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OmniRx › Tools › Generic competition check › Ensifentrine

Generic competition · all medicines · read 12 November 2026

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

Ensifentrine 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.
Ensifentrine1 dosage-form group in the Orange Book
0generic makers listed
  1. Ensifentrine 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, Inhalation

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2024data datePatent 9062047 listed to expire 21 August 2031Patent 9956171 listed to expire 15 September 2035Patent 10945950 listed to expire 15 September 2035Patent 12409180 listed to expire 20 February 2043Patent 12251384 listed to expire 25 June 2044Exclusivity NCE to 26 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 26 June 2029Exclusivity NCE Ohtuvayre
  • 21 August 2031Patent 9062047 drug substance
  • 15 September 2035Patent 9956171 drug product
  • 15 September 2035Patent 10945950 drug product
  • 20 February 2043Patent 12409180 drug product
  • 25 June 2044Patent 12251384 drug product

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.