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 May 13, 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-two 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 seven 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

^*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
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network	Phase 2/Phase 3
Ottawa Hospital Research Institute	Phase 2/Phase 3
Canadian Institutes of Health Research (CIHR)	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 9,415,053.

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	TABLET;ORAL	022406-001	Jul 1, 2011		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011		RX	Yes	Yes	9,415,053*PED
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No	7,157,456*PED
Janssen Pharms	XARELTO	rivaroxaban	FOR SUSPENSION;ORAL	215859-001	Dec 20, 2021		RX	Yes	Yes	7,157,456*PED

Expired US Patents for XARELTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011	7,592,339
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018	7,585,860
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011	7,585,860
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011	7,585,860
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	7,592,339

EU/EMA Drug Approvals for XARELTO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for XARELTO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2006208613	Prevention and treatment of thromboembolic disorders
Dominican Republic	P2000000114	OXAZOLIDINONAS SUBSTITUIDAS Y SU USO
Portugal	1526132
Spain	2300845
Spain	2542335
Taiwan	I277615

Supplementary Protection Certificates for XARELTO

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	C01261606/01	Switzerland		FORMER OWNER: BAYER SCHERING PHARMA AKTIENGESELLSCHAFT, DE
1261606	CA 2008 00050	Denmark		PRODUCT NAME: RIVAROXABAN OG DETS FARMACEUTISK ACCEPTABLE SALTE, HYDRATER, HYDRATER AF SALTENE OG PRODRUGS
1261606	PA2008018	Lithuania		PRODUCT NAME: RIVAROXABANUM; REG. NO/DATE: EU/1/07/472/001-008 20080930
1261606	PA2008018,C1261606	Lithuania		PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930
1261606	SPC/GB09/008	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/008 GRANTED TO BAYER INTELLECTUAL PROPERTY GMBH IN RESPECT OF THE PRODUCT RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6352 DATED 16 FEBRUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 OCTOBER 2023.

Market Dynamics and Financial Trajectory Analysis of Xarelto

The anticoagulant Xarelto (rivaroxaban), developed by Bayer and Johnson & Johnson, has been a cornerstone of Bayer’s pharmaceutical portfolio since its 2008 launch. However, shifting market dynamics—including generic competition, pricing pressures, and evolving therapeutic landscapes—are reshaping its financial trajectory. This report examines Xarelto’s historical performance, current challenges, and future prospects while contextualizing Bayer’s strategic responses to these headwinds.

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Historical Performance and Market Dominance

Rise to Blockbuster Status

Xarelto achieved rapid adoption as a novel oral anticoagulant (NOAC) due to its efficacy in preventing strokes in atrial fibrillation patients and treating venous thromboembolism. By 2017, U.S. sales peaked at $2.5 billion[4], supported by its advantages over warfarin, such as reduced monitoring requirements and a lower risk of dietary interactions. Global sales reached $4.1 billion in 2023[5], cementing its status as Bayer’s top-selling drug.

Patent Protections and Market Exclusivity

The drug’s initial success was bolstered by aggressive patent strategies. Bayer and Johnson & Johnson secured 49 patents for Xarelto, creating a "patent thicket" to delay generic competition[10]. This exclusivity allowed sustained pricing power, with U.S. prices reaching $553 per 30 pills compared to $112 in Canada[6]. However, these tactics extended market dominance at the cost of increased scrutiny over pricing practices[10].

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Current Market Challenges

Generic Erosion and Sales Decline

Xarelto’s sales fell 23.8% year-over-year in Q3 2024 to €802 million ($851 million)[1], driven by generic entrants in international markets. Analysts project a 15% annual decline in 2024[5], with 2025 sales expected to drop by €1–1.5 billion ($1.1–1.6 billion) due to EU patent rulings and at-risk generic launches[5]. In the U.S., Medicare’s Inflation Reduction Act (IRA) mandates price negotiations, potentially reducing Xarelto’s price by 62% ($320 annual savings per Medicare enrollee)[6].

"We will see a sales trough for either 2025 or 2026, with our next wave of growth following latest by 2027."
—Stefan Oelrich, Bayer Pharmaceuticals President[5]

Competitive Pressures from Eliquis

Bristol Myers Squibb and Pfizer’s Eliquis (apixaban) has overtaken Xarelto in market share (39% vs. 23%)[4], attributed to superior real-world bleeding profiles. A 321,000-patient French study showed Eliquis reduced intracranial and gastrointestinal bleeding risks by 35% compared to Xarelto[15], accelerating its adoption despite similar list prices.

