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Also known as: 753498-25-8, Arcapta neohaler, Indacaterol (maleate), Indacterol maleate, Indacaterol maleate [usan], Qab149-afa
Molecular Formula
C28H32N2O7
Molecular Weight
508.6  g/mol
InChI Key
IREJFXIHXRZFER-PCBAQXHCSA-N
FDA UNII
2JEC1ITX7R

Indacaterol Maleate
1 2D Structure

Indacaterol Maleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;5-[(1R)-2-[(5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one
2.1.2 InChI
InChI=1S/C24H28N2O3.C4H4O4/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24;5-3(6)1-2-4(7)8/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29);1-2H,(H,5,6)(H,7,8)/b;2-1-/t22-;/m0./s1
2.1.3 InChI Key
IREJFXIHXRZFER-PCBAQXHCSA-N
2.1.4 Canonical SMILES
CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CCC1=C(C=C2CC(CC2=C1)NC[C@@H](C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
2JEC1ITX7R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1h-quinolin-2-one

2. Arcapta Neohaler

3. Indacaterol

4. Onbrez

5. Qab-149

2.3.2 Depositor-Supplied Synonyms

1. 753498-25-8

2. Arcapta Neohaler

3. Indacaterol (maleate)

4. Indacterol Maleate

5. Indacaterol Maleate [usan]

6. Qab149-afa

7. Qab-149-afa

8. Indacaterol (as Maleate)

9. 2jec1itx7r

10. Chebi:68573

11. 753498-25-8 (malate)

12. Qabi49

13. (r)-5-(2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8-hydroxyquinolin-2(1h)-one Maleate

14. Qab-149 Maleate

15. Unii-2jec1itx7r

16. Qab 149afa

17. Oslif Breezhaler

18. Onbrez Breezhaler

19. Hirobriz Breezhaler

20. (r)-5-[2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1h)-one Maleate

21. Arcapta Neohaler (tn)

22. Onbrez Inhalation Capsules

23. Indacaterol Maleic Acid Salt

24. Schembl523627

25. Chembl1789842

26. Indacaterol Maleate [mi]

27. Indacaterol Maleate (jan/usan)

28. Indacaterol Maleate [jan]

29. Hms3885o07

30. Indacaterol Maleate [mart.]

31. Hy-14299a

32. Indacaterol Maleate [who-dd]

33. Mfcd20526769

34. Indacaterol Maleate [ema Epar]

35. Ccg-269764

36. Indacaterol Maleate [orange Book]

37. Ac-30121

38. As-10152

39. Ultibro Component Indacaterol Maleate

40. I0927

41. Qva149 Component Indacaterol Maleate

42. S3083

43. Qva-149 Component Indacaterol Maleate

44. D09319

45. Indacaterol Maleate Component Of Utibron

46. Q27137018

47. (6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)pyrimidin-4-yl)amino)-2,2-dimethyl-3-oxo-2,3-dihydro-4h- Pyrido(3,2-b)-1,4-oxazin-4-yl)methyl Dihydrogen Phosphate

48. (z)-but-2-enedioic Acid;5-[(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1h-quinolin-2-one

49. 2(1h)-quinolinone, 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl )-8-hydroxy-, (2z)-2-butenedioate (1:1)

50. 2(1h)-quinolinone, 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8-hydroxy-, (2z)-2-butenedioate (1:1)

51. 435273-74-8

52. 5,6-diethyl-n-[(2r)-2-hydroxy-2-(8-hydroxy-2-oxo-1,2-dihydroquinolin-5-yl)ethyl]indan-2-aminium (2z)-3-carboxyacrylate

53. 5-((1r)-2-((5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino)-1-hydroxyethyl)-8- Hydroxyquinolin-2(1h)-one Hydrogen (2z)-2-butenedioate (salt)

54. 5-[(r)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1h-quinolin-2-one Maleate

55. 5-{(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl}-8-hydroxyquinolin-2(1h)-one (2z)-but-2-enedioate

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 508.6 g/mol
Molecular Formula C28H32N2O7
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count8
Rotatable Bond Count8
Exact Mass508.22095136 g/mol
Monoisotopic Mass508.22095136 g/mol
Topological Polar Surface Area156 Ų
Heavy Atom Count37
Formal Charge0
Complexity708
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameArcapta neohaler
PubMed HealthIndacaterol (By breathing)
Drug ClassesBronchodilator
Drug LabelARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALERinhaler. The inhalation powder is packaged in clear gelatin capsules.Each clear, hard gelatin capsule contains a dry powder blend...
Active IngredientIndacaterol maleate
Dosage FormPowder
RouteInhalation
Strengtheq 75mcg base
Market StatusPrescription
CompanyNovartis

2 of 2  
Drug NameArcapta neohaler
PubMed HealthIndacaterol (By breathing)
Drug ClassesBronchodilator
Drug LabelARCAPTA NEOHALER consists of a dry powder formulation of indacaterol maleate for oral inhalation only with the NEOHALERinhaler. The inhalation powder is packaged in clear gelatin capsules.Each clear, hard gelatin capsule contains a dry powder blend...
Active IngredientIndacaterol maleate
Dosage FormPowder
RouteInhalation
Strengtheq 75mcg base
Market StatusPrescription
CompanyNovartis

4.2 Drug Indication

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.


Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.


Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.


Chronic obstructive pulmonary disease


5 Pharmacology and Biochemistry
5.1 ATC Code

R03AC18


R03AC18


R03AC18


API Reference Price

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P-32M) (INDACATEROL MALEATE MICRONIZED)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.18","actualQuantity":"0.18","unit":"KGS","unitRateFc":"198000","totalValueFC":"39269.1","currency":"EUR","unitRateINR":"18166500","date":"24-Nov-2023","totalValueINR":"3269970","totalValueInUsd":"39269.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8910139","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1 08755 CASTELLBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703269800,"product":"INDACATEROL MALEATE API (140 GRAM) (BATCH NO. P-33M) (INDACATEROL MALEATE MICRONIZED)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.14","actualQuantity":"0.14","unit":"KGS","unitRateFc":"198000","totalValueFC":"30752.6","currency":"EUR","unitRateINR":"18285300","date":"23-Dec-2023","totalValueINR":"2559942","totalValueInUsd":"30752.6","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9375491","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1 08755 CASTELLBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717698600,"product":"INDACATEROL MALEATE MICRONIZED (BATCH NO. P-33M) (INDACATEROL MALEATE)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"198000","totalValueFC":"5481.9","currency":"EUR","unitRateINR":"18305100","date":"07-Jun-2024","totalValueINR":"457627.5","totalValueInUsd":"5481.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3878310","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1 08755 CASTELLBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
20-Jan-2021
22-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH

USFDA APPLICATION NUMBER - 207930

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DOSAGE - POWDER;INHALATION - EQ 75MCG BASE

USFDA APPLICATION NUMBER - 22383

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Global Sales Information

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Annual Reports

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01

Brand Name : Ultibro Group

Indacaterol

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Group

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2020 Revenue in Millions : 623

2019 Revenue in Millions : 630

Growth (%) : -1

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02

Brand Name : Ultibro Group

Indacaterol

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Group

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol

Main Therapeutic Indication : Respiratory Diseases

Currency : USD

2022 Revenue in Millions : 479

2021 Revenue in Millions : 584

Growth (%) : -18

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03

Brand Name : Onbrez Breezhaler

Indacaterol Maleate

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Onbrez Breezhaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol Maleate

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2014 Revenue in Millions : 14.60%

2013 Revenue in Millions :

Growth (%) :

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04

Brand Name : Ultibro Breezhaler

Indacaterol / Glycopyrronium Bromide

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Breezhaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol / Glycopyrronium Bromide

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2014 Revenue in Millions : 1866.70%

2013 Revenue in Millions :

Growth (%) :

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05

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Indacaterol Maleate

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol Maleate

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2015 Revenue in Millions : 220

2014 Revenue in Millions : 166

Growth (%) : -25%

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06

Brand Name : Ultibro Breezhaler

Indacaterol And Glycopyrronium Bromide

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Breezhaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol And Glycopyrronium Bromide

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2016 Revenue in Millions : 363

2015 Revenue in Millions : 260

Growth (%) : 40

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07

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Indacaterol Maleate

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol Maleate

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2016 Revenue in Millions : 143

2015 Revenue in Millions : 166

Growth (%) : -14

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08

Brand Name : Ultibro Breezhaler

Indacaterol and Glycopyrronium Bromide

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Breezhaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol and Glycopyrronium Bromide

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2017 Revenue in Millions : 411

2016 Revenue in Millions : 363

Growth (%) : 13

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09

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Indacaterol Maleate

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Onbrez Breezhaler/Arcapta Neohaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol Maleate

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2017 Revenue in Millions : 112

2016 Revenue in Millions : 143

Growth (%) : -22

blank

10

Brand Name : Ultibro Breezhaler

Indacaterol And Glycopyrronium Bromide

arrow
BioFlorida Conference
Not Confirmed

Brand Name : Ultibro Breezhaler

Switzerland
arrow
BioFlorida Conference
Not Confirmed

Indacaterol And Glycopyrronium Bromide

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2018 Revenue in Millions : 454

2017 Revenue in Millions : 411

Growth (%) : 10%

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