XARELTO Drug Patent Profile

When do Xarelto patents expire, and what generic alternatives are available?

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. Nineteen 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
U.S. Food and Drug Administration (FDA)	PHASE4
VA Office of Research and Development	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	7,157,456*PED				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	7,157,456*PED				Y

Expired US Patents for XARELTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	7,585,860
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011	7,592,339
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011	7,585,860
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011	7,585,860

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
Taiwan	I277615
European Patent Office	1261606	OXAZOLIDINONES SUBSTITUEES ET LEUR UTILISATION DANS LE DOMAINE DE LA COAGULATION SANGUINE (SUBSTITUTED OXAZOLIDINONES AND THEIR USE IN THE FIELD OF BLOOD COAGULATION)
Japan	2003519141
World Intellectual Property Organization (WIPO)	0147919

Supplementary Protection Certificates for XARELTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	08C0051	France		PRODUCT NAME: RIVAROXABAN; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606	PA2008018	Lithuania		PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
1261606	C 2008 019	Romania		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	CA 2008 00050	Denmark		PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS

Market Dynamics and Financial Trajectory for XARELTO (Rivaroxaban)

Last updated: December 27, 2025

Executive Summary

XARELTO (rivaroxaban), a direct oral anticoagulant (DOAC) developed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), has established itself as a leading therapy for thromboembolic disorders. Launched in 2011, XARELTO’s market penetration has been rapid, driven by its efficacy, ease of use, and favorable safety profile compared to traditional anticoagulants like warfarin. This report analyzes XARELTO’s current market dynamics, including competitive landscape, regulatory environment, and sales trajectory, with projections for future growth. It synthesizes key data points, competitive positioning, and strategic challenges impacting its financial prospects.

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Market Overview and Current Landscape

Global Market Size

Metrics	2022 Data	Notes
Global anticoagulant market value	~$6.2 billion[1]	Expected to reach ~$8 billion by 2028[2]
XARELTO’s global sales	~$6.2 billion[3]	Nearly 100% of Janssen’s revenues from XARELTO in 2022

Therapeutic Indications

Indications	Market Share (2022)	Claims
Atrial fibrillation (AFib) for stroke prevention	65% of XARELTO sales	First-line therapy in non-valvular AFib (NVAF)
Deep vein thrombosis (DVT) and pulmonary embolism (PE)	Dominant	Often prescribed for secondary prevention
Postoperative thromboprophylaxis	Growing	Major orthopedic surgeries
Other indications	Emerging	Coronary artery disease (CAD), peripheral artery disease (PAD)

Competitive Landscape

Competitors	Market Share (2022)	Notes
Warfarin	35-40%	Declining due to DOACs popularity
Eliquis (apixaban)	~29%	Leading DOAC, aggressive marketing
XARELTO (rivaroxaban)	~25%	Market leader among DOACs
Savaysa (edoxaban)	4-5%	Smaller niche
Other (edoxaban, betrixaban, dabigatran)	<5%	Limited market penetration

Data refer to global sales estimates and market share proportions, as per IQVIA 2022 reports[3][4].

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Market Dynamics

Driving Forces

• Clinical Advantage and Prescriber Preference: XARELTO's once-daily dosing (versus Eliquis's twice-daily regimen) enhances compliance for many patients, influencing physician prescribing habits.
• Regulatory Approvals: Expanded indications, including treatment of certain cardiovascular conditions, bolster market size.
• Wider Adoption: Growing acceptance in primary care and cardiology settings facilitates increased volume.
• Reimbursement Policies: Favorable coverage through Medicare and private insurers has reduced barriers.

Challenges Impacting Growth

• Intense Competition: Eliquis's superior safety profile for gastrointestinal bleeding and established market presence pressures XARELTO.
• Generic Penetration: Patent expirations (notably in 2024) may accelerate generic competition, reducing revenues.
• Safety Concerns: Rare but serious adverse events, such as bleeding risks, influence prescribing decisions.
• Pricing Pressure: Price erosion in mature markets due to payers' negotiations.

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Financial Trajectory

Historical Sales Performance (2011-2022)

Year	Global Sales (USD billions)	CAGR	Highlights
2011	—	—	Launch year, initial adoption
2015	~$3.0	50%	Regulatory approvals expanded
2018	~$5.0	13.3%	Broadened indications
2022	~$6.2	7.8%	Peak revenue, market saturation

Source: IQVIA and company disclosures[3][5].

Projected Sales Outlook (2023-2030)

Projection Year	Expected Revenue (USD billions)	Assumptions
2023	~$6.4	Slight growth with patent stability
2024	~$6.8	Patent cliff initiating, decline begins
2025-2027	~$5.0 - $5.8	Increasing generic competition impacts
2028-2030	~$4.0 - $5.0	Market correction; new indications could stabilize revenues

Note: The projected decline post-2024 reflects patent expiry and market entry of generics; however, lifecycle extension strategies may buffer declines.

