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OmniRx › Tools › Generic competition check › Hydroxyurea

Generic competition · all medicines · read 12 November 2026

Is there a generic of Hydroxyurea, and who makes it?

Hydroxyurea appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Hydroxyurea3 dosage-form groups in the Orange Book
4generic makers listed
  1. Hydroxyurea appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them.
  2. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Capsule, Oral

Four or more generic makers listed

Brand listed as marketed: Droxia and Hydrea. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 18 August 1995.

1995200020052010201520202025203004brand 1998Barr Laboratories Inc, first approval 16 October 1998Ph Health Ltd, first approval 24 February 1999Leading Pharma Llc, first approval 8 April 2020Qilu Pharmaceutical Co Ltd, first approval 6 March 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Barr Laboratories Inc16 October 19981
Ph Health Ltd24 February 19991
Leading Pharma Llc8 April 20201
Qilu Pharmaceutical Co Ltd6 March 20241

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Siklos. No generic is listed as marketed (1 generic product listed as discontinued).

201520202025203001brand 2017data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Xromi. No generic is listed as marketed.

20202025203020352040204501brand 2024data datePatent 12409156 listed to expire 23 December 2041Exclusivity NP to 4 April 2027Exclusivity ODE-470 to 4 April 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 4 April 2027Exclusivity NP Xromi
  • 4 April 2031Exclusivity ODE-470 Xromi
  • 23 December 2041Patent 12409156 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.