Viewing data from:

CLARISCAN

ANDA

GADOTERATE MEGLUMINE | A210016 | GE HEALTHCARE

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DOTAREM(TE code: AP)

Medicare Part B Spending

CMS physician-administered drug spending for Clariscan (2023)

Total Spending

$6.9M

Total Claims

331,147

Beneficiaries

293,436

ASP Price

—

HCPCS: A9575 — Injection, gadoterate meglumine, 0.1 ml

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

API Supply Chain7 active DMFs2 inactive

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

FORMOSA LABORATORIES INCGADOTERATE MEGLUMINE

DMF 341292019

INNOPHARMAX INCGADOTERATE MEGLUMINE

DMF 342912019

JIANGSU HENGRUI PHARMACEUTICALS CO LTDGADOTERATE MEGLUMINE

DMF 346732020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDGADOTERATE MEGLUMINE

DMF 361482021

ANHUI POLY PHARM CO LTDGADOTERATE MEGLUMINE

DMF 370722022

VIWIT PHARMACEUTICAL CO LTDGADOTERATE MEGLUMINE

DMF 387392023

BEIJING BEILU PHARMACEUTICAL CO LTDGADOTERATE MEGLUMINE

DMF 409352024

VIWIT PHARMACEUTICAL CO LTDInactiveGADOTERATE MEGLUMINE (DRUG SUBSTANCE)

DMF 344212020

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveGADOTERATE MEGLUMINE

DMF 394892024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 4, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 3.769GM/10ML (376.9MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 1, 2019

No patent or exclusivity listings for this strength.

#002 — 5.6535GM/15ML (376.9MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 1, 2019

#003 — 7.538GM/20ML (376.9MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 1, 2019

#004 — 37.69GM/100ML (376.9MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 4, 2020

#005 — 1.8845GM/5ML (376.9MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 24, 2020