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 Applications:	1,213
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

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

International Patents for edoxaban tosylate

Country	Patent Number	Title	Estimated Expiration
South Korea	100908966
Canada	2456841
South Korea	20040029322
Israel	159438	(CYCLOALKYL)ETHANEDIAMIDE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM

Supplementary Protection Certificates for edoxaban tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01405852/01	Switzerland		PRODUCT NAME: EDOXABAN; REGISTRATION NO/DATE: SWISSMEDIC 65149 31.03.2015
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

Edoxaban tosylate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Edoxaban Tosylate

Introduction to Edoxaban Tosylate

Edoxaban tosylate, a direct oral anticoagulant (DOAC), has been increasingly prominent in the treatment of conditions such as atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). This article delves into the market dynamics and financial trajectory of edoxaban tosylate, highlighting its current status, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The edoxaban tosylate API market has experienced a significant surge in recent years and is projected to continue this growth trend. According to market research, the market is expected to see sustained and substantial expansion from 2023 to 2031, driven by positive market dynamics and robust growth rates[1].

Segmentation of the Market

The edoxaban tosylate API market is segmented based on several key factors:

By Type

• Purity ≥ 98%: This segment is expected to dominate the market due to the high demand for high-purity APIs in pharmaceutical manufacturing.
• Purity < 98%: Although less dominant, this segment still holds significance for certain applications where lower purity is acceptable[1].

By Application

• Tablet: The primary application of edoxaban tosylate is in the form of tablets, which are widely used for anticoagulation therapy.
• Others: This includes other formulations and uses, such as injectables or research applications[1].

By Geography

• North America: A significant market due to advanced healthcare infrastructure and high demand for anticoagulants.
• Europe: Another major market with a large patient base and stringent regulatory standards.
• Asia-Pacific: Rapidly growing due to increasing healthcare spending and a large population.
• South America and Middle-East & Africa: Emerging markets with growing demand for anticoagulants[1].

Drivers of Market Growth

Several factors are driving the growth of the edoxaban tosylate market:

Increasing Prevalence of Atrial Fibrillation and VTE

The rising incidence of atrial fibrillation and venous thromboembolism (VTE) is a major driver. These conditions require effective anticoagulation therapy, and edoxaban tosylate is a preferred option due to its efficacy and safety profile[5].

Favorable Clinical Outcomes

Studies have shown that edoxaban tosylate is as effective as, if not more so than, traditional anticoagulants like warfarin. For instance, high-dose edoxaban has been found to be economically dominant compared to adjusted-dose warfarin in preventing stroke in patients with nonvalvular atrial fibrillation[2].

Convenience and Reduced Monitoring Needs

Edoxaban tosylate offers the advantage of reduced monitoring needs compared to warfarin, which requires regular blood tests. This convenience is a significant factor in its adoption by both patients and healthcare providers[3].

Financial Trajectory

Cost-Effectiveness

Edoxaban tosylate has been shown to be cost-effective in the long term. A study indicated that patients treated with high-dose edoxaban had lower lifetime treatment costs ($99,833) compared to those treated with adjusted-dose warfarin ($123,516), while also achieving higher quality-adjusted life-years (QALYs)[2].

Insurance Payments and Out-of-Pocket Costs

The financial burden of oral anticoagulants, including edoxaban tosylate, has been increasing. However, insurance payments have risen more significantly than out-of-pocket costs for patients. For example, average total insurance payments for any oral anticoagulant per patient increased from $434.8 to $1,025.7 from 2014 to 2021[3].

Market Revenue Projections

The market revenue for edoxaban tosylate API is expected to grow substantially. The market is valued in USD million and is forecasted to expand significantly from 2023 to 2031, driven by the increasing demand for anticoagulants and the favorable market dynamics[1].

Competitive Landscape

The edoxaban tosylate API market is characterized by a mix of established and emerging players. Key companies include:

• Morepen Laboratories Ltd
• Zydus Lifesciences Ltd
• Honour Lab Ltd
• MSN Life Sciences Private Ltd
• Zhejiang Supor Pharmaceuticals Co Ltd
• Shanghai Desano Chemical Pharmaceutical Co Ltd
• Simcere Pharmaceutical[1]

These companies are profiled in market reports, which include details such as their market entry year and various market-related factors.

