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RADICAVA

NDA

EDARAVONE | N209176 | SHIONOGI INC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)NCT04259255	—	Completed	Shionogi	74	2019-10-21 → 2024-11-24

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

Medicare Part D Spending

CMS annual spending data for Radicava (2023)

Total Spending

$11.1M

Total Claims

868

Beneficiaries

104

Avg Cost/Unit

$6.39

Spending Trend

$67.6M(2019)→$66.9M(2020)→$64.9M(2021)→$45.0M(2022)→$11.1M(2023)

YoY Change:+3.0%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Radicava (2023)

Total Spending

$6.0M

Total Claims

4,005

Beneficiaries

ASP Price

—

HCPCS: J1301 — Injection, edaravone, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain13 active DMFs

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

DR REDDYS LABORATORIES LTDEDARAVONE

DMF 344492019

SOLARA ACTIVE PHARMA SCIENCES LTDEDARAVONE

DMF 345602020

MSN LABORATORIES PRIVATE LTDEDARAVONE

DMF 346622020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDEDARAVONE

DMF 347512020

QUIMICA SINTETICA SAEDARAVONE

DMF 347762020

GLAND PHARMA LTDEDARAVONE

DMF 350282020

NEULAND LABORATORIES LTDEDARAVONE

DMF 352042020

MEDICHEM MANUFACTURING (MALTA) LTDEDARAVONE

DMF 352112020

CIPLA LTDEDARAVONE

DMF 362442021

YUNG ZIP CHEMICAL IND CO LTDEDARAVONE

DMF 372412022

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDEDARAVONE NON-STERILE DRUG SUBSTANCE

DMF 402022024

INTERQUIM SAEDARAVONE

DMF 409102025

ZHEJIANG KINGLAND PHARMACEUTICAL CO LTDEDARAVONE

DMF 433242025

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2022	SUPPL -12	View Letter (PDF)
Mar 17, 2021	SUPPL -10	View Letter (PDF)
Nov 5, 2019	SUPPL -9	View Letter (PDF)
Jun 11, 2019	SUPPL -7	View Letter (PDF)
May 9, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 30MG/100ML (0.3MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 5, 2017

No patent or exclusivity listings for this strength.

#002 — 60MG/100ML (0.6MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 15, 2018