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Generic competition · all medicines · read 12 November 2026

Is there a generic of Cariprazine Hydrochloride, and who makes it?

Cariprazine Hydrochloride 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. Where both are dated, the first generic approval came 7 years after the first brand approval. 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.
Cariprazine Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Cariprazine Hydrochloride 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. Where both are dated, the first generic approval came 7 years after the first brand approval.
  4. 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: Vraylar. No generic is listed as marketed (11 generic products listed as discontinued).

201520202025203001brand 2015data datePatent 7943621 listed to expire 20 December 2028Patent 7943621*PED listed to expire 20 June 2029Patent RE49110 listed to expire 16 July 2029Patent RE47350 listed to expire 16 July 2029Patent RE49302 listed to expire 16 July 2029Patent 7737142 listed to expire 17 September 2029Patent RE49110*PED listed to expire 16 January 2030Patent RE47350*PED listed to expire 16 January 2030Patent RE49302*PED listed to expire 16 January 2030Patent 7737142*PED listed to expire 17 March 2030Exclusivity M-14 to 18 December 2028Exclusivity NPP to 18 December 2028Exclusivity PED to 18 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 18 December 2028Exclusivity M-14 Vraylar
  • 18 December 2028Exclusivity NPP Vraylar
  • 18 June 2029Exclusivity PED Vraylar
  • 20 December 2028Patent 7943621 drug substance
  • 20 June 2029Patent 7943621*PED
  • 16 July 2029Patent RE49110
  • 16 July 2029Patent RE47350
  • 16 July 2029Patent RE49302
  • 17 September 2029Patent 7737142 drug substance
  • 16 January 2030Patent RE49110*PED
  • 16 January 2030Patent RE47350*PED

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.