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Last Updated: September 27, 2022

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 two NDAs. There are five patents protecting this drug and three 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 December 20, 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-six 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 are two tentative approvals 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 Dates for XARELTO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for XARELTO*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
Dosage:
FOR SUSPENSION;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
Laval UniversityPhase 2
Chiayi Christian HospitalN/A
University of CincinnatiPhase 2/Phase 3

See all XARELTO clinical trials

Pharmacology for XARELTO
Drug ClassFactor Xa Inhibitor
Mechanism of Action Factor Xa Inhibitors
Paragraph IV (Patent) Challenges for XARELTO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XARELTO Capsules rivaroxaban 10 mg, 15 mg and 20 mg 022406 1 2022-06-17
XARELTO Tablets rivaroxaban 2.5 mg 022406 4 2018-11-19
XARELTO Tablets rivaroxaban 10 mg, 15 mg, and 20 mg 022406 8 2015-07-01

US Patents and Regulatory Information for XARELTO

XARELTO is protected by five US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XARELTO is See Plans and Pricing.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XARELTO

Reducing the risk of cardiovascular events
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted oxazolidinones and their use in the field of blood coagulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted oxazolidinones and their use in the field of blood coagulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid, orally administrable pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prevention and treatment of thromboembolic disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting XARELTO

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
Exclusivity Expiration: See Plans and Pricing

INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban FOR SUSPENSION;ORAL 215859-001 Dec 20, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022406-003 Nov 4, 2011 See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-003 Nov 4, 2011 See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-002 Nov 4, 2011 See Plans and Pricing See Plans and Pricing
Janssen Pharms XARELTO rivaroxaban TABLET;ORAL 022406-004 Oct 11, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for XARELTO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Rivaroxaban Accord rivaroxaban EMEA/H/C/005279
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients).AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.AdultsPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Authorised yes no no 2020-11-16
Mylan Ireland Limited Rivaroxaban Mylan rivaroxaban EMEA/H/C/005600
Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. ------Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.-------Adults Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 
Authorised yes no no 2021-11-12
Bayer AG Xarelto rivaroxaban EMEA/H/C/000944
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.AdultsPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Authorised no no no 2008-09-30
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for XARELTO

When does loss-of-exclusivity occur for XARELTO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7844
Estimated Expiration: See Plans and Pricing

Patent: 4840
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04305226
Estimated Expiration: See Plans and Pricing

Austria

Patent: 5782
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0416404
Estimated Expiration: See Plans and Pricing

Canada

Patent: 47113
Estimated Expiration: See Plans and Pricing

China

Patent: 86120
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 90540
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0080150
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 551
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 07369
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 89370
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066584
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89370
Estimated Expiration: See Plans and Pricing

Germany

Patent: 355461
Estimated Expiration: See Plans and Pricing

Patent: 2004006218
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0400239
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 04000490
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99518
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5860
Estimated Expiration: See Plans and Pricing

Japan

Patent: 52423
Estimated Expiration: See Plans and Pricing

Patent: 07512274
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8386
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 178
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7466
Estimated Expiration: See Plans and Pricing

Norway

Patent: 0156
Estimated Expiration: See Plans and Pricing

Patent: 062942
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050666
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89370
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 89370
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 79036
Estimated Expiration: See Plans and Pricing

Patent: 93850
Estimated Expiration: See Plans and Pricing

Patent: 06122599
Estimated Expiration: See Plans and Pricing

Patent: 09127302
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89370
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0604166
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1151117
Estimated Expiration: See Plans and Pricing

Patent: 060117330
Estimated Expiration: See Plans and Pricing

Spain

Patent: 00845
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 56702
Estimated Expiration: See Plans and Pricing

Patent: 0529859
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 693
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XARELTO around the world.

Country Patent Number Title Estimated Expiration
Morocco 25646 See Plans and Pricing
Canada 2547113 PROCEDE POUR PRODUIRE UNE COMPOSITION PHARMACEUTIQUE SOLIDE A APPLICATION ORALE (METHOD FOR THE PRODUCTION OF A SOLID, ORALLY APPLICABLE PHARMACEUTICAL COMPOSITION) See Plans and Pricing
Portugal 1526132 See Plans and Pricing
Malaysia 138386 PROCESS FOR THE PREPARATION OF A SOLID, ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITION See Plans and Pricing
Cyprus 1115117 See Plans and Pricing
Germany 122009000014 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XARELTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261606 PA2008018 Lithuania See Plans and Pricing PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
1261606 48/2008 Austria See Plans and Pricing PRODUCT NAME: RIVAROXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/08/472/001 - EU/1/08/472/008 20080930
1261606 08C0051 France See Plans and Pricing PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606 C 2008 019 Romania See Plans and Pricing 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 91497 Luxembourg See Plans and Pricing 91497, EXPIRES: 20230930
1261606 PA2008018,C1261606 Lithuania See Plans and Pricing PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.