Indacaterol/glycopyrronium bromide

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; UK: POM (Prescription only); US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	444313-53-5 ;
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

^ "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.

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

[pmid16022567-2] 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.

[:0-3] "Ultibro Breezhaler". medicines.org.uk. DataPharm. 3 February 2015. Retrieved 9 February 2015.

[4] "Approval History: NDA 207930". DRUGS@FDA. US FDA. Retrieved 14 May 2016.

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

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