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XARELTO Drug Patent Profile

Which patents cover Xarelto, and when can generic versions of Xarelto launch?

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

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

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.

DrugPatentWatch^® Generic Entry Outlook for Xarelto

Xarelto was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2025. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $6.3bn, indicating a strong incentive for generic entry (peak sales were $7.2bn in 2020).

There have been thirty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are six tentative approvals for the generic drug (rivaroxaban), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XARELTO

International Patents:	156
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	124
Patent Applications:	4,093
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

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

Constraining patent/regulatory exclusivity:

9,415,053*PED

NDA:

022406

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

7,157,456*PED

NDA:

215859

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 XARELTO

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

Sponsor	Phase
Ottawa Hospital Research Institute	Phase 2/Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 2/Phase 3
Kidney Cancer Research Network of Canada	Phase 2/Phase 3

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 four US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,157,456.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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		RX	Yes	Yes	7,157,456*PED				Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No

Expired US Patents for XARELTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011	7,592,339
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	7,585,860
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011	7,585,860

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/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 XARELTO

See the table below for patents covering XARELTO around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	65683
Taiwan	I277615
Taiwan	I356702

Supplementary Protection Certificates for XARELTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	C01261606/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
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	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

XARELTO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XARELTO

Introduction to XARELTO

XARELTO, known generically as rivaroxaban, is a leading oral anticoagulant developed by Bayer and marketed in partnership with Janssen. It is used to treat various medical conditions, including deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation[1].

Market Size and Growth Projections

The global rivaroxaban market, which includes XARELTO, is projected to grow significantly. As of 2024, the market is estimated to be valued at USD 16.72 million and is expected to reach USD 26.11 million by 2031, exhibiting a compound annual growth rate (CAGR) of 6.6% from 2024 to 2031[1].

Driving Factors for Market Growth

Several factors are driving the growth of the rivaroxaban market:

• Growing Prevalence of Atrial Fibrillation and Venous Thromboembolism: The increasing incidence of these conditions, particularly among the geriatric population, is a significant driver. As the population ages, the demand for effective anticoagulants like rivaroxaban is on the rise[1].
• Advantages Over Traditional Anticoagulants: Rivaroxaban offers several advantages over warfarin, including easier dosing regimens and fewer dietary restrictions, which are appealing to both patients and physicians[1].
• Emerging Markets: The Asia Pacific and Latin America regions present significant opportunities due to rapid urbanization, growing geriatric populations, and increasing healthcare spending. These factors are driving up the demand for novel oral anticoagulants like XARELTO[1].

Challenges and Opportunities

Patent Expiry and Generic Competition

The patents for XARELTO are set to expire between 2023 and 2026, which will allow generic versions of rivaroxaban to enter the market. This is expected to reduce the prices of rivaroxaban products significantly, potentially impacting the revenues of major manufacturers. Companies will need to develop new strategies to maintain their market share in a post-patent expiry environment[1].

Market Expansion in New Indications

XARELTO is being explored for new indications, such as the treatment of Peripheral Artery Disease (PAD). This expansion could significantly boost the drug's market presence and sales. The drug's unique role in reducing the risk of major thrombotic vascular events in adult patients with PAD makes it a focal point for research and clinical development[4].

Financial Performance and Outlook

Bayer's Financial Health

Bayer, one of the primary companies behind XARELTO, has faced mixed financial results in recent years. In 2023, the company reported a net income of minus 2.941 billion euros, largely due to impairment losses and special charges. However, the Consumer Health division saw an increase in EBITDA before special items, driven by efficiency programs and successful price management[2].

For the first quarter of 2024, Bayer reported sales of 13.8 billion euros, slightly below the previous year's figure. The company's free cash flow improved due to lower litigation payouts, but it still faced significant FX headwinds and higher interest payments[5].

Impact on XARELTO Sales

The financial performance of Bayer and the overall market dynamics suggest that XARELTO's sales will continue to be strong, especially as it expands into new indications like PAD. However, the impending patent expiry and the introduction of generic versions will necessitate strategic adjustments to maintain market share and revenue.

Price Dynamics and Cost Implications

XARELTO has been one of the highest-selling drugs globally, with a significant price disparity between the U.S. and other countries. In 2020, it was the world's 10th highest-selling drug, and its price in the U.S. was 10 times higher than in other countries. This has led to substantial costs for healthcare systems, such as Medicare Part D, which spent over $46 billion on XARELTO and another anticoagulant, Eliquis, since 2015[3].

The lack of generic competition has allowed manufacturers to maintain high prices, a situation that is expected to change with the introduction of generic rivaroxaban. This could lead to a reduction in healthcare costs associated with XARELTO.

Clinical and Regulatory Pathway

XARELTO's clinical and regulatory pathway is well-established, with a distinct function as a selective inhibitor of Factor Xa. It is the sole therapy indicated for both coronary artery disease (CAD) and PAD post-lower extremity revascularization (LER). However, it carries a boxed warning for potential bleeding risks from the FDA, which is a critical consideration in its clinical use[4].

Emerging Therapies and Market Competition

The market for anticoagulants is evolving, with advancements in treatment research and the emergence of new therapies. XARELTO's position in this landscape will be influenced by these developments, as well as the competition posed by late-stage emerging therapies. The introduction of new treatments could impact XARELTO's market share, but its established clinical benefits and expanding indications are expected to maintain its relevance[4].

Geographical Market Dynamics

The global rivaroxaban market, including XARELTO, has significant potential in emerging economies. Regions like Asia Pacific and Latin America are experiencing rapid growth in demand for anticoagulants due to demographic changes and healthcare reforms. Market players are encouraged to invest in these regions through regional partnerships and acquisitions to access new customer segments and drive future growth[1].

Key Takeaways

• The global rivaroxaban market, driven by XARELTO, is projected to grow at a CAGR of 6.6% from 2024 to 2031.
• Growing prevalence of atrial fibrillation and venous thromboembolism, along with advantages over traditional anticoagulants, are key drivers.
• Emerging markets in Asia Pacific and Latin America offer significant opportunities.
• Patent expiry and the introduction of generic versions will impact pricing and market dynamics.
• XARELTO is expanding into new indications like PAD, which could boost its market presence.
• Financial performance will be influenced by FX headwinds, litigation payouts, and strategic adjustments.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of the global rivaroxaban market by 2031? A: The global rivaroxaban market is expected to reach USD 26.11 million by 2031[1].

Q: What are the primary drivers of the rivaroxaban market growth? A: The growing prevalence of atrial fibrillation and venous thromboembolism, advantages over traditional anticoagulants, and emerging market opportunities are key drivers[1].

Q: How will the patent expiry of XARELTO impact the market? A: The patent expiry will allow generic versions of rivaroxaban to enter the market, potentially reducing prices and impacting the revenues of major manufacturers[1].

Q: What new indications is XARELTO being explored for? A: XARELTO is being explored for the treatment of Peripheral Artery Disease (PAD)[4].

Q: How does the price of XARELTO compare globally? A: The price of XARELTO is significantly higher in the U.S. compared to other countries, with a price disparity of up to 10 times[3].

Sources:

1. Coherent Market Insights - Rivaroxaban Market - Share, Size and Industry Analysis
2. Bayer - Bayer aims to enhance performance and regain strategic flexibility by 2026
3. Healthcare Finance News - Price of two expensive drugs has cost Medicare Part D $46 billion
4. Business Wire - Market Expansion for XARELTO in Peripheral Artery Disease Treatment through 2032
5. Bayer - Bayer Q1 Media Update