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Budesonide/Formoterol SPIROMAX® — Competitive Intelligence Brief

Budesonide/Formoterol SPIROMAX® (Budesonide/Formoterol SPIROMAX®) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination. Area: Respiratory/Pulmonology.

phase 3 Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) Respiratory/Pulmonology Small molecule Live · refreshed every 30 min

Target snapshot

Budesonide/Formoterol SPIROMAX® (Budesonide/Formoterol SPIROMAX®) — Teva Branded Pharmaceutical Products R&D, Inc.. Budesonide/Formoterol combines an inhaled corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Budesonide/Formoterol SPIROMAX® TARGET Budesonide/Formoterol SPIROMAX® Teva Branded Pharmaceutical Products R&D, Inc. phase 3 Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
Beclometasone/Formoterol Beclometasone/Formoterol Chiesi Farmaceutici S.p.A. marketed Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (beclometasone); beta-2 adrenergic receptor (formoterol)
FF FF GlaxoSmithKline marketed Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor; beta-2 adrenergic receptor
mometasone furoate and formoterol mometasone furoate and formoterol Sanofi marketed Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (mometasone); beta-2 adrenergic receptor (formoterol)
CHF 1535 100/6 NEXT DPI® 2 months CHF 1535 100/6 NEXT DPI® 2 months Chiesi Farmaceutici S.p.A. phase 3 Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor; beta-2 adrenergic receptor
Fluticasone Furoate/GW642444 Fluticasone Furoate/GW642444 GlaxoSmithKline phase 3 Long-acting inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (fluticasone furoate); beta-2 adrenergic receptor (GW642444/vilanterol)
FlutiForm 250/10 FlutiForm 250/10 SkyePharma AG phase 3 Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (formoterol)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination class)

  1. Chiesi Farmaceutici S.p.A. · 6 drugs in this class
  2. Alfredo Antonio Chetta · 1 drug in this class
  3. GlaxoSmithKline · 1 drug in this class
  4. Sanofi · 1 drug in this class
  5. SkyePharma AG · 1 drug in this class
  6. Teva Branded Pharmaceutical Products R&D, Inc. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Budesonide/Formoterol SPIROMAX® — Competitive Intelligence Brief. https://druglandscape.com/ci/budesonide-formoterol-spiromax. Accessed 2026-05-16.

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