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Strict regulatory standards and the need for continuous compliance can pose challenges for manufacturers.
• Competition from Other DOACs: The market is competitive, with other DOACs like apixaban and rivaroxaban also vying for market share[3].

Opportunities

• Growing Demand in Emerging Markets: The increasing healthcare spending in regions like Asia-Pacific presents significant growth opportunities.
• Research and Development: Continuous R&D can lead to new applications and formulations, expanding the market further[1].

Market Outlook

The market outlook for edoxaban tosylate is positive, with several growth catalysts and opportunities. Here are some key points:

Growth Catalysts

• Increasing Adoption: The convenience and efficacy of edoxaban tosylate are driving its adoption in clinical practice.
• Expanding Indications: Potential new indications and uses could further boost market growth[5].

Impediments

• Cost and Accessibility: High costs and varying insurance coverage can limit access to edoxaban tosylate for some patients.
• Side Effects and Safety Concerns: As with any anticoagulant, there are risks of bleeding and other side effects, which need to be managed[5].

Porter's 5 Forces Framework

• Threat of New Entrants: Moderate due to regulatory barriers and the need for significant investment in R&D.
• Bargaining Power of Suppliers: Low to moderate, as there are multiple suppliers of raw materials.
• Bargaining Power of Buyers: Moderate to high, as buyers (healthcare providers and patients) have some leverage due to the availability of alternative treatments[1].

Conclusion

The edoxaban tosylate API market is poised for significant growth, driven by its efficacy, convenience, and cost-effectiveness. Despite challenges such as regulatory hurdles and competition, the market is expected to expand substantially over the forecast period.

Key Takeaways

• Rapid Market Growth: The edoxaban tosylate API market is experiencing rapid growth and is projected to continue this trend.
• Cost-Effectiveness: Edoxaban tosylate is cost-effective compared to traditional anticoagulants.
• Increasing Adoption: The convenience and efficacy of edoxaban tosylate are driving its adoption.
• Competitive Landscape: The market is characterized by both established and emerging players.
• Growing Demand in Emerging Markets: Emerging markets offer significant growth opportunities.

FAQs

Q: What are the primary applications of edoxaban tosylate?

A: The primary applications of edoxaban tosylate are in the treatment of atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE), primarily in the form of tablets[5].

Q: How does edoxaban tosylate compare to warfarin in terms of cost-effectiveness?

A: Edoxaban tosylate has been shown to be more cost-effective than warfarin, with lower lifetime treatment costs and higher QALYs[2].

Q: What are the key drivers of the edoxaban tosylate market growth?

A: The key drivers include the increasing prevalence of atrial fibrillation and VTE, favorable clinical outcomes, and the convenience of reduced monitoring needs[5].

Q: Who are the major players in the edoxaban tosylate API market?

A: Major players include Morepen Laboratories Ltd, Zydus Lifesciences Ltd, Honour Lab Ltd, MSN Life Sciences Private Ltd, Zhejiang Supor Pharmaceuticals Co Ltd, Shanghai Desano Chemical Pharmaceutical Co Ltd, and Simcere Pharmaceutical[1].

Q: What are the potential challenges facing the edoxaban tosylate market?

A: Challenges include regulatory hurdles, competition from other DOACs, and concerns about cost and accessibility[1][3].

Sources

1. Market Research Intellect, "Global Edoxaban Tosylate API Market Size, Trends and Projections"[1].
2. PubMed, "Cost-Effectiveness of High-Dose Edoxaban Compared with Adjusted-Dose Warfarin in Patients with Nonvalvular Atrial Fibrillation"[2].
3. CDC Stacks, "Trends in Drug Spending of Oral Anticoagulants for Atrial Fibrillation"[3].
4. Market Research Reports, "Global Edoxaban Tosylate API Market 2023 by Manufacturers, Regions, Type and Application, Forecast to 2029"[4].
5. FDA, "Edoxaban Tosylate Tablet Clinical Pharmacology Review"[5].