RIVAROXABAN Drug Patent Profile

Which patents cover Rivaroxaban, and what generic alternatives are available?

Rivaroxaban is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Aiping Pharm Inc, Alembic, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Biocon Pharma, Breckenridge, Dr Reddys, Invagen Pharms, Macleods Pharms Ltd, MSN, Regcon Holdings, Sciegen Pharms Inc, Sunshine, and Taro. and is included in nineteen NDAs.

The generic ingredient in RIVAROXABAN 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 Rivaroxaban

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

Summary for RIVAROXABAN

US Patents:	0
Applicants:	17
NDAs:	19
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	378
Patent Applications:	4,904
Drug Prices:	Drug price information for RIVAROXABAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIVAROXABAN
DailyMed Link:	RIVAROXABAN at DailyMed

See drug prices for RIVAROXABAN

Recent Clinical Trials for RIVAROXABAN

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

Sponsor	Phase
University of Melbourne	PHASE4
Emily McDonald	PHASE4
McMaster University	PHASE3

See all RIVAROXABAN clinical trials

Pharmacology for RIVAROXABAN

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Medical Subject Heading (MeSH) Categories for RIVAROXABAN

Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RIVAROXABAN

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for RIVAROXABAN

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 RIVAROXABAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	RIVAROXABAN	rivaroxaban	TABLET;ORAL	213114-002	May 14, 2025	AB	RX	No	No
Dr Reddys	RIVAROXABAN	rivaroxaban	TABLET;ORAL	208534-004	May 14, 2025	AB	RX	No	No
Regcon Holdings	RIVAROXABAN	rivaroxaban	TABLET;ORAL	218445-002	Aug 11, 2025	AB	RX	No	No
Taro	RIVAROXABAN	rivaroxaban	TABLET;ORAL	208557-002	Oct 7, 2025	AB	RX	No	No

EU/EMA Drug Approvals for RIVAROXABAN

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

Market Dynamics and Financial Trajectory for Rivaroxaban

Last updated: January 12, 2026

Executive Summary

Rivaroxaban, marketed primarily under the brand name Xarelto, is a direct oral anticoagulant (DOAC) developed by Janssen Pharmaceuticals (Johnson & Johnson). Since its approval in 2011, rivaroxaban has cemented its pivotal role in thrombosis management, including atrial fibrillation (AF), deep vein thrombosis (DVT), and pulmonary embolism (PE). Its unique pharmacological profile, market penetration, competitive landscape, and evolving regulatory environment collectively influence its financial trajectory and future growth prospects. This comprehensive analysis elucidates key market dynamics, financial forecasts, competitive factors, and strategic considerations for stakeholders.

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1. Introduction to Rivaroxaban and Its Therapeutic Indications

Pharmacological Profile

Feature	Details
Mechanism of Action	Direct Factor Xa inhibitor
Onset of Action	Rapid; within 2-4 hours
Half-Life	5-9 hours (young) / up to 13 hours (elderly)
Dosing	Once daily or twice daily, depending on indication
Metabolism	Hepatic (CYP3A4, CYP2J2 pathways)
Reversal Agent	Andexanet alfa (approved in 2018)

Major Clinical Uses

• Stroke prevention in non-valvular atrial fibrillation
• Treatment and secondary prevention of DVT and PE
• Post-operative thromboprophylaxis following hip or knee replacement

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2. Market Dynamics

2.1 Global Market Size and Growth

The global anticoagulant market, estimated at $8.8 billion in 2022, is projected to reach $13.2 billion by 2030, exhibiting a compound annual growth rate (CAGR) of approximately 6.1% (2023-2030) [1].

Rivaroxaban’s market share among DOACs accounted for roughly 44% in 2022, constituting the second-largest segment after apixaban (Eliquis). Its sales volume notably increased post-approval, driven by expanding indications and clinical data confirming its efficacy and safety.

2.2 Regional Market Distribution

Region	Market Share (2022)	Growth Drivers
North America	45%	High adoption in AF and DVT, extensive healthcare infrastructure
Europe	30%	Reimbursement policies, aging population
Asia-Pacific	15%	Rapidly increasing prevalence of thrombotic conditions, rising awareness
Rest of World	10%	Emerging economies, limited accessibility

2.3 Key Market Drivers

• Innovative clinical data confirming rivaroxaban’s efficacy over warfarin
• Simplified dosing schedule enhancing patient adherence
• Expanding indications including use in cancer-associated thrombosis
• Regulatory approvals granting expanded use in multiple jurisdictions

2.4 Market Challenges

• Competition from other DOACs: apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa)
• Patent expirations: imminent in certain markets (e.g., 2024-2025 in U.S.)
• Pricing pressures and reimbursement hurdles
• Blood coagulation reversal concerns post-administration

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3. Competitive Landscape

Competitor	Key Features	Market Share (2022)	Unique Advantages
Eliquis (apixaban)	Factor Xa inhibitor, high safety profile	42%	Lower bleeding risk, preferred by cardiology specialists
Pradaxa (dabigatran)	Direct thrombin inhibitor	8%	First oral anticoagulant approval, effective in stroke prevention
Edoxaban (Savaysa)	Factor Xa inhibitor	4%	Cost-effective, approved for EVAR (Ecarxaban)

Market Positioning of Rivaroxaban

• Strengths: Once-daily dosing, broad indications, extensive clinical validation
• Weaknesses: Patent cliff approaching, competition from apixaban with better safety profile

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4. Regulatory and Policy Environment

