tiotropium bromide inhalation powder HandiHaler — Competitive Intelligence Brief

tiotropium bromide inhalation powder HandiHaler (tiotropium bromide inhalation powder HandiHaler) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting muscarinic antagonist (LAMA). Area: Respiratory.

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

Target snapshot

tiotropium bromide inhalation powder HandiHaler (tiotropium bromide inhalation powder HandiHaler) — GlaxoSmithKline. Tiotropium is a long-acting anticholinergic (antimuscarinic) agent that blocks muscarinic M3 receptors on airway smooth muscle to produce sustained bronchodilation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
tiotropium bromide inhalation powder HandiHaler TARGET	tiotropium bromide inhalation powder HandiHaler	GlaxoSmithKline	marketed	Long-acting muscarinic antagonist (LAMA)	Muscarinic M3 receptor
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
umeclidinium bromide (UMEC)	umeclidinium bromide (UMEC)	GlaxoSmithKline	marketed	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)
Budesonide/Glycopyrronium/Formoterol Fumarate	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)
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)
FF/UMEC/VI	FF/UMEC/VI	Dr. Grace Parraga	marketed	Triple combination inhaler (ICS/LAMA/LABA)	Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid 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 (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