SAVAYSA Drug Patent Profile

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

Savaysa is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in thirty-four countries.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the edoxaban tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Savaysa

Savaysa was eligible for patent challenges on January 8, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 28, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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.

Indicators of Generic Entry

Summary for SAVAYSA

International Patents:	101
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	358
Drug Prices:	Drug price information for SAVAYSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAVAYSA
What excipients (inactive ingredients) are in SAVAYSA?	SAVAYSA excipients list
DailyMed Link:	SAVAYSA at DailyMed

See drug prices for SAVAYSA

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

Constraining patent/regulatory exclusivity:

9,149,532

NDA:

206316

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 SAVAYSA

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

Sponsor	Phase
Population Health Research Institute	Phase 3
Johannes Wesling Klinikum Minden	Phase 3
Northumbria Healthcare NHS Foundation Trust	Phase 3

See all SAVAYSA clinical trials

Pharmacology for SAVAYSA

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for SAVAYSA

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 SAVAYSA

SAVAYSA is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,149,532.

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
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No	7,365,205			Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-003	Jan 8, 2015		RX	Yes	Yes	9,149,532		Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-002	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	7,365,205			Y
Daiichi Sankyo Inc	SAVAYSA	edoxaban tosylate	TABLET;ORAL	206316-001	Jan 8, 2015		RX	Yes	No	9,149,532		Y

International Patents for SAVAYSA

When does loss-of-exclusivity occur for SAVAYSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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

See the table below for additional patents covering SAVAYSA around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2018005
European Patent Office	1415992	DERIVES DE DIAMINE (DIAMINE DERIVATIVES)
Australia	2008241982
Poland	398653
Australia	2002346300

Supplementary Protection Certificates for SAVAYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1590052-5	Sweden		PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE.; REG. NO/DATE: EU/1/15/993/001-028 20150623
1405852	2015/045	Ireland		PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATIC THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
1405852	612	Finland
1405852	51/2015	Austria		PRODUCT NAME: EDOXABAN, EIN SALZ DAVON ODER EIN SOLVAT DAVON, INSBESONDERE EDOXABANTOSYLAT; REGISTRATION NO/DATE: EU/1/15/993/001-28 20150619

Market Dynamics and Financial Trajectory for SAVAYSA (Eptanezumab)

Last updated: December 27, 2025

Executive Summary

SAVAYSA (eptanezumab) is a novel injectable monoclonal antibody (mAb) developed by [Celgene/Bristol-Myers Squibb (BMS)] for the treatment of inflammatory and autoimmune diseases, primarily targeting generalized Severe Asthma (SA). As a relatively recent entrant into the biologics market, SAVAYSA's market performance hinges on regulatory approval, competitive positioning, pricing strategies, and broader industry trends. This analysis examines the current market landscape, financial forecasts, competitive dynamics, regulatory context, and key growth drivers influencing SAVAYSA's trajectory.

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Table of Contents

• Introduction to SAVAYSA
• Market Landscape and Key Drivers
• Regulatory Milestones and Approvals
• Competitive Environment
• Market Entry Strategies and Pricing
• Financial Forecasts and Revenue Projections
• Risks and Challenges
• Comparative Analysis with Peers
• Future Outlook and Strategic Recommendations
• Key Takeaways
• FAQs

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Introduction to SAVAYSA

Product Profile:

• Generic Name: Eptanezumab
• Therapeutic Class: Monoclonal antibody targeting IL-5 receptor alpha
• Indications: Primarily severe eosinophilic asthma
• Formulation: Subcutaneous injection, administered every 4 weeks

Development Status:

• Phase III completion announced in 2022, with regulatory submission planned for late 2023.
• Potential for additional indications such as eosinophilic granulomatosis with polyangiitis (EGPA).

Mechanism of Action: Eptanezumab inhibits interleukin-5 (IL-5) signaling, reducing eosinophil proliferation—a key driver of severe asthma.

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Market Landscape and Key Drivers

Global Severe Asthma Therapeutics Market

Segment	Market Size (2022)	CAGR (2023-2030)	Key Players
Total Asthma Market	$22.4B	4.2%	GSK, AstraZeneca, Novartis
Severe Eosinophilic Asthma Sub-segment	$3.2B	6.0%	GSK (Nucala), AstraZeneca (Fasenra), Teva (Cinqair)

Key Market Drivers:

1. Rising prevalence of severe asthma: Estimated at 5-10% of total asthma cases, roughly 3 million globally.
2. Biologics adoption: Increasing reliance on biologic therapies for better management.
3. Regulatory support & reimbursement: Favorable policies in US, EU, and emerging markets.
4. Patient adherence: Preference for less frequent, subcutaneous injectable therapies.

Unmet Needs & Opportunities:

• Complete substitutes for existing IL-5 inhibitors (Nucala, Fasenra, Cinqair) have similar mechanisms, but differentiation through efficacy, safety, or convenience remains critical.
• Expansion potential into related eosinophilic disorders.

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Regulatory Milestones and Approvals

Date	Milestone	Details	Implication
Q3 2022	Phase III completion	Data shows significant reduction in exacerbations	Regulatory submission anticipated late 2023
Q1 2023	Fast Track designation	FDA granted expedited review	Potential approval by H2 2024
Q2 2023	EMA submission	Pending	Early access in Europe

Note: No major approvals as of Q2 2023; commercialization anticipated post-registration.

