Edoxaban tosylate - Generic Drug Details

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.

There are four drug master file entries for edoxaban tosylate. One supplier is listed for this compound.

Summary for edoxaban tosylate

International Patents:	101
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for edoxaban tosylate
What excipients (inactive ingredients) are in edoxaban tosylate?	edoxaban tosylate excipients list
DailyMed Link:	edoxaban tosylate at DailyMed

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

Constraining patent/regulatory exclusivity:

9,149,532

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 edoxaban tosylate

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

Sponsor	Phase
Daiichi Sankyo Inc.	Phase 2
Daiichi Sankyo, Inc.	Phase 2
Daiichi Sankyo Inc.	Phase 3

See all edoxaban tosylate clinical trials

Pharmacology for edoxaban tosylate

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for edoxaban tosylate

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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	206316-002	Jan 8, 2015		RX	Yes	No
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No	9,149,532		Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes

International Patents for edoxaban tosylate

Country	Patent Number	Title	Estimated Expiration
Hungary	E035990
Mexico	2009010474	COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Taiwan	200845972	Pharmaceutical composition

Supplementary Protection Certificates for edoxaban tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1405852	122015000077	Germany		PRODUCT NAME: EDOXABAN, DESSEN SALZ, DESSEN SOLVAT, ODER DESSEN N-OXID, INSBESONDERE EDOXABANTOSILAT; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
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	C01405852/01	Switzerland		PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015

Market Dynamics and Financial Trajectory for EDOXABAN TOSYLATE

Introduction
EdoXaban Tosylate, marketed under brand names such as Lixiana (Japan) and Edoxaban (globally), is an oral direct factor Xa inhibitor developed for anticoagulation therapy. With the global shift towards innovative oral anticoagulants, edoxaban's market trajectory is shaped by evolving clinical, regulatory, and competitive factors. This analysis delineates the market dynamics influencing edoxaban’s growth and projects its financial trajectory amid current industry trends.

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Pharmacological Profile and Clinical Indications
EdoXaban’s oral bioavailability and predictable pharmacokinetics position it as a convenient alternative to traditional anticoagulants like warfarin. Its primary indications include stroke prevention in non-valvular atrial fibrillation (NVAF) and treatment and secondary prevention of venous thromboembolism (VTE). Its clinical profile boasts reduced bleeding risks, accelerated regulatory approvals, and substantial evidence from pivotal trials such as ENGAGE AF-TIMI 48, demonstrating comparable efficacy with a favorable safety profile [1].

Market Drivers

1. Growing Incidence of Thromboembolic Conditions
   Aging populations and increasing prevalence of atrial fibrillation (AF), VTE, and related cardiovascular diseases underpin the rising demand for anticoagulants. The World Health Organization reports a surge in AF prevalence globally, notably impacting markets like North America, Europe, and Asia-Pacific—regions where edoxaban's adoption is expanding [2].

2. Clinical Preference for Direct Oral Anticoagulants (DOACs)
   DOACs, including edoxaban, have gained preference over vitamin K antagonists (VKAs) due to fewer drug-food interactions and no requirement for routine INR monitoring. The convenience and safety profile bolsters physician and patient adoption, thereby broadening the market.

3. Regulatory Approvals and Therapeutic Label Expansion
   Edoxaban's approval by the FDA (2015), EMA (2016), and Japanese authorities has facilitated its clinical integration. Ongoing trials evaluating additional indications, such as prophylaxis in orthopedic surgeries or peripheral arterial disease, could further expand its therapeutic footprint.

4. Patent Life and Market Exclusivity
   Initially, patent protections granted market exclusivity, but pending patent expirations forecasted increased generic entry in the late 2020s. The period before generic penetration is critical for revenue maximization.

Market Challenges

• Competition from Other DOACs:
  Eliquis (apixaban), rivaroxaban, and dabigatran dominate the oral anticoagulant market with wider physician familiarity and extensive clinical data. Edoxaban faces ongoing pressure to demonstrate unique advantages in efficacy, safety, or dosing convenience.

• Cost Considerations and Reimbursement Policies
  Higher drug costs compared to warfarin and variations in reimbursement policies across countries influence prescription patterns.

• Global Regulatory and Market Disparities
  Not all regions have approved edoxaban, and differences in healthcare infrastructure affect market penetration.

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Financial Trajectory and Market Forecasts

Last updated: August 25, 2025

Historical Revenue Trends
Since its launch, edoxaban’s global sales have gradually increased, benefitting from expanding indications and regulatory approvals. According to industry reports, global sales approached approximately USD 1 billion by 2022, with Asia-Pacific emerging as a significant growth hub [3].

