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OmniRx › Tools › Generic competition check › Olanzapine; Samidorphan L-Malate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Olanzapine; Samidorphan L-Malate, and who makes it?

Olanzapine; Samidorphan L-Malate 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.
Olanzapine; Samidorphan L-Malate1 dosage-form group in the Orange Book
0generic makers listed
  1. Olanzapine; Samidorphan L-Malate 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: Lybalvi. No generic is listed as marketed.

20202025203020352040204501brand 2021data datePatent 11241425 listed to expire 23 August 2031Patent 12194035 listed to expire 23 August 2031Patent 11185541 listed to expire 23 August 2031Patent 11793805 listed to expire 23 August 2031Patent 11351166 listed to expire 23 August 2031Patent 9126977 listed to expire 23 August 2031Patent 9517235 listed to expire 23 August 2031Patent 10716785 listed to expire 23 August 2031Patent 9119848 listed to expire 30 August 2031Patent 8778960 listed to expire 13 February 2032Patent 10300054 listed to expire 31 May 2033Patent 11951111 listed to expire 12 November 2041Patent 11707466 listed to expire 12 November 2041Patent 12390474 listed to expire 12 November 2041
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 23 August 2031Patent 11241425
  • 23 August 2031Patent 12194035
  • 23 August 2031Patent 11185541
  • 23 August 2031Patent 11793805
  • 23 August 2031Patent 11351166
  • 23 August 2031Patent 9126977 drug product
  • 23 August 2031Patent 9517235
  • 23 August 2031Patent 10716785

6 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.