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Serving leading biopharmaceutical companies globally:

Fuji
Moodys
Deloitte
Chubb
McKinsey
Cantor Fitzgerald
Argus Health
Accenture
Baxter
Julphar

Generated: February 25, 2018

DrugPatentWatch Database Preview

XARELTO Drug Profile

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When do Xarelto patents expire, and when can generic versions of Xarelto launch?

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 fifty-two patent family members in forty-seven countries.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-three 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 XARELTO
Drug patent expirations by year for XARELTO
Pharmacology for XARELTO
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for XARELTO

US Patents and Regulatory Information for XARELTO

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 022406-003 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 Y 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 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 022406-001 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 Y ➤ Sign Up
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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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Paragraph IV (Patent) Challenges for XARELTO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 10 mg, 15 mg, and 20 mg ➤ Subscribe 7/1/2015

Non-Orange Book US Patents for 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
7,576,111 Substituted oxazolidinones and their use in the field of blood coagulation ➤ Sign Up
8,822,458 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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Supplementary Protection Certificates for XARELTO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1261606/01 Switzerland ➤ Sign Up FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
C0051 France ➤ Sign Up PRODUCT NAME: RIVAROXABAN; 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
0370 Netherlands ➤ Sign Up
1 Finland ➤ Sign Up
2008018 Lithuania ➤ Sign Up PRODUCT NAME: RIVARAXABANUM ; REGISTER NUMBER AND DATE: EU/1/08/472/001 20080930
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.
2008 018, C 1261606 Lithuania ➤ Sign Up PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
2008018,C1261606 Lithuania ➤ Sign Up PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Deloitte
QuintilesIMS
Medtronic
Covington
Boehringer Ingelheim
Farmers Insurance
Argus Health
Merck

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