indacaterol/glycopyrronium 110/50 Breezhaler® — Competitive Intelligence Brief

indacaterol/glycopyrronium 110/50 Breezhaler® (indacaterol/glycopyrronium 110/50 Breezhaler®) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination). Area: Respiratory / Pulmonology.

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

Target snapshot

indacaterol/glycopyrronium 110/50 Breezhaler® (indacaterol/glycopyrronium 110/50 Breezhaler®) — Wouter H. van Geffen. Indacaterol is a long-acting beta-2 agonist and glycopyrronium is an anticholinergic that together relax airway smooth muscle and reduce mucus secretion to improve airflow in chronic obstructive pulmonary disease.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
indacaterol/glycopyrronium 110/50 Breezhaler® TARGET	indacaterol/glycopyrronium 110/50 Breezhaler®	Wouter H. van Geffen	marketed	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor; Muscarinic M3 acetylcholine receptor
Anoro® Ellipta®	Anoro® Ellipta®	AstraZeneca	marketed	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor and M3 muscarinic acetylcholine receptor
Indacaterol/glycopyrronium	Indacaterol/glycopyrronium	Orion Corporation, Orion Pharma	marketed	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor; M3 muscarinic acetylcholine receptor
Olodaterol-Tiotropium	Olodaterol-Tiotropium	Fraunhofer-Institute of Toxicology and Experimental Medicine	marketed	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor; M3 muscarinic receptor
FF/GW642444 Inhalation Powder	FF/GW642444 Inhalation Powder	GlaxoSmithKline	phase 3	Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination)	Beta-2 adrenergic receptor; M3 muscarinic 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 beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) class)

1. AstraZeneca · 1 drug in this class
2. Fraunhofer-Institute of Toxicology and Experimental Medicine · 1 drug in this class
3. GlaxoSmithKline · 1 drug in this class
4. Orion Corporation, Orion Pharma · 1 drug in this class
5. Wouter H. van Geffen · 1 drug in this class