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OmniRx › Tools › Generic competition check › Budesonide

Generic competition · all medicines · read 12 November 2026

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

Budesonide appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them. 2 groups have 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 between 0.7 and 9.6 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.
Budesonide8 dosage-form groups in the Orange Book
16generic makers listed
  1. Budesonide appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them.
  2. 2 groups have 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 between 0.7 and 9.6 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.

Suspension, Inhalation

Four or more generic makers listed

Brand listed as marketed: Pulmicort Respules. 7 generic makers with 15 generic products listed as marketed; the first generic approval is dated 18 November 2008.

200020052010201520202025203007brand 2000Teva Pharmaceuticals Usa, first approval 18 November 2008Nephron Pharmaceuticals Corporation, first approval 30 March 2009Impax Laboratories Inc, first approval 31 July 2012Cipla Ltd, first approval 16 November 2017Lupin Inc, first approval 9 November 2018Sun Pharmaceutical Industries Ltd, first approval 14 April 2021Eugia Pharma Specialities Ltd, first approval 29 November 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Teva Pharmaceuticals Usa18 November 20083
Nephron Pharmaceuticals Corporation30 March 20092
Impax Laboratories Inc31 July 20122
Cipla Ltd16 November 20173
Lupin Inc9 November 20181
Sun Pharmaceutical Industries Ltd14 April 20213
Eugia Pharma Specialities Ltd29 November 20231

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Capsule, Delayed Release, Oral

Four or more generic makers listed

Brand listed as marketed: Entocort Ec and Tarpeyo. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 16 May 2011.

200020052010201520202025203020352040204505brand 2001Aurobindo Pharma Usa Inc, first approval 16 May 2011Dr Reddys Laboratories Sa, first approval 8 April 2016Rising Pharma Holdings Inc, first approval 7 April 2017Zydus Pharmaceuticals Usa Inc, first approval 4 May 2017Amneal Pharmaceuticals Of New York Llc, first approval 31 July 2017data datePatent 8491932 listed to expire 7 May 2029Patent 11896719 listed to expire 23 January 2043Patent 12171882 listed to expire 23 January 2043Patent 12311057 listed to expire 23 January 2043Patent 12171883 listed to expire 23 January 2043Exclusivity ODE-389 to 15 December 2028Exclusivity ODE-464 to 20 December 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Aurobindo Pharma Usa Inc16 May 20111
Dr Reddys Laboratories Sa8 April 20161
Rising Pharma Holdings Inc7 April 20171
Zydus Pharmaceuticals Usa Inc4 May 20171
Amneal Pharmaceuticals Of New York Llc31 July 20171

Patents and exclusivities still listed

  • 15 December 2028Exclusivity ODE-389 Tarpeyo
  • 20 December 2030Exclusivity ODE-464 Tarpeyo
  • 7 May 2029Patent 8491932 drug product
  • 23 January 2043Patent 11896719
  • 23 January 2043Patent 12171882
  • 23 January 2043Patent 12311057 drug product
  • 23 January 2043Patent 12171883 drug product

Powder, Metered, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Pulmicort Flexhaler. No generic is listed as marketed.

1995200020052010201520202025203001brand 1997data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Extended Release, Oral

One to three generic makers listed

Brand listed as marketed: Uceris. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 3 July 2018.

20102015202020252030203502brand 2013Actavis Laboratories Fl Inc, first approval 3 July 2018Mylan Pharmaceuticals Inc, first approval 17 September 2020data datePatent 9192581 listed to expire 7 September 2031Patent 8895064 listed to expire 7 September 2031Patent 10660858 listed to expire 7 September 2031Patent 10307375 listed to expire 7 September 2031Patent 9132093 listed to expire 7 September 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Laboratories Fl Inc3 July 20181
Mylan Pharmaceuticals Inc17 September 20201

Patents and exclusivities still listed

  • 7 September 2031Patent 9192581 drug product
  • 7 September 2031Patent 8895064 drug product
  • 7 September 2031Patent 10660858 drug product
  • 7 September 2031Patent 10307375 drug product
  • 7 September 2031Patent 9132093 drug product

Aerosol, Foam, Rectal

One to three generic makers listed

Brand listed as marketed: Uceris. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 12 April 2023.

2010201520202025203001brand 2014Padagis Israel Pharmaceuticals Ltd, first approval 12 April 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Padagis Israel Pharmaceuticals Ltd12 April 20231

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Spray, Metered, Nasal

One to three generic makers listed

Brand listed as marketed: Rhinocort Allergy. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 20 November 2015.

201520202025203001brand 2015Apotex Inc, first approval 20 November 2015data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Apotex Inc20 November 20151

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Aerosol, Metered, Nasal

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

19901995200020052010201520202025203001brand 1994data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Suspension, Oral

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2024data datePatent 11357859 listed to expire 12 November 2028Patent 10293052 listed to expire 22 November 2028Patent 9050368 listed to expire 1 August 2029Patent 8324192 listed to expire 3 August 2029Patent 11564934 listed to expire 10 January 2039Patent 11260064 listed to expire 10 January 2039Exclusivity NP to 9 February 2027Exclusivity ODE-466 to 9 February 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 9 February 2027Exclusivity NP Eohilia
  • 9 February 2031Exclusivity ODE-466 Eohilia
  • 12 November 2028Patent 11357859
  • 22 November 2028Patent 10293052 drug product
  • 1 August 2029Patent 9050368 drug product
  • 3 August 2029Patent 8324192
  • 10 January 2039Patent 11564934
  • 10 January 2039Patent 11260064 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.