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OmniRx › Tools › Generic competition check › Sotorasib

Generic competition · all medicines · read 12 November 2026

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

Sotorasib 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.
Sotorasib1 dosage-form group in the Orange Book
0generic makers listed
  1. Sotorasib 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.

Tablet, Oral

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2021data datePatent 10519146 listed to expire 21 May 2038Patent 12280056 listed to expire 18 November 2039Patent 12398133 listed to expire 20 May 2040Patent 11236091 listed to expire 20 May 2040Patent 11827635 listed to expire 20 May 2040Patent 11426404 listed to expire 15 September 2040Exclusivity I-962 to 16 January 2028Exclusivity ODE-352 to 28 May 2028Exclusivity ODE* to 28 May 2028Exclusivity ODE-507 to 16 January 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 January 2028Exclusivity I-962 Lumakras
  • 28 May 2028Exclusivity ODE-352 Lumakras
  • 28 May 2028Exclusivity ODE* Lumakras
  • 16 January 2032Exclusivity ODE-507 Lumakras
  • 21 May 2038Patent 10519146 drug substance
  • 18 November 2039Patent 12280056
  • 20 May 2040Patent 12398133 drug substance
  • 20 May 2040Patent 11236091 drug substance
  • 20 May 2040Patent 11827635 drug substance
  • 15 September 2040Patent 11426404

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.