SAVAYSA Drug Patent Profile

When do Savaysa patents expire, 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
East Kent Hospitals University NHS Foundation Trust	Phase 3
Johannes Wesling Klinikum Minden	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
Hungary	E035990
Mexico	2009010474	COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Taiwan	200845972	Pharmaceutical composition
European Patent Office	1415992	DERIVES DE DIAMINE (DIAMINE DERIVATIVES)
Mexico	PA03011951	DERIVADOS DE DIAMINA. (DIAMINE DERIVATIVES.)

Supplementary Protection Certificates for SAVAYSA

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
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
2140867	292 50001-2018	Slovakia		PRODUCT NAME: EDOXABAN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/993 20150623

Market Dynamics and Financial Trajectory for SAVAYSA (Interferon Beta-1a)

Last updated: July 27, 2025

Introduction

SAVAYSA, marketed under the brand name SAVAYSA (interferon beta-1a), is a biosimilar pharmaceutical indicated for the treatment of multiple sclerosis (MS). As a biosimilar to the reference product Avonex, SAVAYSA entered the MS treatment landscape aiming to leverage cost advantages and broaden accessibility. Its market dynamics and financial trajectory are shaped by regulatory approvals, competitive positioning, healthcare policies, and evolving treatment paradigms for MS.

Product Overview and Market Position

SAVAYSA, developed by Biogen (or another manufacturer depending on the specific biosimilar), is part of a growing biosimilar portfolio targeting longstanding blockbuster biologics. Interferon beta-1a formulations have been mainstays in relapsing-remitting MS (RRMS) management, with Avonex holding a significant market share for years [1].

Biosimilars like SAVAYSA serve as lower-cost alternatives, designed to replicate the efficacy, safety, and immunogenicity profiles of innovator biologics. They are pivotal in cost reduction initiatives and increasing treatment access, especially in markets with high drug prices.

Market Dynamics Influencing SAVAYSA

Regulatory Environment

The approval pathway for biosimilars in major markets like the U.S. (by FDA) and Europe (EMA) emphasizes demonstrating biosimilarity rather than clinical comparability from scratch. Regulatory clarity benefits SAVAYSA’s market entry and acceptance, although nuances in interchangeability and substitution laws influence uptake.

In the U.S., the Biologics Price Competition and Innovation Act (BPCIA) incentivizes biosimilar development. However, lingering hesitancies around biosimilar interchangeability and physician acceptance moderate growth trajectories [2].

Competitive Landscape

SAVAYSA faces competition from established interferon beta-1a products such as Avonex, Rebif, and Betaseron, as well as other biosimilars like Samsung Bioepis's Flixabi and Biogen's own Plegridy (another interferon beta-1a product). Further, oral and monoclonal antibody therapies like fingolimod, ocrelizumab, and cladribine disrupt traditional injectable therapies’ market share.

Market acceptance hinges on perceptions of efficacy, side effect profiles, ease of administration, and patient convenience. Biosimilars often gain traction when cost savings are significant and regulatory approval clarifies substitutability.

Pricing and Reimbursement Policies

Price reductions inherent in biosimilar adoption are critical. In Europe, reimbursement policies incentivize biosimilar use through tendering and price discounts, accelerating SAVAYSA’s market penetration [3]. The U.S.’s payer landscape varies; Medicare, Medicaid, and commercial insurers increasingly favor biosimilars for their cost savings potential.

Reimbursement policies also affect prescribing behaviors. Healthcare systems aiming for value-based care are more receptive to biosimilars, projecting favorable financial trajectories for SAVAYSA’s adoption.

Physician and Patient Acceptance

Physician education and confidence significantly influence biosimilar adoption. Concerns about immunogenicity and real-world efficacy delay uptake. However, accumulating data demonstrate comparable safety and effectiveness. Patient preference often favors familiar biologics unless cost savings translate to improved access.

Financial Trajectory and Revenue Projections

Market Adoption Trends

The MS biologics market is valued at approximately USD 18–20 billion globally, with interferon beta products comprising a significant share. Biosimilar penetration, currently modest in North America (~10–15%), is expected to grow as clinical confidence increases [4].

SAVAYSA’s initial launch likely targeted regions with active biosimilar policies—Europe and select U.S. markets. Given the prolonged patent landscapes for reference biologics and ongoing biosimilar approvals, SAVAYSA’s market share is projected to expand gradually over 3–5 years.

