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OmniRx › Tools › Generic competition check › Budesonide; Formoterol Fumarate; Glycopyrrolate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Budesonide; Formoterol Fumarate; Glycopyrrolate, and who makes it?

Budesonide; Formoterol Fumarate; Glycopyrrolate 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.
Budesonide; Formoterol Fumarate; Glycopyrrolate1 dosage-form group in the Orange Book
0generic makers listed
  1. Budesonide; Formoterol Fumarate; Glycopyrrolate 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.

Aerosol, Metered, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Breztri Aerosphere. No generic is listed as marketed.

2020202520302035204001brand 2020data datePatent 8703806 listed to expire 28 May 2030Patent 8808713 listed to expire 28 May 2030Patent 8324266 listed to expire 28 May 2030Patent 9415009 listed to expire 28 May 2030Patent 10716753 listed to expire 28 May 2030Patent 9463161 listed to expire 28 May 2030Patent 8815258 listed to expire 17 March 2031Patent 11833292 listed to expire 5 October 2038Patent 11331442 listed to expire 5 October 2038Exclusivity NS to 27 April 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 27 April 2029Exclusivity NS Breztri Aerosphere
  • 28 May 2030Patent 8703806
  • 28 May 2030Patent 8808713 drug product
  • 28 May 2030Patent 8324266
  • 28 May 2030Patent 9415009
  • 28 May 2030Patent 10716753 drug product
  • 28 May 2030Patent 9463161 drug product
  • 17 March 2031Patent 8815258
  • 5 October 2038Patent 11833292 drug product

1 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.