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OmniRx › Tools › Generic competition check › Nitisinone

Generic competition · all medicines · read 12 November 2026

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

Nitisinone appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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. Where both are dated, the first generic approval came 17.6 years after the first brand approval. 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.
Nitisinone3 dosage-form groups in the Orange Book
3generic makers listed
  1. Nitisinone appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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. Where both are dated, the first generic approval came 17.6 years after the first brand approval.
  4. 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

One to three generic makers listed

Brand listed as marketed: Orfadin. 3 generic makers with 11 generic products listed as marketed; the first generic approval is dated 26 August 2019.

200020052010201520202025203003brand 2002Novitium Pharma Llc, first approval 26 August 2019Medunik Canada Inc, first approval 26 May 2022Eton Pharmaceuticals Inc, first approval 25 May 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Novitium Pharma Llc26 August 20193
Medunik Canada Inc26 May 20224
Eton Pharmaceuticals Inc25 May 20234

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: Harliku and Nityr. No generic is listed as marketed.

2015202020252030203501brand 2017data datePatent 10328029 listed to expire 5 January 2035Exclusivity ODE-529 to 10 June 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 10 June 2032Exclusivity ODE-529 Harliku
  • 5 January 2035Patent 10328029 drug product

Suspension, Oral

Brand listed, no generic listed as marketed

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

2015202020252030203501brand 2016data datePatent 9301932 listed to expire 28 February 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 28 February 2033Patent 9301932 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.