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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Julphar
Fish and Richardson
Mallinckrodt
Teva
Fuji
Novartis
Cerilliant
Argus Health

Generated: February 17, 2018

DrugPatentWatch Database Preview

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.

There are thirty-three 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

US Patents and Regulatory Information for rivaroxaban

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;ORAL 022406-003 Nov 4, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,822,458 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Sign Up
7,576,111 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Sign Up
9,402,851 Process for the preparation of a solid, orally administrable pharmaceutical composition ➤ Sign Up
8,129,378 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Sign Up
8,530,505 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for rivaroxaban

Supplementary Protection Certificates for rivaroxaban

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/008 United Kingdom ➤ Sign Up SUPPLEMENTARY 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,C1261606 Lithuania ➤ Sign Up PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
0370 Netherlands ➤ Sign Up
2008 018, C 1261606 Lithuania ➤ Sign Up PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
08/030 Ireland ➤ Sign Up PRODUCT 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 00050 Denmark ➤ Sign Up PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
C0051 France ➤ Sign Up PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606/01 Switzerland ➤ Sign Up FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
2008018 Lithuania ➤ Sign Up PRODUCT NAME: RIVARAXABANUM ; REGISTER NUMBER AND DATE: EU/1/08/472/001 20080930
1 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Dow
Citi
Express Scripts
Chinese Patent Office
QuintilesIMS
US Department of Justice
Chubb
Cantor Fitzgerald

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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