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OmniRx › Tools › Generic competition check › Inclisiran Sodium

Generic competition · all medicines · read 12 November 2026

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

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

2020202520302035204001brand 2021data datePatent 8809292 listed to expire 10 May 2027Patent 8222222 listed to expire 29 December 2027Patent 10131907 listed to expire 24 August 2028Patent 9370582 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 10125369 listed to expire 18 August 2034Patent 12460206 listed to expire 18 August 2034Patent 10851377 listed to expire 25 August 2036Exclusivity NCE to 22 December 2026Exclusivity I-985 to 12 February 2029Exclusivity NPP to 12 February 2029Exclusivity ODE-555 to 12 February 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 December 2026Exclusivity NCE Leqvio
  • 12 February 2029Exclusivity I-985 Leqvio
  • 12 February 2029Exclusivity NPP Leqvio
  • 12 February 2033Exclusivity ODE-555 Leqvio
  • 10 May 2027Patent 8809292 drug substance
  • 29 December 2027Patent 8222222
  • 24 August 2028Patent 10131907 drug substance
  • 4 December 2028Patent 9370582 drug substance
  • 4 December 2028Patent 8828956 drug substance
  • 4 December 2028Patent 10806791 drug substance
  • 12 December 2029Patent 8106022 drug substance
  • 18 August 2034Patent 10125369 drug substance

2 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.