Viewing data from:

FERRIPROX

NDA

DEFERIPRONE | N208030 | CHIESI USA INC

2 strengths1 unique patent3 unique exclusivities

Patent Timeline

1 unique patent, 3 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

Today

8703156

Oct. 26, 2029

ODE-417

Apr. 30, 2028

ODE-418

Apr. 30, 2028

ODE-419

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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

6 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	SUPPL -9	View Letter (PDF)
Dec 1, 2021	SUPPL -7	View Letter (PDF)
May 4, 2021	SUPPL -5	View Letter (PDF)
Feb 21, 2020	SUPPL -4	View Letter (PDF)
Apr 23, 2018	SUPPL -2	View Letter (PDF)
Sep 10, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/ML

RLD

1 patent3 exclusivities▴

SOLUTION;ORAL | Approved: Sep 9, 2015

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8703156	Oct 26, 2029	—	—	Yes		—

Exclusivities (3)

Code	Date	Status
ODE-417	Apr 30, 2028	Active
ODE-418	Apr 30, 2028	Active
ODE-419	Apr 30, 2028	Active

#002 — 80MG/ML

RLD

1 patent3 exclusivities▾

SOLUTION;ORAL | Approved: Apr 20, 2018