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 four patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and fifty-six 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. Four 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 February 28, 2025. This may change due to patent challenges or generic licensing.
Annual sales in 2021 were $6.3bn, indicating a strong incentive for generic entry (peak sales were $7.2bn in 2020).
There have been thirty-one 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 five tentative approvals for the generic drug (rivaroxaban), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for XARELTO
| International Patents: | 156 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 124 |
| Patent Applications: | 3,793 |
| Drug Prices: | Drug price information for XARELTO |
| Drug Sales Revenues: | Drug sales revenues for XARELTO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XARELTO |
| What excipients (inactive ingredients) are in XARELTO? | XARELTO excipients list |
| DailyMed Link: | XARELTO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XARELTO
*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
| Sponsor | Phase |
|---|---|
| Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network | Phase 2/Phase 3 |
| Ottawa Hospital Research Institute | Phase 2/Phase 3 |
| Canadian Institutes of Health Research (CIHR) | Phase 2/Phase 3 |
Pharmacology for XARELTO
| Drug Class | Factor 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 four US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XARELTO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted oxazolidinones and their use in the field of blood coagulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid, orally administrable pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Prevention and treatment of thromboembolic disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting XARELTO
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | FOR SUSPENSION;ORAL | 215859-001 | Dec 20, 2021 | 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 | ||||
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | 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 | 022406-003 | Nov 4, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | 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 |
Expired US Patents for XARELTO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-002 | Nov 4, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-003 | Nov 4, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-003 | Nov 4, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-002 | Nov 4, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >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 Viatris (previously 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
See the table below for patents covering XARELTO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 205242 | SUBSTITUTED OXAZOLIDINONES, PROCESSES FOR THEIR PREPARATION, COMPOSITIONS COMPRISING THEM AND USES THEREOF FOR THE MANUFACTURE OF MEDICAMENTS FOR THE TREATMENT OF DISEASES | ⤷ Sign Up |
| Taiwan | I226330 | ⤷ Sign Up | |
| Germany | 50009607 | ⤷ Sign Up | |
| Cuba | 23208 | OXAZOLIDINONAS SUSTITUIDAS Y SU USO EN EL CAMPO DE LA COAGULACION SANGUINEA | ⤷ Sign Up |
| Argentina | 104840 | COMPOSICIÓN FARMACÉUTICA SÓLIDA ADMINISTRABLE ORALMENTE, USO Y PROCEDIMIENTO PARA LA PROFILAXIS Y/O TRATAMIENTO DE ENFERMEDADES TROMBOEMBÓLICAS | ⤷ Sign Up |
| El Salvador | 2002000245 | OXAZOLIDINONAS SUBSTITUIDAS Y SU USO REF. LEA 34122-SV | ⤷ Sign Up |
| Japan | 4852423 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XARELTO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261606 | SPC/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. |
| 1261606 | CA 2008 00050 | Denmark | ⤷ Sign Up | PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS |
| 1261606 | 361 | Finland | ⤷ Sign Up | |
| 1261606 | C 2008 019 | Romania | ⤷ Sign Up | 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,C1261606 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930 |
| 1261606 | PA 2008 018, C 1261606 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930 |
| 1261606 | C01261606/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE |
| >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.
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