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FDA Orange Book · active-ingredient family

Hydroxyurea

Hydroxyurea is approved as 3 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XROMI · NDA 216593

3

Brand (NDA)

7

Generics (ANDA)

1

Listed patents

2

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
XROMIRLDNOVA LABS LTDNDA 216593—Apr 04, 2024
SIKLOSRLD×2THERAVIANDA 208843—Dec 21, 2017
DROXIARLD×4WAYLIS THERAPNDA 016295—Feb 25, 1998

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
HYDROXYUREAQILUANDA 218021ABMar 06, 2024
HYDROXYUREALEADINGANDA 213438ABApr 08, 2020
HYDROXYUREA×2BARRANDA 075143—Sep 21, 2000
HYDROXYUREABARRANDA 075734—Aug 29, 2000
HYDROXYUREA×2BARR LABS INCANDA 075020—Jun 26, 2000
HYDROXYUREAPH HEALTHANDA 075340ABFeb 24, 1999
HYDROXYUREAROXANEANDA 074476—Aug 18, 1995

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Apr 04, 2027

    in 10 mo

  • ODE-470Orphan-drug exclusivity (7 years)

    Apr 04, 2031

    in 4 yr 10 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12409156Dec 23, 2041in 15 yr 9 mo
Product

Hydroxyurea — frequently asked questions

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

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