RIVAROXABAN - Generic Drug Details

What are the generic sources for rivaroxaban and what is the scope of freedom to operate?

Rivaroxaban is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Lupin Ltd, Janssen Pharms, 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 twenty NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rivaroxaban has one hundred and fifty-six patent family members in forty-seven countries.

There are thirty-five drug master file entries for rivaroxaban. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for RIVAROXABAN

International Patents:	156
US Patents:	4
Tradenames:	2
Applicants:	18
NDAs:	20
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	375
Patent Applications:	7,226
Drug Prices:	Drug price trends for RIVAROXABAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIVAROXABAN
What excipients (inactive ingredients) are in RIVAROXABAN?	RIVAROXABAN excipients list
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
National Heart, Lung, and Blood Institute (NHLBI)	EARLY_PHASE1

See all RIVAROXABAN clinical trials

Generic filers with tentative approvals for RIVAROXABAN

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET;ORAL
		15MG	TABLET;ORAL
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Regcon Holdings	RIVAROXABAN	rivaroxaban	TABLET;ORAL	218445-004	Aug 11, 2025	AB	RX	No	No
Aiping Pharm Inc	RIVAROXABAN	rivaroxaban	TABLET;ORAL	216995-001	May 14, 2025	AB	RX	No	No
Biocon Pharma	RIVAROXABAN	rivaroxaban	TABLET;ORAL	218107-002	May 14, 2025	AB	RX	No	No
Msn	RIVAROXABAN	rivaroxaban	TABLET;ORAL	208546-003	Oct 24, 2025		DISCN	No	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011	AB	RX	Yes	No

Expired US Patents for RIVAROXABAN

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	022406-001	Jul 1, 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	022406-001	Jul 1, 2011

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

International Patents for RIVAROXABAN

Country	Patent Number	Title	Estimated Expiration
Norway	20062942
Ukraine	73339	SUBSTITUTED OXAZOLIDINONES AND USE THEREOF FOR THE PREVENTION OF BLOOD COAGULATION
Russian Federation	2379036	СПОСОБ ИЗГОТОВЛЕНИЯ ТВЕРДОГО, ОРАЛЬНО ПРИМЕНИМОГО ФАРМАЦЕВТИЧЕСКОГО СОСТАВА (METHOD FOR MAKING SOLID ORAL PHARMACEUTICAL COMPOSITION)
Morocco	28178	PROCEDE POUR PRODUIRE UNE COMPOSITION PHARMACEUTIQUE SOLIDE A APPLICATION ORALE
Poland	1689370

Supplementary Protection Certificates for RIVAROXABAN

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	361	Finland
1261606	CA 2008 00050	Denmark		PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
1261606	48/2008	Austria		PRODUCT NAME: RIVAROXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/08/472/001 - EU/1/08/472/008 20080930

Market Dynamics and Financial Trajectory for Rivaroxaban

Last updated: October 25, 2025

---

Introduction

Rivaroxaban, marketed under brand names such as Xarelto, is an oral anticoagulant developed by Bayer and Johnson & Johnson. Approved by the U.S. Food and Drug Administration (FDA) in 2011, it has since become a leading agent in thrombosis management. Its innovative mechanism as a direct Factor Xa inhibitor has positioned rivaroxaban as a preferred alternative to traditional anticoagulants like warfarin. Analyzing its market dynamics and financial trajectory reveals insights into its growth potential, competitive landscape, and evolving therapeutic applications.

---

Market Overview and Segmentation

The global rivaroxaban market has experienced substantial growth, driven by the rising prevalence of atrial fibrillation (AF), deep vein thrombosis (DVT), pulmonary embolism (PE), and other thromboembolic disorders. According to Grand View Research, the anticoagulants market is projected to reach USD 15.4 billion by 2028, with rivaroxaban constituting a significant share due to its efficacy and safety profile (1).

The market is segmented primarily by application, route of administration, and end-user. The dominant application segments include stroke prevention in non-valvular AF, treatment of DVT and PE, and prophylaxis for orthopedic surgeries. The oral route remains the standard, with outpatient settings favoring rivaroxaban’s convenience over injectable alternatives.

---

Market Drivers

1. Increasing Disease Burdens

The global rise in cardiovascular diseases, particularly AF and venous thromboembolism, propels demand for effective anticoagulation therapy (2). The World Health Organization reports that stroke accounts for over 11% of total deaths worldwide, emphasizing the need for efficacious prophylactic agents like rivaroxaban.

2. Advantages over Traditional Therapy

Rivaroxaban’s advantages—fixed dosing, no routine coagulation monitoring, fewer drug-food interactions—have propelled its adoption over warfarin and other vitamin K antagonists (VKAs). Its predictable pharmacokinetics and pharmacodynamics reduce hospitalization and complications, supporting market expansion.

3. Expanded Indications and Approvals

Regulatory agencies have granted approval for new indications, including secondary prevention of cardiovascular events and treatment of additional thrombotic conditions. These broadened uses increase prescription volumes.

4. Patient Preference and Compliance

The oral, once-daily dosing regimen enhances patient adherence, reducing treatment discontinuation rates, a crucial factor in chronic anticoagulant therapies.

5. Strategic Collaborations and Patent Expirations

Partnerships between Bayer, Janssen, and other pharmaceutical entities facilitate research, marketing, and market expansion. Patent expiries in certain regions (e.g., Canada and some European countries by 2024) open opportunities for generic rivaroxaban products, influencing pricing dynamics and market share.

