Aclidinium bromide & formoterol fumarate — Competitive Intelligence Brief

Aclidinium bromide & formoterol fumarate (Aclidinium bromide & formoterol fumarate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA). Area: Respiratory / Pulmonology.

marketed Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA) M3 muscarinic receptor; beta-2 adrenergic receptor Respiratory / Pulmonology Small molecule

Target snapshot

Aclidinium bromide & formoterol fumarate (Aclidinium bromide & formoterol fumarate) — University of Dundee. Aclidinium bromide and formoterol fumarate is a combination bronchodilator that blocks muscarinic receptors (anticholinergic) and activates beta-2 adrenergic receptors to relax airway smooth muscle and improve airflow.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Aclidinium bromide & formoterol fumarate TARGET	Aclidinium bromide & formoterol fumarate	University of Dundee	marketed	Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA)	M3 muscarinic receptor; beta-2 adrenergic receptor
Glycopyrrolate + Formoterol	Glycopyrrolate + Formoterol	Chiesi Farmaceutici S.p.A.	marketed	Long-acting muscarinic antagonist (LAMA) + long-acting beta-2 agonist (LABA) combination	M3 muscarinic receptor; beta-2 adrenergic receptor
Revefenacin 175 µg, Formoterol 20 µg	Revefenacin 175 µg, Formoterol 20 µg	University of Tennessee Graduate School of Medicine	marketed	Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA)	M3 muscarinic receptor; beta-2 adrenergic receptor
Umeclidinium/Vilanterol 62.5/25 mcgs	Umeclidinium/Vilanterol 62.5/25 mcgs	National Institute of Respiratory Diseases, Mexico	marketed	Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA)	M3 muscarinic receptor; beta-2 adrenergic receptor
Umeclidinium / Vilanterol Dry Powder Inhaler	Umeclidinium / Vilanterol Dry Powder Inhaler	Gary L. Pierce	marketed	Long-acting muscarinic antagonist / Long-acting beta-2 agonist combination (LAMA/LABA)	M3 muscarinic receptor; beta-2 adrenergic receptor
GSK573719/GW642444 Inhalation Powder	GSK573719/GW642444 Inhalation Powder	GlaxoSmithKline	phase 3	LAMA/LABA combination (long-acting muscarinic antagonist/long-acting beta-2 agonist)	M3 muscarinic receptor; beta-2 adrenergic receptor
GSK573719 + GW642444 62.5/25	GSK573719 + GW642444 62.5/25	GlaxoSmithKline	phase 3	Long-acting muscarinic antagonist / long-acting beta-2 agonist (LAMA/LABA combination)	M3 muscarinic receptor; beta-2 adrenergic 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 (Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA) class)

1. GlaxoSmithKline · 5 drugs in this class
2. University of Dundee · 2 drugs in this class
3. National Institute of Respiratory Diseases, Mexico · 1 drug in this class
4. University of Tennessee Graduate School of Medicine · 1 drug in this class