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Last Updated: September 24, 2021

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XARELTO Drug Patent 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 four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-seven patent family members in forty-seven countries.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

DrugPatentWatch® Generic Entry Outlook for Xarelto

Xarelto was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2024. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $6.5bn, indicating a strong incentive for generic entry.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (rivaroxaban), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XARELTO
Drug Prices for XARELTO

See drug prices for XARELTO

Drug Sales Revenue Trends for XARELTO

See drug sales revenues for XARELTO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XARELTO
Generic Entry Date for XARELTO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XARELTO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital Inselspital, BernePhase 1
Centre Hospitalier Universitaire VaudoisPhase 1
University of KarachiPhase 1

See all XARELTO clinical trials

Pharmacology for XARELTO
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Paragraph IV (Patent) Challenges for XARELTO
Tradename Dosage Ingredient NDA Submissiondate
XARELTO TABLET;ORAL rivaroxaban 022406 2018-11-19
XARELTO TABLET;ORAL rivaroxaban 022406 2015-07-01

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 022406-004 Oct 11, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for XARELTO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-001 Jul 1, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for XARELTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 PA 2008 018, C 1261606 Lithuania ⤷  Free Forever Trial PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
1261606 C01261606/01 Switzerland ⤷  Free Forever Trial FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
1261606 C 2008 019 Romania ⤷  Free Forever Trial PRODUCT NAME: 5-CLORO-N-({(5S)-2-OXO-3-[4-(3-OXO-4-MORFOLINIL)FENIL]-1,3-OXAZOLIDIN-5-IL}-METIL)-2TIOFENCARBOXAMIDA - RIVAROXABAN; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/472/001, RO EU/1/08/472/002, RO EU/1/08/472/003, RO EU/1/08/472/004, RO EU/1/08/472/005, RO EU/1/08/472/006, RO EU/1/08/472/007, RO EU/1/08/472/008; DATE OF NATIONAL AUTHORISATION: 20080930; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/472/001, EMEA EU/1/08/472/002, EMEA EU/1/08/472/003, EMEA EU/1/08/472/004, EMEA EU/1/08/472/005, EMEA EU/1/08/472/006, EMEA EU/1/08/472/007, EMEA EU/1/08/472/008; DATE OF FIRST AUTHORISATION IN EEA: 20080930
1261606 PA2008018 Lithuania ⤷  Free Forever Trial PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
1261606 300370 Netherlands ⤷  Free Forever Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
AstraZeneca
McKesson
Boehringer Ingelheim
Colorcon

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