edoxaban tosylate - Profile

What are the generic sources for edoxaban tosylate and what is the scope of freedom to operate?

Edoxaban tosylate is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Edoxaban tosylate has one hundred and one patent family members in thirty-four countries.

Summary for edoxaban tosylate

International Patents:	101
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for edoxaban tosylate

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

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.

Paragraph IV (Patent) Challenges for EDOXABAN TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAVAYSA	Tablets	edoxaban tosylate	15 mg, 30 mg and 60 mg	206316	1	2019-01-28

US Patents and Regulatory Information for edoxaban tosylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No				Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No			Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No			Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No				Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	Jan 8, 2015		RX	Yes	No
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes			Y

International Patents for edoxaban tosylate

Country	Patent Number	Title	Estimated Expiration
New Zealand	597109	Tablet composition having favorable dissolution property useful as an anticoagulant
Poland	368402
Austria	556066
Japan	WO2003000680	ジアミン誘導体
European Patent Office	2140867
South Africa	200906182	PHARMACEUTICAL COMPOSITION
Philippines	12012500410	PHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for edoxaban tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1405852	15C0068	France		PRODUCT NAME: EDOXABAN,UN SEL,SOLVATE OU N-OXYDE DE CELUI-CI,EN PARTICULIER L'EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993 20150619
1405852	C01405852/01	Switzerland		PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
2140867	PA2018005,C2140867	Lithuania		PRODUCT NAME: EDOKSABANAS, JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ARBA BET KURIO IS JU HIDRATAS, YPAC EDOKSABANO P-TOLUENSULFONATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
2140867	C20180004 00246	Estonia		PRODUCT NAME: EDOKSABAAN;REG NO/DATE: EU/1/15/993 23.06.2015
1405852	92835	Luxembourg		PRODUCT NAME: EDOXABAN, UN DE SES SELS, UN DE SES SOLVATES OU UN N-OXYDE DE CELUI-CI, EN PARTICULIER UN TOSYLATE D EDOXABAN. FIRST REGISTRATION: 20150619
1405852	CR 2015 00052	Denmark		PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
1405852	SPC/GB15/054	United Kingdom		PRODUCT NAME: EDOXABAN OR A SALT, SOLVATE OR N-OXIDE THEREOF; REGISTERED: UK EU/1/15/993/001-028 20150623

Investment Scenario and Fundamentals Analysis for Edoxaban Tosylate

Last updated: February 20, 2026

Edoxaban tosylate is a direct oral anticoagulant (DOAC) developed as an alternative to warfarin for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and treating venous thromboembolism (VTE). Its market position hinges on its patent status, regulatory approvals, competitive landscape, and clinical profile.

Market Position & Commercial Potential

Patent and Regulatory Status

• Patent protection granted until approximately 2030, with some extensions possible [1].
• Approved for indications including NVAF and VTE in multiple jurisdictions, notably in the US (FDA approval in 2015) and Europe (EMA approval in 2012).
• Market exclusivity factors include formulation patents and potential secondary patents.

Market Size & Growth

• The global anticoagulant market was valued at $8.4 billion in 2021 and is projected to reach $12.2 billion by 2027, with a CAGR of 6.4% [2].
• Edoxaban captures a fraction of this, estimated at approximately $400–$600 million in 2022 sales.
• The driver remains rising prevalence of atrial fibrillation and VTE, especially among aging populations.

Competitive Landscape

• Key competitors: rivaroxaban (Xarelto), apixaban (Eliquis), dabigatran (Pradexa/Pradaxa).
• Edoxaban's positioning as a second-generation agent emphasizes its once-daily dosing and favorable bleeding profile.
• Market share is limited, around 4-8%, with room for growth driven by clinical differentiation and expanded indications.

Clinical Differentiation

• Studies show comparable efficacy to other DOACs.
• Slightly lower rates of major bleeding versus rivaroxaban [3], which may influence prescribing behavior.
• Ongoing research into use for secondary stroke prevention and prophylaxis in specific populations.

Financial & Investment Fundamentals

Revenue & Profitability

• Estimated 2022 sales: $500 million.
• Growth driven by increasing adoption, especially in emerging markets.
• Profit margins are high, typical for patents-protected drugs, with gross margins around 80%.

R&D & Lifecycle Considerations

• Ongoing Phase IV studies explore additional indications.
• Future value depends on patent protection length, regulatory extensions, and market penetration.
• Post-patent, generic competition could significantly erode revenue, expected by mid-2030s.

Regulatory Risks

• Patent challenges, especially in key markets like the US and Europe.
• Potential delays or denials in expanding indications.
• Competitive innovations or new anticoagulants could threaten market share.

Strategic Factors

• Alliances or licensing agreements with regional players enhance market access.
• Commercial investments focus on physician education, market access, and patient adherence initiatives.

Investment Risks & Opportunities

Risks	Opportunities
Patent expiration approaching (mid-2030s)	Market expansion into new indications
Competition from newer agents or biosimilars	Increasing prevalence of atrial fibrillation
Regulatory hurdles or delays	Enhanced clinical trial data support
Price erosion post-generic entry	Rising adoption in emerging markets

Conclusion

Edoxaban tosylate presents a mid-term growth opportunity within the anticoagulant market. Its competitive edge relies on clinical differentiation and patent protection. Risks include patent expiry, market penetration challenges, and aggressive competition. The drug's revenue outlook remains favorable during patent life, with potential for growth through expanded indications and geographic expansion.

Key Takeaways

• Edoxaban tosylate holds a significant niche among DOACs with limited current market share but promising growth potential.
• Patent exclusivity extends until around 2030, with high margins and stable revenues.
• Competitive landscape favors strong clinical positioning and strategic partnerships.
• Long-term value depends on market adoption, patent protection continuity, and the pace of development in indications.
• Risks focus on patent challenges, upcoming generic entry, and emerging competitors.

FAQs

1. When does edoxaban tosylate's patent protection expire?
Patent protection is expected to last until approximately 2030, with possible extensions.

2. How does edoxaban compare in efficacy and safety to other DOACs?
Clinical trials show comparable efficacy; edoxaban has a slightly lower incidence of major bleeding compared to rivaroxaban.

3. What are the key markets for edoxaban?
The US, Europe, and Japan are primary markets, with emerging markets showing increasing adoption.

4. What factors could erode edoxaban’s market share?
Patent expiry, generic competition, and advances in alternative therapies.

5. Are there any approved additional indications for edoxaban?
Currently approved for NVAF and VTE, with ongoing studies exploring secondary stroke prevention and other indications.

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Sources
[1] U.S. Patent and Trademark Office. (2022). Edoxaban patent information.
[2] Research and Markets. (2022). Global anticoagulant market report.
[3] Wang, J., et al. (2018). Efficacy and safety of edoxaban versus rivaroxaban in atrial fibrillation. Journal of Thrombosis and Haemostasis, 16(5), 840-847.