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, 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. Twenty-one 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:	17
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	381
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
Regeneron Pharmaceuticals	PHASE3
Xuanwu Hospital, Beijing	PHASE4
Parexel	PHASE1

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
Msn	RIVAROXABAN	rivaroxaban	TABLET;ORAL	208546-002	Oct 24, 2025		DISCN	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: February 19, 2026

Rivaroxaban, marketed as Xarelto by Bayer, is an oral anticoagulant used for stroke prevention in atrial fibrillation, treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE). Since its approval in 2011, it has captured significant market share in the anticoagulant segment.

Market Size and Growth Trends

Global Market Valuation

• The global rivaroxaban market was valued at approximately $7.8 billion in 2022.
• Compound annual growth rate (CAGR) projected at 7.2% from 2023 to 2030.

Geographic Distribution

Region	2022 Market Share	CAGR (2023-2030)
North America	45%	6.8%
Europe	30%	7.4%
Asia-Pacific	15%	8.1%
Rest of World	10%	7.0%

Drivers of Growth

• Increasing prevalence of atrial fibrillation and venous thromboembolism.
• Growing adoption of direct oral anticoagulants (DOACs) over warfarin.
• Expanding approval for new indications, including knee and hip replacements.

Competitive Landscape

Major Competitors

• Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer): Market leader with ~45% share in anticoagulants.
• Dabigatran (Pradaxa, Boehringer Ingelheim): Holds ~10-12%.
• Edoxaban (Lixiana, Daiichi Sankyo): Smaller share, growing in Japan and Europe.

Bayer’s Position

• Approximately 26% market share in anticoagulants as of 2022.
• Revenue from rivaroxaban in 2022 reached ~$3.2 billion.

Patent Status and Generics

• Patent expired or will expire in key markets by 2024.
• Several pharmaceutical companies have filed ANDAs for generic rivaroxaban.
• Trademark protections in some jurisdictions may delay generic entry.

Financial Trajectory

Revenue Trends

Year	Revenue (USD billion)	Growth Rate
2018	2.8	N/A
2019	3.0	7.1%
2020	3.3	10%
2021	3.7	12.1%
2022	3.2 (estimated)	-13.5%

Profitability Outlook

• Margins have been stable at approximately 40% operating margin.
• Post-patent expiration, revenue decline expected absent new indications or formulations.

New Indications and Formulations

• Ongoing trials for venous thromboembolism prophylaxis in cancer patients.
• Development of combination therapies to expand use cases.

Regulatory and Market Risks

• Entry of generics in 2024 could reduce prices by 40-60%.
• Competition from newer anticoagulants with improved safety profiles.
• Regulatory delays or safety concerns can impact sales.

Policy and Pricing Environment

Regulatory Approvals

• Approved in over 140 countries.
• Recently received expanded indications in the U.S. for pulmonary embolism treatment in 2022.

Pricing Trends

• Branded pill in North America priced around $5–$7 per tablet.
• Insurance coverage and pharmacy benefit management influence net pricing.

Reimbursement Policies

• Favorable reimbursement in developed markets.
• Some countries imposing price caps to curb healthcare costs.

Outlook Summary

The pharmaceutical market for rivaroxaban will face revenue erosion from patent expiry, but this may be offset by increasing global healthcare needs. The focus on expanding indications and combination therapy development aims to maintain revenue streams. Competition from domestic generics, along with pricing and regulatory pressures, will influence the financial journey.

Key Takeaways

• The global rivaroxaban market is sizable, with 2022 valuation at approximately $7.8 billion and growth forecasted at over 7% annually.
• The market share is dominated by Apixaban and warfarin, but rivaroxaban maintains a strong position, especially in Europe and Asia-Pacific.
• Patent expiry in major markets in 2024 will prompt entry of generics, potentially halving prices.
• Bayer’s revenue from rivaroxaban peaked at around $3.2 billion in 2022, with growth pre-2022 driven mainly by new indications.
• The future trajectory depends on development pipeline success, regulatory environment, and competitive dynamics.

FAQs

1. When will generic rivaroxaban enter the market?
Patent expiry is expected in major markets like the U.S. and Europe by 2024, enabling generic manufacturers to seek approval and market entry.

2. How will patent loss affect rivaroxaban revenue?
Generic entry is projected to reduce prices by up to 60%, leading to a decline in revenue unless compensated by new indications or formulations.

3. What are the main competitors to rivaroxaban?
Apixaban (Eliquis) is the market leader, with dabigatran (Pradaxa) and edoxaban (Lixiana) as notable secondary competitors.

4. Are there recent regulatory updates for rivaroxaban?
Yes; in 2022, the FDA approved expanded uses in pulmonary embolism treatment, possibly extending its revenue lifecycle.

5. What is the outlook for rivaroxaban in emerging markets?
Growing healthcare infrastructure and increasing thrombotic disease prevalence support expanding access but price sensitivity and regulatory hurdles may slow growth.

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References

[1] MarketResearch.com. (2023). Rivaroxaban market analysis.
[2] Bayer. (2023). Xarelto product sales and pipeline updates.
[3] Grand View Research. (2023). Anticoagulants market size and forecasts.
[4] U.S. Food and Drug Administration. (2022). Labeling and approval updates for rivaroxaban.