Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Mallinckrodt
US Army
AstraZeneca
Fish and Richardson
Merck
Covington
Citi
Dow

Generated: August 21, 2017

DrugPatentWatch Database Preview

Rivaroxaban - Generic Drug Details

« Back to Dashboard

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 thirty-eight patent family members in forty-seven countries.

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

Summary for Generic Name: rivaroxaban

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list29
Suppliers / Packagers: see list2
Bulk Api Vendors: see list53
Clinical Trials: see list176
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 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;ORAL022406-003Nov 4, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-001Jul 1, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen Pharms
XARELTO
rivaroxaban
TABLET;ORAL022406-002Nov 4, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,530,505Substituted 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
8,822,458Substituted oxazolidinones and their use in the field of blood coagulation► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: rivaroxaban

Country Document Number Estimated Expiration
Japan2003519141► Subscribe
Cyprus1116494► Subscribe
European Patent Office1526132► Subscribe
Cuba23208► Subscribe
Hong Kong1103235► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: RIVAROXABAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008018,C1261606Lithuania► SubscribePRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
C0051France► SubscribePRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
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.
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKinsey
Citi
Mallinckrodt
UBS
Covington
AstraZeneca
Colorcon
McKesson
Federal Trade Commission
Deloitte

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot