053► SubscribeY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo7,157,456► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo9,539,218► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo9,415,053► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: rivaroxaban

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
9,402,851Process for the preparation of a solid, orally administrable pharmaceutical composition► Subscribe
8,129,378Substituted 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
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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 Ingredient: rivaroxaban

Country Document Number Estimated Expiration
Russian Federation2009127302► Subscribe
China1262551► Subscribe
European Patent Office1261606► Subscribe
Norway20062942► Subscribe
Colombia5251440► 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: RIVAROXABAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
08/030Ireland► SubscribePRODUCT NAME: RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS.; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1Finland► Subscribe
497Luxembourg► Subscribe91497, EXPIRES: 20230930
1261606/01Switzerland► SubscribeFORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
C0051France► SubscribePRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
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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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