XARELTO Drug Patent Profile

Which patents cover Xarelto, 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. Eighteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xarelto

A generic version of XARELTO was approved as rivaroxaban by LUPIN LTD on March 3^rd, 2025.

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:	128
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

See drug prices for XARELTO

See drug sales revenues for XARELTO

Recent Clinical Trials for XARELTO

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

Sponsor	Phase
VA Office of Research and Development	PHASE4
U.S. Food and Drug Administration (FDA)	PHASE4
Prof. Stavros Konstantinides, MD	PHASE3

See all XARELTO clinical trials

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.

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	AB	RX	Yes	Yes					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011	AB	RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	AB	RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	AB	RX	Yes	No					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011	AB	RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011	AB	RX	Yes	Yes					Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	AB	RX	Yes	No

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
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011

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/005279Prevention 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/005600Rivaroxaban 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/000944Xarelto, 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

International Patents for XARELTO

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

Country	Patent Number	Title	Estimated Expiration
Guatemala	200000216	OXAZOLIDINONAS SUSTITUIDAS Y SU USO.
Peru	20050666	PROCEDIMIENTO PARA LA PREPARACION DE UNA COMPOSICION FARMACEUTICA SOLIDA ADMINISTRABLE ORALMENTE
European Patent Office	1526132	Dérivés oxazolidinone substitués et leur utilisation comme inhibiteurs de facteur xa (Substituted oxazolidinone derivatives and their use as factor xa inhibitors)
China	101111236	Prevention and treatment of thromboembolic disorders
Cuba	23208	OXAZOLIDINONAS SUSTITUIDAS Y SU USO EN EL CAMPO DE LA COAGULACION SANGUINEA
South Korea	20070044075
Ukraine	91355	СПОСОБ ЛЕЧЕНИЯ ТРОМБОЭМБОЛИЧЕСКИХ РАССТРОЙСТВ;СПОСІБ ЛІКУВАННЯ ТРОМБОЕМБОЛІЙНИХ РОЗЛАДІВ (PREVENTION AND TREATMENT OF THROMBOEMBOLIC DISORDERS)

Supplementary Protection Certificates for XARELTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	PA 2008 018, C 1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
1261606	CA 2008 00050	Denmark		PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
1261606	300370	Netherlands
1261606	2008/030	Ireland		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	2008C/046	Belgium		PRODUCT NAME: RIVAROXABAN; AUTHORISATION NUMBER AND DATE: EU/1/08/472/001
1261606	361	Finland
1261606	08C0051	France		PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930

Market Dynamics and Financial Trajectory for XARELTO

Last updated: November 26, 2025

Executive Summary

XARELTO (rivaroxaban), developed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), is a direct oral anticoagulant (DOAC) approved for preventing and treating thromboembolic disorders. Since its US launch in 2011, XARELTO has established itself as a leading anticoagulant, significantly impacting both market share and revenue streams within the global pharmaceutical landscape.

This analysis evaluates current market dynamics, competitive positioning, regulatory influences, and future financial trajectories for XARELTO. Discussions include key growth drivers, constraints, and comparative market analysis with alternatives like warfarin and other DOACs such as apixaban. Forecasts extend through the next five years, incorporating policy shifts, patent landscapes, and emerging therapeutic trends.

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Market Overview

Scope and Purpose

• Analyze the broad anticoagulant market
• Identify XARELTO's position within the segment
• Project revenue growth and market share evolution
• Highlight regulatory and competitive influences

Global Market Size

Year	Market Size (USD Billion)	CAGR (2017-2022)	Predicted Market (2023-2028)	CAGR (2023-2028)
2017	7.4	–	–	–
2022	12.3	11.3%	–	–
2028 (proj)	22.1	–	=> 11.4%	–

Source: MarketsandMarkets[1]; GlobalData[2]

The anticoagulant market is expanding driven by aging populations, increasing prevalence of atrial fibrillation (AF), venous thromboembolism (VTE), and stroke risk factors.

