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 one branded drug marketed by Janssen Pharms and is included in two 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. Four suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for RIVAROXABAN

International Patents:	156
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	340
Patent Applications:	6,279
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RIVAROXABAN

Dosage:

TABLET;ORAL

Dosage:

FOR SUSPENSION;ORAL

^*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 RIVAROXABAN

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

Sponsor	Phase
China National Center for Cardiovascular Diseases	Phase 4
University Hospital, Angers	Phase 3
Zunyi Medical College	Phase 4

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

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/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

International Patents for RIVAROXABAN

Country	Patent Number	Title	Estimated Expiration
China	1434822
Norway	340156
Argentina	104840	COMPOSICIÓN FARMACÉUTICA SÓLIDA ADMINISTRABLE ORALMENTE, USO Y PROCEDIMIENTO PARA LA PROFILAXIS Y/O TRATAMIENTO DE ENFERMEDADES TROMBOEMBÓLICAS
Turkey	200201636
Norway	20070981

Supplementary Protection Certificates for RIVAROXABAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300370	Netherlands
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
1261606	PA2008018,C1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
1261606	91497	Luxembourg		91497, EXPIRES: 20230930

RIVAROXABAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Rivaroxaban

Introduction to Rivaroxaban

Rivaroxaban, a novel oral anticoagulant (NOAC), has revolutionized the treatment of various thrombotic disorders, including deep vein thrombosis, pulmonary embolism, and the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Here, we delve into the market dynamics and financial trajectory of this pivotal drug.

Market Size and Growth Projections

The global rivaroxaban market is estimated to be valued at USD 16.72 million in 2024 and is projected to reach USD 26.11 million by 2031, exhibiting a compound annual growth rate (CAGR) of 6.6% from 2024 to 2031[1][3].

Key Drivers of Market Growth

Several factors are driving the growth of the rivaroxaban market:

Rising Geriatric Population

The increasing geriatric population, which is more prone to cardiovascular diseases, is a significant driver. As people age, the risk of conditions such as atrial fibrillation and venous thromboembolism increases, thereby boosting the demand for anticoagulants like rivaroxaban[1][3].

Growing Awareness Among Physicians

Physicians are becoming more aware of the advantages of rivaroxaban over traditional anticoagulants like warfarin. Rivaroxaban's once-daily dosing and lack of need for routine blood monitoring make it a more convenient and patient-compliant option[1][5].

Expanding Clinical Indications

Rivaroxaban's indications have expanded beyond its initial approval for preventing stroke and embolism in patients with atrial fibrillation. It is now used to treat a variety of conditions, including deep vein thrombosis and pulmonary embolism, which has broadened its market share and accessibility[5].

Patent Expiry and Generic Versions

The impending patent expiry of rivaroxaban and the introduction of generic versions are expected to increase market penetration, especially in low and middle-income countries. Generic versions will make the drug more affordable, expanding its patient base[1][5].

Regional Market Dynamics

North America

North America currently dominates the global rivaroxaban market, with a significant share attributed to the presence of major pharmaceutical players like Bayer, Janssen, and Pfizer. The region's favorable regulatory environment and early adoption of new drugs also contribute to its large market size[1].

Asia Pacific

The Asia Pacific region is projected to be the fastest-growing market for rivaroxaban. Countries like China, India, Japan, and South Korea are experiencing rapid economic development, rising healthcare expenditure, and an increasing geriatric population, all of which are driving the demand for anticoagulants. The presence of key generic drug manufacturers in this region is also improving access to cheaper rivaroxaban alternatives[1].

Cost-Effectiveness and Budget Impact

Comparison with Dalteparin

Studies have shown that rivaroxaban is cost-effective compared to low molecular weight heparin (LMWH) like dalteparin in patients with cancer at risk of recurrent venous thromboembolism. Rivaroxaban can save significant costs, up to €11 million per year, primarily due to differences in drug costs[2].

Comparison with ASA in CAD and PAD

In patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD), rivaroxaban in combination with acetylsalicylic acid (ASA) is a cost-effective alternative to ASA alone. The incremental cost-effectiveness ratio (ICER) of £16,360 per quality-adjusted life-year (QALY) gained makes it a viable option within the UK's National Institute for Health and Care Excellence (NICE) threshold[4].

Market Opportunities and Challenges

Emerging Economies

Emerging economies in Asia Pacific and Latin America present significant opportunities for rivaroxaban due to improving healthcare systems, rising prevalence of cardiovascular diseases, and growing demand for effective anticoagulation therapies. Strategic partnerships and regional collaborations can help market players tap into these high-potential markets[1][5].

Generic Competition

The introduction of generic versions of rivaroxaban will increase competition but also make the drug more affordable, potentially expanding its market share. Pharmaceutical companies developing generic versions are poised to benefit from this shift[1][5].

Strategic Partnerships and Collaborations

Recent strategic partnerships and mergers between pharmaceutical companies have accelerated rivaroxaban's availability and market share. Collaborations with healthcare providers are also improving access to the drug for both physicians and patients[5].

Financial Trajectory

The financial trajectory of rivaroxaban is marked by steady growth driven by increasing demand and expanding clinical indications. Here are some key financial highlights:

• Market Value: Expected to grow from USD 16.72 million in 2024 to USD 26.11 million by 2031[1][3].
• Cost Savings: Rivaroxaban can lead to significant cost savings when compared to other anticoagulants, such as dalteparin, particularly in the treatment of cancer patients with venous thromboembolism[2].
• ICER: The ICER for rivaroxaban in combination with ASA compared to ASA alone is £16,360 per QALY, indicating its cost-effectiveness[4].

Key Takeaways

• Rivaroxaban is experiencing steady market growth driven by a rising geriatric population and growing awareness among physicians.
• The drug's once-daily dosing and lack of need for routine blood monitoring make it a preferred option.
• Expanding clinical indications and the introduction of generic versions are expected to further drive market growth.
• The Asia Pacific region is poised to be the fastest-growing market for rivaroxaban.
• Rivaroxaban is cost-effective compared to other anticoagulants in various clinical scenarios.

FAQs

What are the primary indications for rivaroxaban?

Rivaroxaban is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis, and prevention of pulmonary embolism[1][5].

How does rivaroxaban compare to traditional anticoagulants like warfarin?

Rivaroxaban offers a more convenient dosing regimen (once daily) and does not require routine blood monitoring, making it more patient-compliant compared to warfarin[1][5].

What is the impact of generic versions on the rivaroxaban market?

The introduction of generic versions of rivaroxaban is expected to make the drug more affordable, expanding its patient base and increasing market penetration, especially in low and middle-income countries[1][5].

Which regions are expected to drive the growth of the rivaroxaban market?

North America currently dominates the market, but the Asia Pacific region is projected to be the fastest-growing market due to rapid economic development, rising healthcare expenditure, and an increasing geriatric population[1].

Is rivaroxaban cost-effective compared to other anticoagulants?

Yes, rivaroxaban has been shown to be cost-effective compared to dalteparin in patients with cancer at risk of recurrent venous thromboembolism and compared to ASA alone in patients with CAD or PAD[2][4].

Cited Sources

1. Coherent Market Insights: Rivaroxaban Market - Share, Size and Industry Analysis.
2. BMJ Open: Cost-effectiveness analysis and budget impact of rivaroxaban...
3. Coherent Market Insights: Rivaroxaban Market Size and Trends.
4. Cardiovascular Research: Health economic evaluation of rivaroxaban in the treatment of...
5. Market Research Intellect: Rivaroxaban Market Size And Projection.