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Indacaterol/glycopyrronium bromide

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Indacaterol/glycopyrronium bromide
Combination of

Indacaterol	Ultra-long-acting beta-adrenoceptor agonist
Glycopyrronium bromide	Muscarinic anticholinergic
Clinical data
Trade names	Ultibro Breezhaler, Utibron Neohaler, Xoterna Breezhaler
Pregnancy category	AU: B3
Routes of administration	Inhalation only
ATC code	R03AL04 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only^[1] UK: POM (Prescription only) US: ℞-only EU: Rx-only
Identifiers
CAS Number	444313-53-5^Y
PubChem CID	11564052
KEGG	D10505
CompTox Dashboard (EPA)	DTXSID60155126

Indacaterol/glycopyrronium bromide, sold under the brand name Ultibro Breezhaler among others, is a fixed-dose combination medication for inhalation consisting of the following two active ingredients:

Indacaterol maleate—an ultra-long-acting beta-adrenoceptor agonist (ultra-LABA);^[2]
Glycopyrronium bromide (glycopyrrolate)—a muscarinic anticholinergic.

Indacaterol maleate/glycopyrronium bromide is used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).^[3]

The drug is marketed by Novartis under the trade names Ultibro Breezhaler and Utibron Neohaler in Europe and the United States, respectively.^[3]^[4] In 2016, Novartis licensed its U.S. commercial rights for Seebri Neohaler and Utibron Neohaler to Sunovion Pharmaceuticals.^[5]

References[edit]

^ "Product monograph brand safety updates". Health Canada. 7 July 2016. Retrieved 3 April 2024.

^ Cazzola M, Matera MG, Lötvall J (July 2005). "Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease". Expert Opin Investig Drugs. 14 (7): 775–83. doi:10.1517/13543784.14.7.775. PMID 16022567. S2CID 11930383.

^ ^a ^b "Ultibro Breezhaler". medicines.org.uk. DataPharm. 3 February 2015. Retrieved 9 February 2015.

^ "Approval History: NDA 207930". DRUGS@FDA. US FDA. Retrieved 14 May 2016.

^ Faulkner, Sarah (22 December 2016). "Sunovion, Novartis ink licensing deal for inhaled COPD drugs". Drug Delivery Business.

Drugs for obstructive airway diseases: asthma/COPD (R03)

Adrenergics, inhalants

Short-acting β₂ agonists	Bitolterol Carbuterol Fenoterol Isoetarine Pirbuterol Procaterol Reproterol Rimiterol Salbutamol (albuterol)^#/Levosalbutamol (levalbuterol) Terbutaline Tulobuterol
Long-acting β₂ agonists	Bambuterol Clenbuterol Formoterol/Arformoterol Salmeterol Salmefamol
Ultra-long-acting β₂ agonists	Abediterol Carmoterol Indacaterol Olodaterol Vilanterol
Other	Epinephrine^# Hexoprenaline Isoprenaline (isoproterenol) Orciprenaline (metaproterenol)

Glucocorticoids

Anticholinergics/
muscarinic antagonist

Mast cell stabilizers

Xanthines

Eicosanoid inhibition

Leukotriene antagonists	Montelukast Pranlukast Zafirlukast
Arachidonate 5-lipoxygenase inhibitors	Zileuton
Thromboxane receptor antagonists	Ramatroban Seratrodast
Non-xanthine PDE4 inhibitors	Ibudilast Roflumilast