Is there a generic for Deferiprone?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Deferiprone, referencing the brand FERRIPROX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Deferiprone?

FERRIPROX (NDA 212269, CHIESI) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Deferiprone?

The Orange Book lists 7 patents against Deferiprone products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Deferiprone have FDA marketing exclusivity?

Yes. The Orange Book records 15 marketing-exclusivity periods for Deferiprone. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Deferiprone are approved?

Deferiprone is approved in the following dosage forms: solution, tablet.

FDA Orange Book · active-ingredient family

Deferiprone

Deferiprone: 3 brands, 3 generics; first approved Oct 14, 2011; generic available.

Generic available15 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 3 ANDA applications approved.

Earliest patent expiry Oct 26, 2029Latest exclusivity ends Apr 30, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 26, 2029

in 3 yr 3 mo

Brand (NDA) products

Originator applications

FERRIPROXRLDRS
CHIESINDA 2122692020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM TABLET ORAL Rx —
FERRIPROXRLD
CHIESINDA 02182520192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Discontinued —
1GM TABLET ORAL Rx AB
FERRIPROXRLD
CHIESINDA 20803020182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML SOLUTION ORAL Rx —
80MG/ML SOLUTION ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Discontinued	—
1GM	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	SOLUTION	ORAL	Rx	—
80MG/ML	SOLUTION	ORAL	Discontinued	—

Generic (ANDA) products (3)

Abbreviated applications

DEFERIPRONE
SENORES PHARMSANDA 22013220252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx AB
1GM TABLET ORAL Rx AB
DEFERIPRONE
TAROANDA 20880020232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx AB
1GM TABLET ORAL Rx AB
DEFERIPRONERS
HIKMAANDA 21323920222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET ORAL Rx AB
1GM TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB
1GM	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB
1GM	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	ORAL	Rx	AB
1GM	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-418Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-419Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-418Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-419Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo
ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 9 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8703156	Oct 26, 2029	in 3 yr 3 mo	ProductU-3083
11723874	Oct 25, 2038	in 12 yr 4 mo	U-3083
11357731	Oct 25, 2038	in 12 yr 4 mo	U-3083
10940115	Oct 25, 2038	in 12 yr 4 mo	ProductU-3083
10780055	Oct 25, 2038	in 12 yr 4 mo	ProductU-3083
11458103	Oct 25, 2038	in 12 yr 4 mo	Product
10940116	Oct 25, 2038	in 12 yr 4 mo	Product

Approval history

FDA approval span

First approval

Oct 14, 2011

15 yr 1 mo ago

Most recent approval

Dec 11, 2025

9 mo ago

Approvals span 2011–2025 across 6 FDA applications.

Brand (NDA) 350%

Generic (ANDA) 350%

Deferiprone: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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