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Strategic Responses by Bayer

Portfolio Diversification

Bayer is offsetting Xarelto’s decline with newer therapies:

• Nubeqa (darolutamide): Sales surged 83% in Q3 2024 to €1.08 billion ($1.1 billion annually), positioning it as Bayer’s third-largest drug[1]. Analysts forecast €1.3 billion ($1.4 billion) in 2024 sales[3], with peak projections exceeding €3 billion[3].
• Kerendia (finerenone): Chronic kidney disease treatment grew 96% in Q3 2024 to €126 million ($134 million)[1], with label expansions into heart failure underway[3].

Defensive Maneuvers for Legacy Products

Bayer is leveraging high-dose formulations and prefilled syringes for Eylea to delay biosimilar competition[1]. For Xarelto, tactics include:

• Geographic Shifts: Prioritizing markets with delayed generic entry, such as Japan and emerging economies[7].
• Pricing Adjustments: Aligning with IRA negotiations to maintain Medicare formulary positioning[9].

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Future Market Dynamics

Emerging Therapeutic Threats

Factor XIa inhibitors, like Bayer’s asundexian and Bristol Myers’ milvexian, threaten to disrupt the NOAC market. These drugs target clotting mechanisms with lower bleeding risks, potentially capturing €5+ billion ($5.4 billion) annually by 2030[12]. Bayer anticipates asundexian’s Phase III atrial fibrillation data by late 2025[12], which could expedite Xarelto’s obsolescence.

Patent Cliff and Generic Saturation

Xarelto’s U.S. patent expires in May 2025[13], with generics projected to capture 80% of the market within two years[6]. Medicare spending on Xarelto could decline by $595 million annually post-generic entry[13], compounding Bayer’s revenue challenges.

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Financial Projections and Strategic Implications

Revenue Contraction and Margin Pressures

Bayer’s pharmaceutical division forecasts flat growth through 2026[5], with Xarelto’s EBITDA contribution declining from €4.7 billion in 2023[14] to €3.5 billion by 2025[5]. Gross margins face dual pressures:

1. Generics: Average price erosion of 30–40% per annum in impacted markets[6].
2. R&D Investments: Bayer allocated €2.3 billion to cell/gene therapy and chemoproteomics in 2024[14], critical for long-term pipeline viability.

Regional Market Fragmentation

Sales trajectories diverge regionally:

• North America: 19% Q4 2024 sales decline due to IRA and generic competition[5].
• Asia-Pacific: 8% growth in 2024, driven by delayed generics in Japan[7].
• Europe: 12% decline from EU reference pricing and volume-based tenders[8].

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Conclusion

Xarelto’s financial trajectory underscores the volatility inherent in blockbuster pharmaceuticals facing patent expiries. Bayer’s strategic pivot to Nubeqa and Kerendia provides near-term revenue stabilization, but long-term success hinges on navigating Factor XIa inhibitors’ disruptive potential and Medicare pricing reforms. With anticoagulant innovation accelerating, Bayer must balance portfolio diversification with cost containment to avoid overreliance on legacy assets. The coming 24–36 months will prove decisive in determining whether Bayer’s transition from Xarelto-centric growth sustains its pharmaceutical division’s competitiveness.

References

1. https://www.fiercepharma.com/pharma/bayers-rising-prostate-cancer-star-nubeqa-crosses-blockbuster-barrier-xarelto-continues
2. https://www.bayer.com/sites/default/files/2021-08/bayer-ag-half-year-financial-report-q2-2021.pdf
3. https://www.fiercepharma.com/pharma/bayer-looks-ahead-nubeqa-kerendia-expansions-amid-xareltos-downward-sales-spiral
4. https://www.biopharmadive.com/news/competition-and-doughnut-hole-discount-takes-toll-on-xarelto-sales/553269/
5. https://www.fiercepharma.com/pharma/bayer-projects-xareltos-sales-decline-pick-steam-2025
6. https://www.drugpatentwatch.com/p/drug-price/drugname/XARELTO
7. https://www.globaldata.com/data-insights/healthcare/the-global-drug-sales-of-xarelto-1127441/
8. https://www.bayer.com/media/en-us/2024-q1-bayer-q1-media-update/
9. https://www.mmitnetwork.com/aishealth/radar-on-drug-benefits/icer-report-on-eliquis-xarelto-may-aid-drug-price-negotiations/
10. https://www.patientsforaffordabledrugs.org/wp-content/uploads/2022/04/Eliquis-and-Xarelto-report.pdf
11. https://www.cognitivemarketresearch.com/xarelto-market-report
12. https://www.biopharmadive.com/news/bristol-myers-bayer-factor-xia-inhibitors-sales-forecast/640155/
13. https://www.citizen.org/article/using-the-inflation-reduction-act-to-rein-in-patenting-evergreening-abuses/
14. https://www.bayer.com/media/en-us/bayer-meets-adjusted-guidance-and-takes-decisive-action-to-tackle-challenges/
15. https://www.fiercepharma.com/pharma/esc-pfizer-bms-eliquis-cuts-site-specific-bleeding-over-vkas-xarelto-french-real-world-study