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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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:	52
Clinical Trials:	11
Patent Applications:	378
Drug Prices:	Drug price information 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

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
Germans Trias i Pujol Hospital	Phase 3
Julius-Maximilians University	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.

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

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
Brazil	0210541
Israel	160204	DIAMINE DERIVATIVES, SALTS THEREOF AND SOLVATES AND N-OXIDES THEREOF WHICH EXIBIT POTENT FXa-INHIBITING EFFECT AND ANTICOAGULANT EFFECT
Lithuania	PA2018005
South Korea	20040029322

Supplementary Protection Certificates for SAVAYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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

Market Dynamics and Financial Trajectory for SAVAYSA (Edoxaban)

Introduction

SAVAYSA, known internationally as Lixiana, is an oral anticoagulant developed by Daiichi Sankyo, used primarily for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism. Here, we delve into the market dynamics and financial trajectory of SAVAYSA.

Market Opportunity and Dynamics

NOAC Market

SAVAYSA operates within the Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) market, which has seen significant growth due to its advantages over traditional anticoagulants like warfarin. The NOAC market is driven by the increasing prevalence of atrial fibrillation and venous thromboembolism, along with a preference for drugs with simpler dosing regimens and fewer drug interactions[4].

Competitive Landscape

The NOAC market is highly competitive, with other major players including apixaban (Eliquis), rivaroxaban (Xarelto), and dabigatran (Pradaxa). However, SAVAYSA has carved out a niche with its unique benefits, such as a once-daily dosing regimen and a reduced risk of major bleeding compared to warfarin[4].

Financial Performance

Revenue Growth

SAVAYSA has shown steady revenue growth over the years. In the FY2023 Q3 results, the global sales of edoxaban (including SAVAYSA) were reported at 277.3 billion JPY, up 15.5% from the previous year. Specifically, in the US, SAVAYSA sales were 2.0 billion JPY, a 4.6% increase year-over-year[1].

Regional Performance

• Japan: Lixiana, the Japanese brand name for edoxaban, has been a strong performer, with sales of 89.5 billion JPY in FY2023 Q3, representing a 12.6% increase from the previous year[1].
• Europe: Sales of Lixiana in Europe were 107.3 billion JPY, up 22.3% year-over-year[1].
• Asia, South and Central America: Sales in these regions also saw significant growth, with a 23.8% increase to 17.3 billion JPY[1].

Cost and Profit Margins

The cost of sales for Daiichi Sankyo's pharmaceuticals, including SAVAYSA, has been managed effectively. In FY2023 Q3, the cost of sales was 310.3 billion JPY, which is approximately 26.4% of the total revenue. This has contributed to a gross profit margin of 73.6%, indicating strong profitability[1].

Key Success Factors

Clinical Benefits

SAVAYSA's unique clinical benefits, such as its once-daily dosing and reduced bleeding risk, have been crucial in its market success. Clinical trials have demonstrated its efficacy and safety profile, making it a preferred choice for many clinicians[4].

Marketing and Distribution

Daiichi Sankyo's robust marketing and distribution strategies have played a significant role in expanding SAVAYSA's market share. The company's strong presence in Japan and its expanding reach in other regions have been key factors[3].

Regulatory Approvals

Regulatory approvals in various markets have been instrumental in SAVAYSA's growth. The drug has received approvals in multiple countries, including the US, Japan, and several European nations, which has helped in its global expansion[4].

Challenges and Future Outlook

Competitive Pressure

Despite its successes, SAVAYSA faces intense competition from other NOACs. The market is highly competitive, and maintaining market share will require continuous innovation and strong marketing efforts.

Patent Exclusivity

The loss of patent exclusivity in the future could impact SAVAYSA's revenue. However, Daiichi Sankyo is actively developing new products and expanding its pipeline to mitigate such risks[3].

Financial Trajectory

Operating Profit

The operating profit for Daiichi Sankyo, which includes the performance of SAVAYSA, has shown significant growth. In FY2023 Q3, the operating profit was 194.6 billion JPY, a 53.0% increase year-over-year[1].

Profit Before Tax

The profit before tax for the company also saw a substantial increase, reaching 199.8 billion JPY in FY2023 Q3, up 56.8% from the previous year[1].

Key Takeaways

• Market Growth: SAVAYSA has demonstrated steady revenue growth globally, driven by its unique clinical benefits and strong marketing efforts.
• Regional Performance: The drug has performed well in various regions, including Japan, Europe, and Asia.
• Profitability: SAVAYSA has contributed significantly to Daiichi Sankyo's profitability, with strong gross profit margins and operating profits.
• Challenges: The drug faces competitive pressure and potential future challenges related to patent exclusivity.

FAQs

What is SAVAYSA used for?

SAVAYSA (edoxaban) is used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism.

How does SAVAYSA compare to other NOACs?

SAVAYSA offers a once-daily dosing regimen and a reduced risk of major bleeding compared to warfarin, making it a preferred choice for many patients and clinicians.

What are the key regions for SAVAYSA's sales?

SAVAYSA generates significant revenue in Japan, Europe, and Asia, South and Central America.

How has SAVAYSA impacted Daiichi Sankyo's financial performance?

SAVAYSA has contributed to substantial revenue and profit growth for Daiichi Sankyo, with notable increases in operating profit and profit before tax.

What are the future challenges for SAVAYSA?

SAVAYSA faces intense competition from other NOACs and potential future challenges related to the loss of patent exclusivity.

Sources

1. Daiichi Sankyo - FY2023 Q3 Reference Data
2. Daiichi Sankyo - FY2022 Q2 Reference Data
3. Daiichi Sankyo Group Value Report 2017
4. SAVAYSA™ (edoxaban) U.S. Opportunity - Daiichi Sankyo

Last updated: 2024-12-16