Is there a generic for Hydroxyurea?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Hydroxyurea, referencing the brand XROMI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydroxyurea?

XROMI (NDA 216593, NOVA LABS LTD) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Hydroxyurea?

The Orange Book lists 1 patent against Hydroxyurea products, with the earliest listed expiry in 2041. 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 Hydroxyurea have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Hydroxyurea. 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 Hydroxyurea are approved?

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

FDA Orange Book · active-ingredient family

Hydroxyurea

Hydroxyurea: 3 brands, 7 generics; first approved Aug 18, 1995; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 7 ANDA applications approved.

Earliest patent expiry Dec 23, 2041Latest exclusivity ends Apr 04, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 23, 2041

in 15 yr 5 mo

Brand (NDA) products

Originator applications

XROMIRLDRS
NOVA LABS LTDNDA 2165932024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML SOLUTION ORAL Rx -
SIKLOSRLDRS
THERAVIANDA 20884320172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Rx -
1GM TABLET ORAL Rx -
DROXIARLD
WAYLIS THERAPNDA 01629519984 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
200MG CAPSULE ORAL Rx -
300MG CAPSULE ORAL Rx -
400MG CAPSULE ORAL Rx -

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	-
1GM	TABLET	ORAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
200MG	CAPSULE	ORAL	Rx	-
300MG	CAPSULE	ORAL	Rx	-
400MG	CAPSULE	ORAL	Rx	-

Generic (ANDA) products (7)

Abbreviated applications

HYDROXYUREA
QILUANDA 2180212024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
HYDROXYUREA
LEADINGANDA 2134382020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
HYDROXYUREA
BARRANDA 07514320002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
250MG CAPSULE ORAL Discontinued -
HYDROXYUREA
BARRANDA 0757342000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM TABLET ORAL Discontinued -
HYDROXYUREA
BARR LABS INCANDA 07502020002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Discontinued -
250MG CAPSULE ORAL Discontinued -
HYDROXYUREA
PH HEALTHANDA 0753401999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Rx AB
HYDROXYUREA
ROXANEANDA 0744761995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG CAPSULE ORAL Discontinued -

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Rx	AB
250MG	CAPSULE	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Discontinued	-
250MG	CAPSULE	ORAL	Discontinued	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	CAPSULE	ORAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Apr 04, 2027
in 5 mo
ODE-470Orphan-drug exclusivity (7 years)
Apr 04, 2031
in 4 yr 6 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
12409156	Dec 23, 2041	in 15 yr 5 mo	Product

Approval history

FDA approval span

First approval

Aug 18, 1995

31 yr 8 mo ago

Most recent approval

Apr 04, 2024

2 yr 7 mo ago

Approvals span 1995–2024 across 10 FDA applications.

Brand (NDA) 330%

Generic (ANDA) 770%

Hydroxyurea: 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.

Ask AI about Hydroxyurea

Key facts