---

Market Challenges and Limitations

1. Competition from Other NOACs

Rivaroxaban faces competition from other novel oral anticoagulants (NOACs), such as apixaban (Eliquis), dabigatran (Pradaxa), and edoxaban (Lixiana). Comparative studies suggest differences in efficacy, bleeding risk, and dosing convenience, influencing prescriber preferences (3).

2. Safety Concerns and Contraindications

Despite safety advantages, concerns persist over bleeding risks, especially in vulnerable populations. The need for reversibility agents, such as andexanet alfa, remains critical for managing major hemorrhages.

3. Cost and Reimbursement Policies

While rivaroxaban offers economic benefits through reduced monitoring needs, higher drug acquisition costs remain a barrier in some healthcare systems. Insurance coverage disparities influence prescribing patterns.

4. Regulatory and Patent-Related Risks

Potential patent litigations, regulatory updates, and market access barriers can impact profitability and strategic planning.

---

Financial Trajectory: Revenue and Market Share

Since its launch, rivaroxaban has demonstrated robust revenue growth. Bayer's financial disclosures reveal that Xarelto accounted for significant revenue contributions—approaching EUR 3.4 billion in 2021—reflecting its prevalence and sales momentum (4). The drug’s growth trajectory aligns with increased global acceptance, expanded indications, and rising patient populations.

The trajectory is reinforced by the expanding geographic footprint, with emerging markets such as Asia-Pacific showing substantial growth potential. Market analysts project a compounded annual growth rate (CAGR) of approximately 8-10% over the next five years for rivaroxaban, driven by demographic shifts and clinical adoption (1).

---

Regulatory Developments and Market Expansion

The evolving regulatory landscape influences rivaroxaban’s market dynamics. Recent approvals for indications such as postoperative thromboprophylaxis in knee and hip replacement, atrial fibrillation stroke prevention, and secondary prevention in coronary artery disease (CAD) bolster its portfolio. Additionally, fast-track approvals and orphan drug designations can accelerate market penetration.

Furthermore, patent expirations in certain regions facilitate generic entry, intensifying competition but also offering price reductions that could expand access, especially in price-sensitive markets.

---

Impact of Patent Expirations and Generics

Patent expiry forecasts indicate that key patents covering rivaroxaban may lapse by 2024-2025 in various jurisdictions. This is expected to open the market to generics, exerting downward pressure on prices but expanding volume sales. Simultaneously, generic competitors may leverage price-driven strategies to capture market share, forcing branded drug manufacturers to innovate or diversify their portfolios.

---

Future Outlook and Strategic Implications

The future of rivaroxaban hinges on several factors:

• Innovative formulations and delivery systems: Extended-release or combination therapies could elevate convenience and adherence.
• Personalized medicine approaches: Pharmacogenomic insights may tailor anticoagulant therapy, optimizing safety and efficacy.
• Digital health integration: Monitoring and adherence tools could enhance therapeutic outcomes and patient engagement.
• Emerging markets: Targeted strategies in Asia, Africa, and Latin America serve as growth accelerants, benefitting from demographic trends.

Given these trajectories, global rivaroxaban revenues are projected to maintain a steady upward trend, with a diversified application spectrum and competitive pricing strategies being key determinants.

---

Key Takeaways

• Market Growth Drivers: The increasing burden of thromboembolic disorders and rivaroxaban’s clinical advantages underpin sustained market expansion.
• Competitive Landscape: Rivaroxaban contends with other NOACs, necessitating differentiation through safety, efficacy, and patient-centric features.
• Regulatory and Patent Trends: Market access benefits are enhanced via expanded indications, while patent expiries open channels for generics and price competition.
• Financial Trajectory: Revenues show resilient growth with projections indicating continued increase driven by global demand and emerging markets.
• Strategic Opportunities: Innovation in formulations, personalized therapy, and digital health integration represents future growth avenues.

---

FAQs

1. How does rivaroxaban compare to other NOACs in terms of efficacy?
Clinical trials demonstrate comparable efficacy between rivaroxaban and other NOACs like apixaban, with some studies suggesting a slight advantage in reducing certain bleeding risks, although patient-specific factors influence choice.

2. What are the primary safety concerns associated with rivaroxaban?
Major safety concerns include bleeding risks, particularly in patients with predispositions or concomitant use of other anticoagulants. Availability of reversal agents like andexanet alfa mitigates some safety issues.

3. Will rising patent expirations impact rivaroxaban’s market share?
Yes. Patent expirations forecasted for 2024-2025 are expected to introduce generics, which could decrease prices and influence brand loyalty, though they also increase accessibility and volume sales.

4. Which regions are expected to see the fastest growth for rivaroxaban?
Emerging economies within Asia-Pacific, Latin America, and parts of Africa are projected to experience rapid growth due to expanding healthcare infrastructure and increasing prevalence of thromboembolic conditions.

5. What strategic measures can pharmaceutical companies adopt to maintain competitiveness?
Focusing on innovation, expanding indications, improving patient adherence through digital integration, and engaging in strategic partnerships are crucial for maintaining market dominance.

---

References

1. Grand View Research. (2022). Anticoagulants Market Size, Share & Trends Analysis Report.
2. World Health Organization. (2019). Cardiovascular Diseases Fact Sheet.
3. Wojdyla, D. M., et al. (2014). "Comparison of bleeding risks among NOACs." Journal of Thrombosis & Haemostasis.
4. Bayer AG Annual Report 2021.

---

In conclusion, rivaroxaban continues to demonstrate robust growth driven by clinical efficacy, expanding indications, and strategic market positioning. The dynamic landscape characterized by competition, regulatory shifts, and patent expiries presents both challenges and opportunities for stakeholders committed to optimizing therapeutic outcomes and financial performance.