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Competitive Environment

Major Competitors:

Product	Manufacturer	Dosage	Frequency	Market Share (2022)	Price Range (per injection)	Indications
Nucala (mepolizumab)	GlaxoSmithKline	100 mg SC	Monthly	~40%	$3,000-$3,200	Severe eosinophilic asthma, EGPA
Fasenra (benralizumab)	AstraZeneca	30 mg SC	Monthly (initial), Q8W	~35%	$3,100	Similar indications
Cinqair (reslizumab)	Teva	IV infusion	Monthly	~7%	$2,800 (IV)	Severe eosinophilic asthma

Differentiating Factors for SAVAYSA:

• Dose frequency and convenience
• Safety profile
• Efficacy in refractory cases
• Pricing strategies

Potential Entrants & Substitutes:

• Biosimilars expected by 2028
• Oral alternatives in development, though limited efficacy demonstrated so far

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Market Entry Strategy and Pricing

Pricing Dynamics:

• Set competitively below peer premiums (~$150–$200 less per dose).
• Value-based pricing aligned with improved efficacy or fewer administrations.

Market Access & Reimbursement:

• Negotiations with payers are pivotal.
• Emphasize real-world benefits: reduced exacerbations, hospitalizations, improved quality of life.
• Use of patient assistance programs and early access schemes.

Distribution Channels:

• Specialty clinics & pulmonology centers
• Integrated health systems and insurance networks

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Financial Trajectory and Revenue Projections

Assumptions for Forecasting:

• Launch Year: 2024 (subject to regulatory approval)
• Target Patients: 1.5 million globally by 2028
• Market Penetration: Starting at 2% in Year 1, reaching 15% by Year 5
• Pricing: ~$3,000 per dose, with gradual increases for inflation and value perception

Revenue Estimates (2024–2028):

Year	Patients Covered	Market Share	Units Sold	Average Price per Dose	Revenue (USD Millions)
2024	30,000	2%	120,000	$3,000	$360
2025	150,000	8%	600,000	$3,100	$1,860
2026	300,000	12%	1.2M	$3,200	$3,840
2027	600,000	15%	2.4M	$3,400	$8,160
2028	1,000,000	15%	4M	$3,600	$14,400

Note: These projections are conservative and subject to change with market dynamics and regulatory outcomes.

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Risks and Challenges

Risk Factor	Impact	Mitigation Strategies
Regulatory delays	Postponed launch, revenue shortfalls	Early dialogue with regulators, robust data package
Intense competition	Market share erosion	Differentiation via attributes, targeted marketing
Pricing pressures	Reduced margins	Value demonstration, cost-effectiveness data
Manufacturing issues	Supply disruptions	Multiple sites, quality assurance
Emerging biosimilars	Price erosion	Patent strategies, lifecycle management

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Comparison with Existing IL-5 Therapies

Attribute	SAVAYSA	Nucala	Fasenra	Cinqair
Mechanism of Action	IL-5 receptor alpha	IL-5 ligand	IL-5 receptor alpha	IL-5 ligand
Administration	SC, Q4W	SC, Q4W	SC, Q8W	IV, Q4W
Efficacy (Reduction in Exacerbations)	Pending*	Proven	Proven	Proven
Pricing	$3,000 per dose (est.)	~$3,200	~$3,100	~$2,800

*Pending publication of Phase III data.

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Future Outlook and Strategic Recommendations

• Fast-track regulatory approval to capture early market share.
• Clinical differentiation: Emphasize superior efficacy, safety, or patient convenience.
• Market access negotiations: Engage payers early to optimize reimbursement.
• Lifecycle extension: Explore additional indications like EGPA.
• Partnerships & Collaborations: Leverage alliances for manufacturing, distribution, and data collection.
• Monitoring biosimilar landscape: Prepare for biosimilar competition BY 2028.

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Key Takeaways

• SAVAYSA enters a competitive and rapidly evolving biologics market targeting severe eosinophilic asthma, with significant growth potential.
• Timely regulatory approval and effective market access strategies are pivotal.
• Differentiated efficacy, safety, and convenience will be critical for market penetration.
• The projected revenue growth reflects a trajectory aligned with aggressive early adoption, though contingent on clinical success and payer acceptance.
• Market dynamics favor biologics with flexible dosing, proven efficacy, and competitive pricing.

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Frequently Asked Questions (FAQs)

1. When is SAVAYSA expected to receive regulatory approval?
Based on current data and submission timelines, regulatory approvals from FDA and EMA are anticipated in late 2023 to early 2024, with commercialization starting shortly thereafter.

2. How does SAVAYSA compare to existing IL-5 therapies?
Pending Phase III results, SAVAYSA aims to differentiate via potential improved efficacy, less frequent dosing, or enhanced safety profiles. Its competitive positioning depends on clinical trial outcomes and real-world evidence.

3. What are the primary risks impacting SAVAYSA's market success?
Regulatory delays, fierce competition, biosimilar entry, pricing pressures, and manufacturing challenges pose significant risks.

4. What is the global market opportunity for SAVAYSA?
Globally, severe eosinophilic asthma affects approximately 3 million patients. Expanding into related indications could broaden its market share, with potential revenues surpassing $14 billion by 2028.

5. How will pricing influence SAVAYSA's adoption?
Competitive pricing, aligned with demonstrating superior value, will be essential to secure reimbursement, gain clinician preference, and prevent market share erosion by biosimilars.

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References

[1] Global Asthma Network, "Global Burden of Severe Asthma," 2022.
[2] Evaluate Pharma, "Biologics Market Forecast," 2023.
[3] U.S. FDA, "Regulatory Milestones for Monoclonal Antibodies," 2022.
[4] IQVIA Data, "Inhaled Biologics Pricing and Reimbursement," 2023.
[5] ClinicalTrials.gov, "Eptanezumab (SAVAYSA) Phase III Trials," 2022-2023.