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CLARISCAN

ANDA

GADOTERATE MEGLUMINE | A210016 | GE HEALTHCARE

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DOTAREM(TE code: AP)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 Orange Book Product Listing Dotarem re Suitability Petition from... FDA-2017-P-4249 · 6 docket documents GE Healthcare Inc filed a citizen petition requesting that the FDA update the Orange Book product listing for Dotarem (gadoterate meglumine) to reflect suitability for pediatric magnetic resonance imaging applications, based on new clinical data demonstrating safety and efficacy in the pediatric pop	Suitability	2017-07-14	Withdrawn	GE Healthcare Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (8 FSS)

Lowest Price

$85.01

Highest Price

$850.00

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00407-2943-01CLARISCAN 0.5MMOL/ML INJ,SOLN	$85.01	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-02CLARISCAN 0.5MMOL/ML INJ,SOLN	$127.50	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-05CLARISCAN 0.5MMOL/ML INJ,SOLN	$170.00	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-06CLARISCAN 0.5MMOL/ML INJ,SOLN	$85.01	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-12CLARISCAN 0.5MMOL/ML INJ,PFS	$170.00	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-17CLARISCAN 0.5MMOL/ML INJ,PFS	$202.50	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-22CLARISCAN 0.5MMOL/ML INJ,PFS	$240.00	FSS	GE Healthcare Inc.	09/14/2030
00407-2943-70CLARISCAN 0.5MMOL/ML INJ,PFS	$850.00	FSS	GE Healthcare Inc.	09/14/2030

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

Medicare Part B Spending

CMS physician-administered drug spending for Clariscan (2024)

Total Spending

$6.6M

Total Claims

361,447

Beneficiaries

320,075

ASP Price

$0.12

Spending Trend

$6.4M(2019)→$5.3M(2020)→$6.1M(2021)→$6.0M(2022)→$6.9M(2023)→$6.6M(2024)

YoY Change:-13.8%

5yr CAGR:-9.6%

HCPCS: A9575 — Injection, gadoterate meglumine, 0.1 ml

Source: CMS Medicare Part B Spending by Drug (2024). 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