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 Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
7
Listed patents
1
Next patent expiry
Dec 23, 2041
in 15 yr 5 mo
Brand (NDA) products
Originator applications
- NOVA LABS LTDNDA 2165932024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx — - THERAVIANDA 20884320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx — 1GM TABLET ORAL Rx — - DROXIARLDWAYLIS 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 —
Generic (ANDA) products (7)
Abbreviated applications
- HYDROXYUREAQILUANDA 2180212024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Rx AB - HYDROXYUREALEADINGANDA 2134382020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Rx AB - HYDROXYUREABARRANDA 07514320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Rx AB 250MG CAPSULE ORAL Discontinued — - HYDROXYUREABARRANDA 0757342000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued — - HYDROXYUREABARR LABS INCANDA 07502020002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — 250MG CAPSULE ORAL Discontinued — - HYDROXYUREAPH HEALTHANDA 0753401999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Rx AB - HYDROXYUREAROXANEANDA 0744761995
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)
in 6 mo
- ODE-470Orphan-drug exclusivity (7 years)
in 4 yr 7 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12409156 | in 15 yr 5 mo | Product |
Approval history
FDA approval span
First approval
31 yr 7 mo ago
Most recent approval
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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
