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Generic competition · all medicines · read 12 November 2026

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

Lumasiran 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.
Lumasiran Sodium1 dosage-form group in the Orange Book
0generic makers listed
  1. Lumasiran 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: Oxlumo. No generic is listed as marketed.

20202025203020352040204501brand 2020data datePatent 10131907 listed to expire 24 August 2028Patent 8828956 listed to expire 4 December 2028Patent 8106022 listed to expire 12 December 2029Patent 11060093 listed to expire 26 December 2034Patent 10465195 listed to expire 26 December 2034Patent 10435692 listed to expire 26 December 2034Patent 10487330 listed to expire 26 December 2034Patent 9828606 listed to expire 26 December 2034Patent 11401517 listed to expire 14 August 2035Patent 10612024 listed to expire 14 August 2035Patent 10612027 listed to expire 14 August 2035Patent 10478500 listed to expire 9 October 2035Patent 11446380 listed to expire 9 October 2035Patent 11261447 listed to expire 20 November 2038Patent 12723247 listed to expire 29 May 2041Exclusivity ODE-339 to 23 November 2027Exclusivity ODE-415 to 6 October 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 23 November 2027Exclusivity ODE-339 Oxlumo
  • 6 October 2029Exclusivity ODE-415 Oxlumo
  • 24 August 2028Patent 10131907 drug substance
  • 4 December 2028Patent 8828956 drug substance
  • 12 December 2029Patent 8106022 drug substance
  • 26 December 2034Patent 11060093 drug substance
  • 26 December 2034Patent 10465195 drug substance
  • 26 December 2034Patent 10435692
  • 26 December 2034Patent 10487330 drug substance
  • 26 December 2034Patent 9828606 drug substance

7 more patents are listed.

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.