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Serving leading biopharmaceutical companies globally:

Covington
Baxter
Cantor Fitzgerald
Dow
Argus Health
Citi
Queensland Health
Accenture
Harvard Business School
Cipla

Generated: December 11, 2017

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Rivaroxaban - Generic Drug Details

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What are the generic sources for rivaroxaban and what is the scope of rivaroxaban freedom to operate?

Rivaroxaban
is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are five 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 fifty-two patent family members in forty-seven countries and eleven supplementary protection certificates in nine countries.

There are thirty-one drug master file entries for rivaroxaban. Two suppliers are listed for this compound.

Pharmacology for rivaroxaban

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for rivaroxaban

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen PharmsXARELTOrivaroxabanTABLET;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► Subscribe► Subscribe► 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
8,822,458Substituted 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
8,530,505Substituted 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 Ingredient: rivaroxaban

Country Document Number Estimated Expiration
Cuba23208► Subscribe
Spain2300845► Subscribe
HungaryE025705► Subscribe
Canada2547113► Subscribe
Malaysia138386► Subscribe
Slovenia1526132► Subscribe
Cyprus1107369► Subscribe
EcuadorSP066584► Subscribe
Cyprus1116494► Subscribe
Dominican RepublicP2000000114► 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
497Luxembourg► Subscribe91497, EXPIRES: 20230930
2008 018, C 1261606Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
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
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
2008 00050Denmark► 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
0370Netherlands► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Express Scripts
Chinese Patent Office
Citi
QuintilesIMS
Chubb
Cerilliant
Healthtrust
Julphar

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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