Indacaterol/glycopyrronium bromide

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/glycopyrronium bromide
Combination of
IndacaterolUltra-long-acting beta-adrenoceptor agonist
Glycopyrronium bromideMuscarinic anticholinergic
Clinical data
Trade namesUltibro Breezhaler, Utibron Neohaler, Xoterna Breezhaler
Pregnancy
category
  • AU: B3
Routes of
administration		Inhalation only
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Identifiers
CAS Number
PubChem CID
KEGG
CompTox Dashboard (EPA)

Indacaterol maleate/glycopyrronium bromide is used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).[2]

The drug is marketed by Novartis under the trade names Ultibro Breezhaler and Utibron Neohaler in Europe and the United States, respectively.[2][3] In 2016, Novartis licensed its U.S. commercial rights for Seebri Neohaler and Utibron Neohaler to Sunovion Pharmaceuticals.[4]

References
  1. 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.
  2. "Ultibro Breezhaler". medicines.org.uk. DataPharm. 3 February 2015. Retrieved 9 February 2015.
  3. "Approval History: NDA 207930". DRUGS@FDA. US FDA. Retrieved 14 May 2016.
  4. Faulkner, Sarah (22 December 2016). "Sunovion, Novartis ink licensing deal for inhaled COPD drugs". Drug Delivery Business.


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