Viewing data from:

FERRIPROX

NDA

DEFERIPRONE | N212269 | CHIESI USA INC

1 strength6 unique patents3 unique exclusivities

Patent Timeline

6 unique patents, 3 exclusivities by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

Oct. 25, 2038

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

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

4 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	SUPPL -6	View Letter (PDF)
Dec 1, 2021	SUPPL -3	View Letter (PDF)
May 4, 2021	SUPPL -1	View Letter (PDF)
May 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM

RLD

6 patents3 exclusivities▴

TABLET;ORAL | Approved: May 19, 2020

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10780055	Oct 25, 2038	—	—	Yes		—
10940115	Oct 25, 2038	—	—	Yes		—
10940116	Oct 25, 2038	—	—	Yes	—	—
11357731	Oct 25, 2038	—	—	—		—
11458103	Oct 25, 2038	—	—	Yes	—	—
11723874	Oct 25, 2038	—	—	—		—

Exclusivities (3)

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