4.1 Approvals Timeline & Key Regulatory Decisions

Year	Event	Impact
2011	FDA approval for DVT/PE treatment	Breakthrough in oral anticoagulation therapy
2012	EMA approval for stroke prevention in AF	Expanded market access
2018	Approval of Andexanet alfa as reversal agent	Addressed bleeding risk concerns
2020+	Expansion of indications (e.g., PCI, cancer-related thrombosis)	Diversified revenue streams

4.2 Reimbursement Policies

• Accessibility varies by region; high reimbursement in the U.S. and Europe supports volume growth
• Price negotiations and patent expirations pose potential barriers

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5. Financial Trajectory and Revenue Forecasts

5.1 Revenue Trends (2011–2022)

Year	Global Sales (in Billion USD)	Key Factors
2011	$0.1	Initial launch
2015	$2.1	Broader indications, increased adoption
2020	$4.5	Pandemic-driven healthcare shifts, digital marketing
2022	$5.2	Market maturing, increased competition

5.2 Projected Revenue Outlook (2023–2030)

Year	Forecasted Sales (in Billion USD)	Assumptions
2023	$6.0	Growing indications, expanding in Asia-Pacific
2025	$8.0	Patent cliff impacts, biosimilar competition begins
2030	$12.8	Market expansion and consolidations

5.3 Key Factors Influencing Financial Trajectory

• Patent expiration: European patent expiry in 2024; U.S. patents in 2025
• Biosimilar and generic entry: Potential price erosion
• Innovation pipeline: New formulations, oral anticoagulants, and combination therapies
• Strategic alliances: Licensing and co-marketing agreements

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6. Strategic Considerations for Stakeholders

6.1 Opportunities

• Expansion in emerging markets, especially China and India
• Development of next-generation formulations with improved safety/efficacy
• Strategic partnerships for biosimilar or generic versions

6.2 Risks

• Patent expirations resulting in revenue decline
• Market share erosion due to competing DOACs
• Regulatory hurdles and reimbursement challenges
• Long-term safety concerns (e.g., bleeding risks)

6.3 Innovation and R&D Outlook

• Focused on developing reversal agents with broader applicability
• Personalized medicine approaches to optimize dosing and reduce adverse events
• Digital health integration for adherence monitoring

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7. Comparative Analysis: Rivaroxaban versus Key Competitors

Parameter	Rivaroxaban (Xarelto)	Apixaban (Eliquis)	Dabigatran (Pradaxa)	Edoxaban (Savaysa)
Approved Indications	Stroke, DVT, PE, PCI	Stroke, DVT, PE	Stroke, DVT, PE	Stroke, DVT
Dosing Frequency	Once daily	Twice daily	Twice daily	Once daily
Bleeding Risk	Moderate	Lower	Moderate to high	Moderate
Reversal Agent	Andexanet alfa	Andexanet alfa	Idarucizumab	Andexanet alfa
Patent Status in US	Expires 2025	Active until 2031	Active until 2030	Active until 2029

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8. Frequently Asked Questions

Q1: What factors determine rivaroxaban's market share relative to other DOACs?

Market share is influenced by efficacy, safety profile, dosing convenience (once vs. twice daily), clinician familiarity, regulatory approvals, and reimbursement policies.

Q2: How will patent expiration affect rivaroxaban’s revenue?

Patent expiry, particularly in major markets (2024-2025), will open the market to biosimilars and generics, likely causing significant price erosion and revenue decline unless offset by new indications or formulations.

Q3: What are the primary regulatory hurdles faced by rivaroxaban?

Regulatory challenges include approving new indications, ensuring safety monitoring, and gaining acceptance for biosimilar entries, especially amidst concerns about bleeding risks and reversal options.

Q4: How do biosimilars influence rivaroxaban's future?

While biosimilars are less common for small molecules like rivaroxaban, generic versions post-patent expiration will increase market competition, lowering prices but risking profitability.

Q5: What emerging trends could reshape rivaroxaban's market?

Innovations include personalized dosing algorithms, safer formulations, enhanced reversal agents, and integration with digital health tools for compliance monitoring.

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9. Key Takeaways

• Market Positioning: Rivaroxaban remains a significant player in anticoagulant therapy, driven by broad indications and clinical data; however, its growth margin faces pressure from patent expirations and competing products.

• Revenue Forecast: Anticipate a peak in sales around 2024-2025, followed by potential decline due to biosimilar entry, unless metastatic growth opportunities emerge in niche segments or new indications.

• Strategic Focus: Enhancing formulation safety, developing next-generation reversal agents, and expanding into emerging markets are essential to sustain revenue streams.

• Competitive Dynamics: Apixaban remains rivaroxaban’s closest competitor, often outperforming in safety, emphasizing the importance of clinical evidence in market share retention.

• Regulatory Landscape: Rapid approval of indications and biosimilars will shape future revenues, necessitating proactive regulatory strategies.

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References

[1] Clarivate. "Global Oral Anticoagulants Market Report," 2023.
[2] IQVIA. "Pharmaceutical Market Dynamics RX," 2022.
[3] Johnson & Johnson. "Xarelto Prescribing Information," 2022.
[4] European Medicines Agency (EMA). "Regulatory updates on anticoagulants," 2022.
[5] FDA. "Approval of Andexanet alfa," 2018.

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This analysis aims to arm industry professionals with comprehensive insights into rivaroxaban’s market trajectory, aiding strategic decision-making in a competitive, evolving landscape.