Viewing data from:

FERRIPROX

NDA

DEFERIPRONE | N021825 | CHIESI USA INC

2 strengths0 unique patents3 unique exclusivities

Patent Timeline

0 unique patents, 3 exclusivities by expiration date

TodayExclusivity

2027

2028

Today

ODE-417

Apr. 30, 2028

ODE-420

Apr. 30, 2028

ODE-421

Apr. 30, 2028

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Chiesi USA, Inc. et al v. Hikma Pharmaceuticals USA, Inc. 1:2020cv00484	D. Del.	2020-04-08	Terminated 2020-09-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cooley's Anemia Foundation (CAF) FDA-2020-P-0421 · 4 docket documents 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	Denied	Cooley's Anemia Foundation (CAF)

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

Clinical Trials

51 trials from ClinicalTrials.gov — 1 recruiting, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ferritin and Iron Burden in SAH sIRB NCT03754725	Phase 1/2	Recruiting	Duke University	66	2020-10-01 → 2026-12-31
Compassionate Use of Deferiprone for Patients With Thalassemia and Iron-Induced Heart Disease NCT00293098	—	APPROVED_FOR_MARKETING	Children's Hospital of Philadelphia	—	2006-03
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major NCT00800761	Phase 4	Completed	Ospedale Microcitemico	—	2001-12 → 2006-06
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients NCT01597765	N/A	Completed	Mahidol University	60	2009-06 → 2011-06
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers NCT02189941	Phase 1	Completed	ApoPharma	11	2014-05 → 2014-06
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment NCT01770652	Phase 4	Completed	ApoPharma	32	2013-01 → 2013-08
Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients NCT00349453	Phase 2	Completed	Lipomed	24	2005-03 → 2011-05
Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects NCT01860703	Phase 4	Completed	ApoPharma	50	2012-11 → 2013-07
Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients NCT00529152	Phase 3	Completed	ApoPharma	100	2007-08 → 2008-07
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers NCT01767103	Phase 4	Completed	ApoPharma	21	2013-01 → 2014-04

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$5656.60

Highest Price

$5656.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
10122-0103-05FERRIPROX 1000MG TAB,ORAL	$5656.60	FSS	Chiesi USA, 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 Ferriprox (2024)

Total Spending

$3.6M

Total Claims

267

Beneficiaries

Avg Cost/Unit

$59.94

Spending Trend

$775K(2021)→$3.8M(2022)→$3.7M(2023)→$3.6M(2024)

YoY Change:-8.1%

5yr CAGR:+2.2%

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

8 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	SUPPL -12	View Letter (PDF)
Nov 30, 2021	SUPPL -10	View Letter (PDF)
May 4, 2021	SUPPL -8	View Letter (PDF)
Feb 21, 2020	SUPPL -7	View Letter (PDF)
Jul 26, 2019	SUPPL -4	View Letter (PDF)
Feb 26, 2015	SUPPL -3	View Letter (PDF)
Apr 24, 2012	SUPPL -1	View Letter (PDF)
Oct 14, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

RLD

0 patents3 exclusivities▴

TABLET;ORAL | Approved: Oct 14, 2011

Exclusivities (3)

Code	Date	Status
ODE-417	Apr 30, 2028	Active
ODE-420	Apr 30, 2028	Active
ODE-421	Apr 30, 2028	Active

#002 — 1GM

RLDAB

0 patents3 exclusivities▾

TABLET;ORAL | Approved: Jul 25, 2019