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OmniRx › Tools › Generic competition check › Ganaxolone

Generic competition · all medicines · read 12 November 2026

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

Ganaxolone 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.
Ganaxolone1 dosage-form group in the Orange Book
0generic makers listed
  1. Ganaxolone 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.

Suspension, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2022data datePatent 8618087 listed to expire 28 November 2026Patent 9056116 listed to expire 28 November 2026Patent 7858609 listed to expire 28 November 2026Patent 8022054 listed to expire 28 November 2026Patent 8367651 listed to expire 28 November 2026Patent 9029355 listed to expire 28 November 2026Patent 8318714 listed to expire 28 November 2031Patent 12144801 listed to expire 10 August 2037Patent 10603308 listed to expire 10 August 2037Patent 12115169 listed to expire 30 September 2042Patent 12268696 listed to expire 30 September 2042Exclusivity NCE to 1 June 2027Exclusivity D-197 to 16 October 2028Exclusivity ODE-395 to 1 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 June 2027Exclusivity NCE Ztalmy
  • 16 October 2028Exclusivity D-197 Ztalmy
  • 1 June 2029Exclusivity ODE-395 Ztalmy
  • 28 November 2026Patent 8618087
  • 28 November 2026Patent 9056116
  • 28 November 2026Patent 7858609 drug product
  • 28 November 2026Patent 8022054 drug product
  • 28 November 2026Patent 8367651 drug product
  • 28 November 2026Patent 9029355 drug product
  • 28 November 2031Patent 8318714 drug product
  • 10 August 2037Patent 12144801

3 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.