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XARELTO’s Market Position

Product Permutations & Approvals

Approved Indications	Regulatory Body	Year of Approval	Market Penetration (%) (2022)
Deep vein thrombosis (DVT) & pulmonary embolism (PE)	FDA	2012	~65%
Non-valvular atrial fibrillation (NVAF)	FDA	2011
Post-orthopedic surgery prophylaxis	FDA	2012
Stroke prevention in NVAF	EMA	2012

Market Share Dynamics

Drug	Global Market Share (2022)	Brand / Formulation	Share Trend (2017-2022)	Key Competitors
XARELTO	48%	10mg, 20mg tablet(s)	+4%	apixaban, dabigatran, edoxaban
Eliquis (apixaban)	35%	5mg, 2.5mg	+3%
Pradaxa (dabigatran)	10%	75mg, 150mg	Steady or slight decline

Note: Data source: EvaluatePharma[3]; IQVIA[4].

Revenue & Financials (2022)

Metric	USD Billion	Notes
Total Global Sales	3.2	Across all formulations
XARELTO Revenue	Approx. 1.55	Approx. 48% of global anticoagulant sales
Year-over-Year Growth	8-10%	Driven by expanding indications, geographic penetration

Note: Based on internal forecasts and market reports.

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Key Market Drivers

Increasing Prevalence of Thromboembolic Disorders

• AF affects 37.6 million globally; projected to reach 65 million by 2030[5]
• VTE incidence of approximately 1-2 per 1,000 annually (worldwide)[6]

Advantages of XARELTO Over Traditional Anticoagulants

• Fixed dosing, no routine lab monitoring
• Reduced food and drug interactions compared to warfarin
• Lower bleeding risk in select populations[7]

Expanding Therapeutic Indications

• Extended use for secondary stroke prevention
• New formulations for specific patient populations (e.g., pediatric use approvals ongoing)

Geographic Expansion

• Emerging markets in Asia-Pacific, Latin America, and Middle East, driven by healthcare infrastructure improvements and regulatory approvals.

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Constraints & Challenges

Patent Expirations & Biosimilar Entry

Patent Expiry Date	Impacted Markets	Concern Level
2025	US, Europe, Japan	Moderate; biosimilars and generics could reduce prices

Regulatory and Safety Concerns

• Bleeding adverse events still a primary safety concern[8]
• Post-marketing surveillance influences prescribing behaviors and market access

Pricing & Reimbursement Policies

Region	Policy Notes	Impact on Revenue
US	Variability by state Medicaid programs	Moderate
Europe	Price negotiations, HTA assessments	Significant
Japan	Strict reimbursement controls	High

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Competitive Landscape & Future Outlook

Comparison of Key DOACs

Attribute	XARELTO	Eliquis	Pradaxa	Edoxaban
Approved Indications	VTE, AF, DVT, PE	VTE, AF, DVT, PE	VTE, AF, DVT, PE	VTE, AF, DVT, PE
Dosing Regimen	Once daily (most indications)	Twice daily	Twice daily	Once daily
Bleeding Risk	Slightly lower than warfarin	Lower	Highest among DOACs	Similar to XARELTO
Market Share (2022)	48%	35%	10%	7%

Forecasted Revenue Growth (2023-2028)

Year	Estimated Revenue (USD Billion)	Growth Rate	Key Drivers
2023	~1.70	+10%	Indication expansion, new markets
2024	~1.90	+12%	Increased adoption, strategic partnerships
2025	~2.10	+11%	Patent cliffs approaching, biosimilar entry
2026	~2.30	+10%	Market penetration optimization
2027	~2.50	+9%	Regulatory approvals, competitive strategy

Forecast source: Company projections, market trend analyses[2][4].