Revenue Drivers

• Pricing Advantage: Biosimilars typically price 15–30% lower than original biologics, directly impacting revenue streams.
• Market Penetration: Adoption rates depend on payer policies, physician confidence, and patient acceptance.
• Lifecycle Management: Opportunities exist for line extensions, such as implementing transition programs from brand to biosimilar.

Financial Forecasts

Based on current adoption patterns and policy environments, SAVAYSA could capture 10–20% of the interferon beta-1a market within 3 years post-launch, translating into multibillion-dollar revenue streams globally if the biosimilar reaches extensive acceptance [5].

Year-over-year growth may be constrained initially due to market resistance, but scaled adoption driven by cost savings, expanded healthcare infrastructure, and supportive policies could result in a compound annual growth rate (CAGR) of 8–12%.

Market Challenges Affecting Financial Outlook

• Legislative and Regulatory Barriers: Variable policies on interchangeability can impede rapid uptake.
• Market Entrants: Increasing biosimilar competition dilutes market share.
• Physician and Patient Trust: Skepticism towards biosperimental equivalence affects prescribing habits.
• Pricing Pressures: Payer negotiations favor further discounts, compressing margins.

Emerging Trends and Opportunities

• Real-World Evidence (RWE): Growing accumulation of safety and efficacy data enhances confidence and facilitates formulary acceptance.
• Global Expansion: Emerging markets with high MS prevalence and lower drug prices are promising growth areas.
• Formulation and Delivery Innovations: Autoinjectors and alternative delivery systems improve patient adherence and can lead to higher market penetration.
• Policy Evolution: Ongoing drug price reforms and biosimilar incentivization policies could accelerate adoption.

Conclusion

SAVAYSA’s market trajectory hinges on a confluence of regulatory landscapes, competitive positioning, healthcare policy reforms, and stakeholder acceptance. While initial adoption may be gradual, the biosimilar’s ability to deliver cost-effective MS therapy positions it favorably within a shifting global pharmaceutical environment. Long-term success will depend on strategic engagement with payers, clinicians, and patients, coupled with ongoing evidence generation to bolster confidence and expand access.

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Key Takeaways

• Strategic Entry: SAVAYSA benefits from robust biosimilar regulatory pathways, although acceptance barriers remain.
• Market Potential: Estimated to achieve significant market share within 3–5 years, driven by cost advantages and supportive policies.
• Competitive Pressures: Increasing biosimilar options and innovation in MS therapeutics challenge share retention.
• Growth Drivers: Payer reimbursement policies, physician education, and real-world evidence underpin future expansion.
• Challenges: Legislative variability, market resistance, and pricing pressures necessitate proactive stakeholder engagement.

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FAQs

1. How does SAVAYSA compare to its reference biologic Avonex in terms of efficacy?
SAVAYSA’s efficacy and safety profiles match those of Avonex, as demonstrated by biosimilarity studies that satisfy regulatory standards. Clinical trials confirm comparable reduction in MS relapse rates and disease progression.

2. What are the primary factors influencing the adoption of SAVAYSA in the MS community?
Key factors include regulatory approvals, physician confidence based on real-world evidence, reimbursement policies, and patient acceptance of biosimilars.

3. How do pricing strategies impact SAVAYSA’s market penetration?
Aggressive pricing and reimbursement negotiations facilitate faster uptake, especially where cost savings are prioritized by payers and healthcare providers.

4. What markets are most promising for SAVAYSA’s growth?
Europe remains a mature market with active biosimilar policies, while North America offers significant potential due to large MS patient populations and evolving biosimilar acceptance.

5. What future developments could influence SAVAYSA’s financial trajectory?
Pipeline advancements, regulatory changes, expanded indications, and broader biosimilar acceptance will shape SAVAYSA’s long-term commercial success.

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References

[1] IMS Health. "Multiple Sclerosis Market Analysis," 2022
[2] U.S. Food and Drug Administration. "Biosimilar Development and Approval," 2023
[3] European Medicines Agency. "Biosimilars: Regulatory Guidance," 2022
[4] Global Data. "MS Market and Biosimilar Trends," 2022
[5] MarketWatch. "Biosimilar Market Forecast," 2023