Viewing data from:

SAVAYSA

NDA

EDOXABAN TOSYLATE | N206316 | DAIICHI SANKYO INC

3 strengths2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (1)TodayExclusivity

2027

2028

Today

7365205

Apr. 18, 2027

9149532

Mar. 28, 2028

M-14

Oct. 18, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

48 trials from ClinicalTrials.gov — 3 recruiting, 3 active, 32 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation NCT03129490	Phase 4	Active	Herlev and Gentofte Hospital	11,000	2023-04-01 → 2027-10-30
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)NCT03129555	Phase 4	Active	Herlev and Gentofte Hospital	5,000	2023-04-01 → 2029-03-31
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure NCT03568890	Phase 4	Active	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	510	2018-09-01 → 2030-09-01
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial NCT04284839	Phase 3	Recruiting	Population Health Research Institute	3,500	2021-07-18 → 2027-06
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation NCT03642509	N/A	Recruiting	University of Aarhus	750	2019-01-01 → 2030-10-01
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress NCT03968393	Phase 4	Recruiting	Population Health Research Institute	2,270	2019-06-14 → 2028-12
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty NCT01203098	Phase 2	Completed	Daiichi Sankyo Co., Ltd.	264	2008-07 → 2009-06
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty NCT01203072	Phase 2	Completed	Daiichi Sankyo Co., Ltd.	523	2006-07 → 2008-07
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation NCT00781391	Phase 3	Completed	Daiichi Sankyo	21,105	2008-11 → 2013-05
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer NCT02744092	N/A	Completed	Alliance Foundation Trials, LLC.	811	2016-12-13 → 2021-02-22

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$15.51

per ea

Lowest NADAC/Unit

$15.48

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65597020330SAVAYSA 60 MG TABLET	$15.51	EA	Brand	—	2026-07-01
65597020230SAVAYSA 30 MG TABLET	$15.48	EA	Brand	—	2026-07-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$304.45

Highest Price

$309.08

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
65597-0202-30SAVAYSA 30MG TAB	$309.08	FSS	Daiichi Sankyo, Inc.	09/30/2026
65597-0202-30SAVAYSA 30MG TAB	$304.45	Big4	Daiichi Sankyo, Inc.	09/30/2026
65597-0201-30SAVAYSA 15MG TAB	$309.08	FSS	Daiichi Sankyo, Inc.	09/30/2026
65597-0201-30SAVAYSA 15MG TAB	$309.08	Big4	Daiichi Sankyo, Inc.	09/30/2026
65597-0203-30SAVAYSA 60MG TAB	$309.08	FSS	Daiichi Sankyo, Inc.	09/30/2026
65597-0203-30SAVAYSA 60MG TAB	$304.85	Big4	Daiichi Sankyo, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Savaysa (2024)

Total Spending

$5.1M

Total Claims

7,868

Beneficiaries

1,536

Avg Cost/Unit

$13.81

Spending Trend

$8.4M(2019)→$7.8M(2020)→$6.7M(2021)→$5.8M(2022)→$5.3M(2023)→$5.1M(2024)

YoY Change:+0.9%

5yr CAGR:+1.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain21 active DMFs

21 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDEDOXABAN TOSYLATE (MONOHYDRATE)

DMF 323302017

HONOUR LAB LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 324012018

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDEDOXABAN TOSYLATE

DMF 329632018

ZYDUS LIFESCIENCES LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 331332018

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 360622021

MOREPEN LABORATORIES LTDEDOXABAN TOSYLATE

DMF 360842021

METROCHEM API PRIVATE LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 378962022

AMI LIFESCIENCES PRIVATE LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 382012023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 390742023

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDEDOXABAN (TOSYLATE MONOHYDRATE)

DMF 400402024

HIKAL LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 405292024

SAPTAGIR LABORATORIES PRIVATE LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 406952024

MEGAFINE PHARMA P LTDEDOXABAN TOSYLATE MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)

DMF 408322024

OPTIMUS DRUGS PRIVATE LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 412882025

VIYASH LIFE SCIENCES PRIVATE LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 413602026

PIRAMAL PHARMA LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 415212025

DR REDDYS LABORATORIES LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 420612025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDEDOXABAN TOSYLATE

DMF 421992025

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)EDOXABAN TOSYLATE MONOHYDRATE

DMF 422812025

BIOCON LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 434812026

NEULAND LABORATORIES LTDEDOXABAN TOSYLATE MONOHYDRATE

DMF 439052026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Oct 19, 2023	SUPPL -19	View Letter (PDF)
Sep 12, 2023	SUPPL -20	View Letter (PDF)
Nov 2, 2021	SUPPL -18	View Letter (PDF)
Apr 22, 2021	SUPPL -17	View Letter (PDF)
Apr 22, 2020	SUPPL -16	View Letter (PDF)
Aug 13, 2019	SUPPL -15	View Letter (PDF)
Oct 2, 2017	SUPPL -12	View Letter (PDF)
Sep 19, 2016	SUPPL -4	View Letter (PDF)
Sep 14, 2015	SUPPL -2	View Letter (PDF)
Jan 9, 2015	ORIG -1	View Letter (PDF)
Jan 9, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 15MG BASE

RLD

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Jan 8, 2015

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7365205	Apr 18, 2027	—	Yes	—	—	—
9149532	Mar 28, 2028	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-14	Oct 18, 2026	< 1 year

#002 — EQ 30MG BASE

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 8, 2015

#003 — EQ 60MG BASE

RLD

2 patents1 exclusivity▾

TABLET;ORAL | Approved: Jan 8, 2015