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DEFERIPRONE

ANDA

DEFERIPRONE | A208800 | TARO PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FERRIPROX(TE code: AB)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cooley's Anemia Foundation (CAF) FDA-2020-P-0421 The Cooley's Anemia Foundation filed this citizen petition under 21 U.S.C. § 355(q) requesting that the FDA require all deferiprone products, including generic versions, to implement monitoring and patient support measures comparable to ApoPharma's current voluntary REMS program for Ferriprox to ens	505(q)	2020-01-27	Open	Cooley's Anemia Foundation (CAF)

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

Medicare Part D Spending

CMS annual spending data for Deferiprone (2023)

Total Spending

$7.5M

Total Claims

859

Beneficiaries

198

Avg Cost/Unit

$52.98

Spending Trend

$3.1M(2021)→$5.7M(2022)→$7.5M(2023)

YoY Change:-3.4%

5yr CAGR:-1.7%

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

API Supply Chain5 active DMFs1 inactive

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

APOTEX INCDEFERIPRONE

DMF 108671994

EMCURE PHARMACEUTICALS LTDDEFERIPRONE

DMF 216402008

TARO PHARMACEUTICAL INDUSTRIES LTDDEFERIPRONE

DMF 289832015

AARTI PHARMALABS LTDDEFERIPRONE

DMF 397662024

INDUSTRIALE CHIMICA SRLDEFERIPRONE

DMF 419162025

CADILA HEALTHCARE LTDInactiveDEFERIPRONE

DMF 149102000

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 12, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 8, 2019

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 22, 2023