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 April 18, 2027. 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:	405
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:

7,365,205

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
Cambridge University Hospitals NHS Foundation Trust	Phase 3
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	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 7,365,205.

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

International Patents for SAVAYSA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20040029322
Russian Federation	2314303	ПРОИЗВОДНЫЕ ДИАМИНА (DIAMINE DERIVATIVES)
Canada	2456841
Japan	WO2008129846
Lithuania	PA2018005
European Patent Office	1415992	DERIVES DE DIAMINE (DIAMINE DERIVATIVES)
Russian Federation	2319699	ПРОИЗВОДНЫЕ ДИАМИНОВ (DERIVATIVES OF DIAMINES)

Supplementary Protection Certificates for SAVAYSA

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
1405852	132016000024022	Italy		PRODUCT NAME: EDOXABAN, UN SUO SALE, UN SUO SOLVATO O UN SUO N-OSSIDO, IN PARTICOLARE EDOXABAN TOSILATO(LIXIANA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/993/001-028, 20150623
1405852	612	Finland
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	CA 2015 00052	Denmark		PRODUCT NAME: EDOXABAN, HERUNDER EDOXABAN TOSILATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
2140867	PA2018005	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
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

SAVAYSA (Olaparib) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SAVAYSA, known generically as olaparib, is a poly (ADP-ribose) polymerase (PARP) inhibitor developed by AstraZeneca. Its market performance is driven by approvals for multiple oncology indications, including ovarian, breast, pancreatic, and prostate cancers.

What is the current global market size for olaparib?

The global market for olaparib is estimated to be approximately USD 2.5 billion as of 2023. This valuation is based on reported sales and projected growth rates across its approved indications. Key revenue drivers include its use in maintenance therapy for platinum-sensitive recurrent ovarian cancer and for metastatic castration-resistant prostate cancer (mCRPC) with specific BRCA mutations. The market is segmented by indication and by region, with North America and Europe representing the largest markets due to higher healthcare spending and established regulatory frameworks.

What are the key therapeutic indications for SAVAYSA?

SAVAYSA is approved for the following primary indications:

• Ovarian Cancer: Used as maintenance treatment for adult patients with recurrent advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. This indication is a significant contributor to its market share.
• Breast Cancer: Approved for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer who have previously received chemotherapy in the neoadjuvant,