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OmniRx › Tools › Generic competition check › Lumateperone Tosylate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Lumateperone Tosylate, and who makes it?

Lumateperone Tosylate 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.
Lumateperone Tosylate1 dosage-form group in the Orange Book
0generic makers listed
  1. Lumateperone Tosylate 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.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2019data datePatent 10464938 listed to expire 12 March 2028Patent 9199995 listed to expire 12 March 2029Patent RE48825 listed to expire 12 March 2029Patent 9586960 listed to expire 12 March 2029Patent 10117867 listed to expire 27 May 2029Patent 9168258 listed to expire 27 May 2029Patent 9616061 listed to expire 27 May 2029Patent 8648077 listed to expire 1 December 2029Patent RE48839 listed to expire 19 August 2033Patent 11026951 listed to expire 3 December 2034Patent 9956227 listed to expire 3 December 2034Patent 10960009 listed to expire 3 December 2034Patent 12409176 listed to expire 15 March 2039Patent 11806348 listed to expire 30 August 2039Patent 11690842 listed to expire 30 August 2039Patent 11052084 listed to expire 30 August 2039Patent 10695345 listed to expire 30 August 2039Patent 12128043 listed to expire 30 August 2039Patent 12070459 listed to expire 30 August 2039Patent 11980617 listed to expire 27 October 2039Patent 12090155 listed to expire 7 July 2040Patent 12122792 listed to expire 10 December 2040Patent 12410195 listed to expire 10 December 2040Exclusivity I-904 to 5 November 2028Exclusivity M-319 to 24 April 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 5 November 2028Exclusivity I-904 Caplyta
  • 24 April 2029Exclusivity M-319 Caplyta
  • 12 March 2028Patent 10464938 drug product
  • 12 March 2029Patent 9199995
  • 12 March 2029Patent RE48825 drug substance
  • 12 March 2029Patent 9586960 drug substance
  • 27 May 2029Patent 10117867
  • 27 May 2029Patent 9168258 drug product
  • 27 May 2029Patent 9616061 drug product
  • 1 December 2029Patent 8648077 drug substance

15 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.