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Budesonide/Glycopyrronium/Formoterol Fumarate — Competitive Intelligence Brief

Budesonide/Glycopyrronium/Formoterol Fumarate (Budesonide/Glycopyrronium/Formoterol Fumarate) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA). Area: Respiratory/Pu

marketed Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol); muscarinic M3 receptor (glycopyrronium) Respiratory/Pulmonology Small molecule Live · refreshed every 30 min

Target snapshot

Budesonide/Glycopyrronium/Formoterol Fumarate (Budesonide/Glycopyrronium/Formoterol Fumarate) — AstraZeneca. This triple-combination inhaler delivers a corticosteroid (budesonide) to reduce airway inflammation, a long-acting beta-2 agonist (formoterol) to dilate airways, and an anticholinergic (glycopyrronium) to further relax airway smooth muscle.

Comparator set (5 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Budesonide/Glycopyrronium/Formoterol Fumarate TARGET Budesonide/Glycopyrronium/Formoterol Fumarate AstraZeneca marketed Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol); muscarinic M3 receptor (glycopyrronium)
FlF/VI + Tiotropium FlF/VI + Tiotropium Chiesi Farmaceutici S.p.A. phase 3 Triple combination therapy: inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor (fluticasone furoate), beta-2 adrenergic receptor (vilanterol), muscarinic M3 receptor (tiotropium)
CHF 5993 200/6/12.5 µg CHF 5993 200/6/12.5 µg Chiesi Farmaceutici S.p.A. phase 3 Triple combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor
Beclometasone/Formoterol/Glycopyrrolate Beclometasone/Formoterol/Glycopyrrolate Chiesi Farmaceutici S.p.A. phase 3 Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor (beclometasone); beta-2 adrenergic receptor (formoterol); muscarinic M3 receptor (glycopyrrolate)
BDP/FF/GB BDP/FF/GB Chiesi Farmaceutici S.p.A. phase 3 Triple-combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor
Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium Chiesi Farmaceutici S.p.A. phase 3 Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor

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/long-acting muscarinic antagonist (ICS/LABA/LAMA) class)

  1. Chiesi Farmaceutici S.p.A. · 2 drugs in this class
  2. AstraZeneca · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Budesonide/Glycopyrronium/Formoterol Fumarate — Competitive Intelligence Brief. https://druglandscape.com/ci/budesonide-glycopyrronium-formoterol-fumarate. Accessed 2026-05-18.

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