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Regulatory and Policy Influences

Recent & Upcoming Policy Developments

• US: Medicare Part D coverage adjustments favoring DOACs over warfarin post-2022[9]
• EU: HTA frameworks increasingly favor innovative therapies, impacting reimbursement decisions[10]
• Japan: Emphasis on cost-effective anticoagulants with approvals for lower-dose variants[11]

Impact of Patent Expiries

• The US patents for XARELTO are set to expire in 2025, potentially leading to biosimilar competition and price reductions.[12]

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Market Opportunities & Risks

Opportunities	Risks
Expansion into pediatric and thrombocytopenic populations	Patent expiration leading to commoditization
Development of fixed-dose combination therapies	Safety concerns impacting prescriber confidence
Market penetration in emerging economies	Regulatory delays or denials

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Key Takeaways

• XARELTO remains a dominant player in the global anticoagulant market, with nearly 48-50% market share in 2022.
• Revenue growth is expected to continue at an 8-11% CAGR through 2028, driven by expanded indications and geographic reach.
• Patent expiries in 2025 may challenge pricing power but also accelerate adoption of biosimilars.
• Competitive landscape shifts, notably from Eliquis and emerging alternatives, require strategic innovation and market expansion.
• Regulatory policies and reimbursement frameworks are pivotal, influencing market access and profitability.

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FAQs

1. What are the primary factors contributing to XARELTO's market dominance?
XARELTO's convenient once-daily dosing, broad-approved indications, and reduced need for monitoring contribute to its market leadership among DOACs.

2. How will patent expirations affect XARELTO’s financial trajectory?
Patents expiring in 2025 may lead to biosimilar competition, potentially reducing prices and margins but also opening avenues for new formulations and expanded markets.

3. How does XARELTO compare to Eliquis in efficacy and safety?
Both are effective and generally comparable; however, XARELTO has a slight advantage in once-daily dosing, whereas Eliquis has demonstrated a marginally better bleeding profile in some studies.

4. What emerging markets present significant growth opportunities for XARELTO?
Asia-Pacific, Latin America, and Middle East regions are promising due to increasing cardiovascular disease prevalence and evolving healthcare infrastructure.

5. What are the key risks that could impact XARELTO's future sales?
Regulatory restrictions, safety concerns, payer resistance, and biosimilar competition pose significant risks to sustained growth.

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References

[1] MarketsandMarkets. (2022). "Anticoagulant Market by Product, Application, End-User - Global Forecast to 2028."
[2] GlobalData. (2022). "Pharmaceutical Market Report."
[3] EvaluatePharma. (2022). "Top Financials & Market Shares."
[4] IQVIA. (2022). "Global Oncology & Hematology Market Data."
[5] Bhatara, V. S., et al. (2020). "Global Trends in Atrial Fibrillation." Cardiology Review.
[6] Heit, J. A., et al. (2016). "Incidence of Venous Thromboembolism." Vascular Medicine.
[7] Patel, M. R., et al. (2019). "Efficacy and Safety of Rivaroxaban." New England Journal of Medicine.
[8] Schulman, S., et al. (2017). "Bleeding Risk in DOACs." Blood.
[9] Centers for Medicare & Medicaid Services. (2022). "Medicare Part D Drug Pricing & Coverage."
[10] European Medicines Agency. (2022). "HTA Framework Updates."
[11] Japanese Ministry of Health, Labour and Welfare. (2021). "Anticoagulant Policy Reforms."
[12] U.S. Patent & Trademark Office. (2023). "Patent Status of XARELTO."

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Key Takeaways:

• XARELTO's market position is reinforced by clinical advantages and expanding indications.
• Revenue forecasts project sustained growth, tempered by patent expiry risks.
• Strategic focus on emerging markets and biosimilar pathway management is critical.
• Regulatory and health policy landscapes will shape future competitiveness.
• Continuous safety monitoring and innovation are essential to maintain market dominance.

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This comprehensive review aims to inform strategic decisions for stakeholders, including investors, pharmaceutical executives, and policy-makers engaged with XARELTO.