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Regulatory and Patent Landscape

Milestone	Date	Impact
Patent expiration (U.S.)	March 2024	Opens market for generics, pressure on pricing
European Patent Expiry	2024-2025	Similar effect in Europe
New Indications Approvals	2020-2022	Expanding revenue streams

Lifecycle Management: Janssen’s strategy includes development of fixed-dose combinations (e.g., XARELTO + aspirin) and new indications to extend market exclusivity.

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Strategic Challenges and Opportunities

Risks

• Patent cliff leading to revenue erosion.
• Competitive innovations (e.g., reversal agents, novel anticoagulants).
• Regulatory shifts affecting approval pathways.

Opportunities

• Q3/Q4 2023 Patent Litigation: Positive outcomes could prolong exclusivity.
• Expansion into Emerging Markets: Rapid growth potential in Asia-Pacific and Latin America.
• Innovation in Indications: Expanding use in stroke prevention for atrial flutter, cancer-associated thrombosis.
• Combination Therapies: Developing fixed-dose combinations with antiplatelet agents for dual indications.

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Comparative Analysis: XARELTO vs. Key Competitors

Attribute	XARELTO	Eliquis	Savaysa	Dabigatran
Dosing Frequency	Once daily	Twice daily	Once daily	Twice daily
Approved Indications	Broad (AFib, DVT, PE)	Broad (more established in AFib)	Limited (DVT, PE)	DVT, PE, stroke prevention
Bleeding Risks	Slightly higher than Eliquis	Lower gastrointestinal bleeding	Limited data	Higher bleeding risk
Patent Status (2024)	Pending expiration	Expired (Dabigatran)	Pending expiration	Expired
Market Share (2022)	~25%	~29%	4-5%	Small niche

Sources: IQVIA reports, peer-reviewed literature, company disclosures[3][4][5].

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Future Outlook and Key Strategic Factors

1. Patent Expiry and Generic Entry: Post-2024, expect increased price competition; Janssen’s pipeline and lifecycle strategies critical.
2. Innovation and Pipeline Development: New indications and combination therapies can supplement declining revenues.
3. Market Penetration in Emerging Markets: Rapid demographic shifts and rising cardiovascular disease prevalence boost potential.
4. Regulatory Navigation: Streamlined approval processes for new formulations or indications enhance growth prospects.
5. Competitive Positioning: Marketing efforts emphasizing safety, convenience, and new indications will be pivotal.

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Key Takeaways

• XARELTO's success stems from its ease of use, broad indications, and established clinical profile, leading to sustained high sales since 2011.
• Market share dominance faces erosion due to patent expiry in 2024 and the rise of generics, particularly in mature markets.
• Competitive pressure from Eliquis and emerging therapies necessitates continuous innovation, lifecycle management, and geographic expansion.
• Financial projections indicate peak revenues approaching mid-2020s, followed by a decline unless bolstered by new indications or formulations.
• Strategic initiatives including pipeline expansion, patent litigation, and market penetration are essential to sustain long-term growth.

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FAQs

1. What are the primary drivers of XARELTO's market growth?

The drug’s once-daily dosing, approval for multiple indications (AFib, DVT, PE), and favorable safety profile compared to warfarin drive its adoption and growth, especially in aging populations with cardiovascular risks.

2. How will patent expiration affect XARELTO's revenue?

Patent expiration slated for 2024 in the U.S. will enable generics to enter the market, potentially leading to significant revenue declines unless Janssen leverages lifecycle extensions through new formulations, indications, or legal strategies.

3. Who are the main competitors, and how does XARELTO compare?

Eliquis (apixaban) is the primary competitor, with similar efficacy but differing safety profiles and dosing regimens. Eliquis maintains a slight market lead due to its safety profile. Other competitors include Savaysa and dabigatran, with smaller market shares.

4. What growth opportunities exist post-2024?

Expansion into emerging markets, development of combination therapies, new indications (e.g., stroke prevention in atrial flutter), and lifecycle management strategies offer growth avenues despite patent challenges.

5. What are the main risks facing XARELTO's future?

Patent expiry, intense competition, regulatory hurdles, safety concerns, and pricing pressures constitute significant risks that could impact future sales and profitability.

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References

[1] IQVIA Institute. (2022). Global Pharmaceutical Markets.
[2] MarketsandMarkets. (2022). Anticoagulant Market Forecast to 2028.
[3] Janssen Pharmaceuticals. (2023). XARELTO Annual Report.
[4] IQVIA. (2022). Medicine Use and Spending in the US.
[5] Johnson & Johnson. (2022). Annual Financial Report.