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OmniRx › Tools › Generic competition check › Nirogacestat Hydrobromide

Generic competition · all medicines · read 12 November 2026

Is there a generic of Nirogacestat Hydrobromide, and who makes it?

Nirogacestat Hydrobromide 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.
Nirogacestat Hydrobromide1 dosage-form group in the Orange Book
0generic makers listed
  1. Nirogacestat Hydrobromide 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: Ogsiveo. No generic is listed as marketed.

20202025203020352040204501brand 2023data datePatent 7795447 listed to expire 18 August 2030Patent 11845732 listed to expire 9 August 2039Patent 10941118 listed to expire 9 August 2039Patent 10710966 listed to expire 9 August 2039Patent 11884635 listed to expire 9 August 2039Patent 11820748 listed to expire 9 August 2039Patent 11905255 listed to expire 9 August 2039Patent 11884634 listed to expire 9 August 2039Patent 12297177 listed to expire 9 August 2039Patent 12116347 listed to expire 9 August 2039Patent 10590087 listed to expire 9 August 2039Patent 11612588 listed to expire 8 July 2042Patent 11504354 listed to expire 8 July 2042Patent 12247012 listed to expire 8 July 2042Patent 12234210 listed to expire 8 July 2042Patent 12599587 listed to expire 8 July 2042Patent 12110277 listed to expire 8 July 2042Patent 11844780 listed to expire 8 September 2042Patent 11807611 listed to expire 8 September 2042Patent 12138246 listed to expire 19 May 2043Patent 12011435 listed to expire 19 May 2043Patent 12011434 listed to expire 19 May 2043Patent 11957662 listed to expire 19 May 2043Patent 11951096 listed to expire 19 May 2043Patent 11938116 listed to expire 19 May 2043Patent 11925620 listed to expire 19 May 2043Patent 11925619 listed to expire 19 May 2043Patent 12036207 listed to expire 19 May 2043Patent 11872211 listed to expire 19 May 2043Exclusivity NCE to 27 November 2028Exclusivity ODE* to 27 November 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 27 November 2028Exclusivity NCE Ogsiveo
  • 27 November 2030Exclusivity ODE* Ogsiveo
  • 18 August 2030Patent 7795447 drug substance
  • 9 August 2039Patent 11845732 drug substance
  • 9 August 2039Patent 10941118 drug substance
  • 9 August 2039Patent 10710966 drug substance
  • 9 August 2039Patent 11884635 drug product
  • 9 August 2039Patent 11820748 drug product
  • 9 August 2039Patent 11905255 drug product
  • 9 August 2039Patent 11884634 drug product

21 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.