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Generic competition · all medicines · read 12 November 2026

Is there a generic of Fitusiran Sodium, and who makes it?

Fitusiran Sodium appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has 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.
Fitusiran Sodium1 dosage-form group in the Orange Book
0generic makers listed
  1. Fitusiran Sodium appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 1 group has 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.

Solution, Subcutaneous

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2025data datePatent 9376680 listed to expire 15 March 2033Patent 9127274 listed to expire 22 March 2033Patent RE50996 listed to expire 22 March 2033Patent 11091759 listed to expire 7 December 2036Exclusivity NCE to 28 March 2030Exclusivity ODE-510 to 28 March 2032Exclusivity ODE-511 to 28 March 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 28 March 2030Exclusivity NCE Qfitlia
  • 28 March 2032Exclusivity ODE-510 Qfitlia
  • 28 March 2032Exclusivity ODE-511 Qfitlia
  • 15 March 2033Patent 9376680 drug substance
  • 22 March 2033Patent 9127274 drug substance
  • 22 March 2033Patent RE50996 drug substance
  • 7 December 2036Patent 11091759

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.