XARELTO Drug Patent Profile

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

Xarelto is a drug marketed by Janssen Pharms and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-nine patent family members in twenty-five countries.

The generic ingredient in XARELTO 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 Xarelto

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

Summary for XARELTO

International Patents:	29
US Patents:	1
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
VA Office of Research and Development	PHASE4
U.S. Food and Drug Administration (FDA)	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 one US patents.

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

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
Hungary	0203902
Hong Kong	1103235
South Korea	20070044075
Netherlands	300370
Turkey	200201636
Japan	4852423

Supplementary Protection Certificates for XARELTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	300370	Netherlands
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	C01261606/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
1261606	PA2008018	Lithuania		PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
1261606	2008/030	Ireland		PRODUCT NAME: RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS.; REGISTRATION NO/DATE: EU/1/08/472/001-008 20080930
1261606	PA2008018,C1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930

Market dynamics and financial trajectory for Xarelto (rivaroxaban)

Last updated: February 16, 2026

Xarelto, developed by Bayer and jointly marketed with Janssen Pharmaceuticals, is an oral anticoagulant used primarily for stroke prevention in non-valvular atrial fibrillation (NVAF), treatment and prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), and reduction of thrombotic events post-orthopedic surgery.

Market Size and Growth Drivers

The global anticoagulant market, valued at approximately $11 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2027. Xarelto accounts for about 35-40% of the market share in the direct oral anticoagulants (DOACs) segment, positioning it as a leading product.

Key factors fueling growth:

• Increasing prevalence of atrial fibrillation (AF): Estimated to affect 37 million globally by 2030.
• Rise in anticoagulation therapy prescriptions: Driven by aging populations and expanded indications.
• Market penetration in emerging economies: Enhanced access and local regulatory approvals.
• Adoption in orthopedic procedures: DVT and PE prophylaxis post-joint replacement surgeries.

Competitive Landscape

Xarelto faces competition from other DOACs:

Product	Company	Indications	Market Share (2022)	Key Differentiator
Pradaxa (dabigatran)	Boehringer Ingelheim	AF, DVT, PE	20%	Reversal agent availability
Eliquis (apixaban)	Pfizer/Bristol-Myers	AF, DVT, PE, post-surgical prophylaxis	30-35%	Lower bleeding risk, extensive data
Edoxaban (Savaysa)	Daiichi Sankyo	AF, DVT, PE	5-7%	Once-daily dosing

Xarelto's market share is challenged by Eliquis’s superior safety profile and broader supportive data, but its early market entry and widespread physician familiarity sustain its position.

Revenue and Financial Performance

In 2022, Xarelto generated approximately $3.2 billion globally. Bayer's 2022 report indicates:

• Net sales for Xarelto: €2.5 billion (~$2.7 billion), representing roughly 8% of Bayer’s total pharmaceutical sales.
• Growth rate: Stable at approximately 4-6% YoY, driven by new indications and geographic expansion.

Financial contributions are concentrated in North America (≈55%), followed by Europe (≈30%). Patent exclusivity issues have historically influenced revenue trajectories; the key patent expired in the U.S. in 2024, opening the market to generics.

Patent and Regulatory Landscape

• Patent Status: U.S. patents expired in March 2024, leading to increased generic competition.
• Regulatory approvals: Xarelto received FDA approval in 2011, with additional approvals for indications in multiple countries.
• Legal challenges: Bayer faced over 25,000 lawsuits alleging adverse events, leading to a settlement fund of $1.6 billion announced in 2019.

Pricing and Market Access

Pricing strategies vary:

• In the U.S., list prices hover around $500–$600 per month.
• In Europe, prices range from €120–€250 per month based on country and indication.
• Payers prefer formulations with proven clinical benefits, with rebates and discounts affecting actual net prices.

Future Market Trajectory

Forecasted revenue decline post-patent expiry is expected:

Scenario	Estimated Revenue	Timeframe
Conservative	$1.3 billion (2025)	2025-2027
Aggressive generic entry	Decline to <$500 million (2025-2026)	2026+

Bayer aims to offset patent expiry impacts through:

• Label expansions: New indications such as prophylaxis in certain cardiovascular conditions.
• Combination therapies: Trials combining Xarelto with antiplatelets.
• Geographic expansion: Increasing penetration in emerging markets.

Regulatory Outlook and Pipeline Developments

No significant upcoming regulatory hurdles are expected beyond patent-related challenges. Bayer continues development of next-generation anticoagulants and formulations to maintain competitiveness.

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Key Takeaways

• Xarelto commands a leading position in the DOAC sector, with a substantial share of an expanding market.
• Revenue growth is driven by increasing adoption, though patent expiry and generic competition pose risks.
• Market dynamics are influenced by safety profiles, clinician preferences, and pricing strategies.
• Bayer’s strategies focus on expanding indications and markets to sustain revenues.

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FAQs

1. How will patent expiry impact Xarelto’s sales?
The expiration of U.S. patents in 2024 is expected to reduce revenue significantly due to increased generic competition, with estimates indicating a decline to under $500 million by 2026 unless offset by new indications or formulations.

2. What is the competitive advantage of Eliquis over Xarelto?
Eliquis has demonstrated a lower bleeding risk profile and extensive clinical trial data, which influences prescriber preferences despite Xarelto's earlier market entry.

3. Are there new indications that could boost Xarelto sales?
Yes. Bayer is seeking approval for additional uses such as prophylaxis in certain cardiovascular diseases, which could bolster growth if approved.

4. How does pricing influence Xarelto’s market share?
Pricing, combined with insurance coverage and rebates, impacts prescribing patterns. Higher list prices are common, but payers often negotiate discounts, especially as generics enter the market.

5. What are the major legal and regulatory risks facing Xarelto?
Ongoing litigation regarding adverse events and patent disputes pose risks, potentially affecting sales and leading to financial liabilities.

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References

1. Bayer Annual Report 2022.
2. MarketResearch.com. "Global Anticoagulants Market Report," 2022.
3. FDA. "Xarelto New Drug Application and Approvals," 2011.
4. Reuters. "Bayer Announces $1.6 Billion Settlement over Xarelto Litigation," 2019.
5. IQVIA, "Pharmaceutical Market Data," 2022.