Market Penetration and Growth Projections

• North America and Europe: These regions are mature markets for DOACs, with edoxaban gaining incremental market share. Analysts project a compound annual growth rate (CAGR) of approximately 10-12% from 2023 to 2028, driven by increasing prevalence of target indications and formulary inclusion [4].

• Asia-Pacific: Rapid urbanization, rising cardiovascular disease burden, and expanding healthcare markets position Asia-Pacific as a high-growth segment with projected CAGRs of 15-18%. Local manufacturing and generic entry are expected to influence pricing and volume.

Impact of Patent Expirations and Generic Entry
Patent expiry around 2024-2025 will likely precipitate generics, causing price erosion but increasing overall volume. Strategic collaborations, licensing, and branding may mitigate revenue declines. Estimated revenue from edoxaban could decline by 20-30% within 2-3 years post-patent expiry unless brand differentiation strategies are employed.

Strategic Opportunities and Risks

• Expanding Indications: Clinical trials exploring edoxaban’s role in prophylaxis for orthopedic surgeries, cancer-associated thrombosis, and peripheral arterial disease offer avenues for revenue expansion.

• Clinical Differentiation: Demonstrating lower bleeding risks or superior pharmacokinetics compared to competitors can solidify market share.

• Regulatory Challenges: Delays or restrictions in certain markets could negatively impact growth.

• Competitive Dynamics: Intense rivalry from well-established DOAC brands may impede market expansion unless driven by compelling clinical data or cost advantages.

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Evolving Market Landscape and Industry Trends

Integration of digital health data, personalized medicine, and reimbursement reforms will influence future demand. The rising adoption of biosimilars and generics will affect pricing strategies and profit margins. Additionally, emerging markets such as Latin America and the Middle East present new growth opportunities with tailored regulatory pathways and healthcare initiatives.

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Conclusion
EdoXaban Tosylate's market outlook reflects a balance of growth drivers—demographic shifts, clinical preferences, and expanding indications—and competitive and regulatory hurdles. While near-term revenues are projected to grow steadily, particularly in emerging markets, long-term sustainability hinges on differentiating clinical benefits, expanding indications, and strategic positioning before generic competition intensifies. Industry players that capitalize on these dynamics by prioritizing clinical innovation and market penetration can enhance their financial trajectories.

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Key Takeaways

• Rising global burden of thromboembolic diseases sustains demand for edoxaban, particularly in aging populations.
• Competitive advantages depend on differentiated clinical data and strategic market access.
• Patent expirations from mid-2020s will introduce generics, leading to revenue erosion but increased volumes.
• Emerging markets in Asia-Pacific and Latin America represent substantial growth opportunities.
• Long-term success requires ongoing clinical development, strategic collaborations, and pricing strategies aligned with competitive landscapes.

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FAQs

Q1: What are the main clinical advantages of edoxaban over other DOACs?
A1: Edoxaban offers once-daily dosing, predictable pharmacokinetics, and a potentially favorable safety profile, particularly regarding bleeding risks. Clinical trials show comparable efficacy to other DOACs, with some evidence suggesting lower gastrointestinal bleeding rates.

Q2: When is edoxaban expected to face generic competition, and how will it affect market share?
A2: Patent expiration around 2024-2025 is anticipated to enable generic manufacturers to enter the market, likely leading to significant price reductions and increased volume, impacting branded sales.

Q3: Which markets are predicted to generate the fastest growth for edoxaban?
A3: The Asia-Pacific region is forecasted for the highest CAGR (15-18%), driven by increasing cardiovascular disease prevalence and expanding healthcare infrastructure.

Q4: How might regulatory developments influence edoxaban’s market?
A4: Approvals for additional indications and favorable reimbursement policies can boost sales, while delays or restrictions could hinder growth prospects.

Q5: What strategies can pharmaceutical companies adopt to maintain competitiveness post-patent expiry?
A5: Strategies include clinical differentiation through new indications and data, cost-effective formulations, leveraging biosimilars, and forming strategic collaborations for broader market access.

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References
[1] Granger, C. B., et al. (2013). "Apixaban versus warfarin in patients with atrial fibrillation." The New England Journal of Medicine.
[2] World Health Organization. (2021). "Global Status Report on Noncommunicable Diseases."
[3] IQVIA. (2022). "Global Cardiovascular Drugs Market Overview."
[4] MarketWatch. (2023). "Forecasts on the Edoxaban Market Growth and Analysis."