Aclidinium Bromide 400 µg — Competitive Intelligence Brief

Aclidinium Bromide 400 µg (Aclidinium Bromide 400 µg) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting muscarinic antagonist (LAMA). Area: Respiratory.

phase 3 Long-acting muscarinic antagonist (LAMA) Muscarinic M3 receptor Respiratory Small molecule

Target snapshot

Aclidinium Bromide 400 µg (Aclidinium Bromide 400 µg) — AstraZeneca. Aclidinium bromide is a muscarinic M3 receptor antagonist that blocks acetylcholine signaling in airway smooth muscle, causing bronchodilation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Aclidinium Bromide 400 µg TARGET	Aclidinium Bromide 400 µg	AstraZeneca	phase 3	Long-acting muscarinic antagonist (LAMA)	Muscarinic M3 receptor
umeclidinium 62.5 µg and vilanterol 25 µg	umeclidinium 62.5 µg and vilanterol 25 µg	University of Tennessee Graduate School of Medicine	marketed	Long-acting anticholinergic and long-acting beta-2 agonist combination (LAMA/LABA)	Muscarinic M3 receptor (umeclidinium); Beta-2 adrenergic receptor (vilanterol)
Aclidinium bromide/formoterol fumarate combination	Aclidinium bromide/formoterol fumarate combination	AstraZeneca	marketed	Long-acting anticholinergic/long-acting beta-2 agonist combination (LAMA/LABA)	Muscarinic M3 receptor and beta-2 adrenergic receptor
Tiotropium & olodaterol	Tiotropium & olodaterol	University of Dundee	marketed	Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA)	Muscarinic M3 receptor; beta-2 adrenergic receptor
Trimbow pMDI	Trimbow pMDI	Medicines Evaluation Unit Ltd	marketed	Triple combination inhaler (ICS/LABA/LAMA)	Glucocorticoid receptor, beta-2 adrenergic receptor, muscarinic M3 receptor
tolterodine , mirabegron	tolterodine , mirabegron	Far Eastern Memorial Hospital	marketed	Antimuscarinic and beta-3 adrenergic agonist combination	Muscarinic M3 receptor and beta-3 adrenergic receptor
UMEC/VI DPI	UMEC/VI DPI	GlaxoSmithKline	marketed	Long-acting muscarinic antagonist / long-acting beta-2 agonist combination (LAMA/LABA)	Muscarinic M3 receptor (umeclidinium); Beta-2 adrenergic receptor (vilanterol)

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 (LAMA) class)

1. GlaxoSmithKline · 9 drugs in this class
2. AstraZeneca · 3 drugs in this class
3. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 1 drug in this class
4. Chiesi Farmaceutici S.p.A. · 1 drug in this class
5. IRCCS Azienda Ospedaliero-Universitaria di Bologna · 1 drug in this class
6. Lupin, Inc. · 1 drug in this class
7. Sanofi · 1 drug in this class