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Generic competition · all medicines · read 12 November 2026

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

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

2020202520302035204001brand 2022data datePatent 10131907 listed to expire 24 August 2028Patent 9370581 listed to expire 4 December 2028Patent 8828956 listed to expire 4 December 2028Patent 10806791 listed to expire 4 December 2028Patent 8106022 listed to expire 12 December 2029Patent 9399775 listed to expire 16 November 2032Patent 10570391 listed to expire 16 November 2032Patent 11401517 listed to expire 14 August 2035Patent 10612024 listed to expire 14 August 2035Patent 11286486 listed to expire 28 July 2036Patent 10683501 listed to expire 28 July 2036Patent 10208307 listed to expire 28 July 2036Patent 12049628 listed to expire 28 July 2036Exclusivity NCE to 13 June 2027Exclusivity I-964 to 20 March 2028Exclusivity ODE-212 to 13 June 2029Exclusivity ODE-527 to 20 March 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 13 June 2027Exclusivity NCE Amvuttra
  • 20 March 2028Exclusivity I-964 Amvuttra
  • 13 June 2029Exclusivity ODE-212 Amvuttra
  • 20 March 2032Exclusivity ODE-527 Amvuttra
  • 24 August 2028Patent 10131907 drug substance
  • 4 December 2028Patent 9370581 drug substance
  • 4 December 2028Patent 8828956 drug substance
  • 4 December 2028Patent 10806791 drug substance
  • 12 December 2029Patent 8106022 drug substance
  • 16 November 2032Patent 9399775 drug substance
  • 16 November 2032Patent 10570391 drug substance
  • 14 August 2035Patent 11401517 drug substance

5 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.