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Synopsis

Chemistry

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Also known as: Atomoxetine hcl, 82248-59-7, Tomoxetine hydrochloride, Strattera, (r)-tomoxetine hydrochloride, (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine hydrochloride
Molecular Formula
C17H22ClNO
Molecular Weight
291.8  g/mol
InChI Key
LUCXVPAZUDVVBT-UNTBIKODSA-N
FDA UNII
57WVB6I2W0

Atomoxetin Hydrochloride
A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
1 2D Structure

Atomoxetin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3R)-N-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C17H21NO.ClH/c1-14-8-6-7-11-16(14)19-17(12-13-18-2)15-9-4-3-5-10-15;/h3-11,17-18H,12-13H2,1-2H3;1H/t17-;/m1./s1
2.1.3 InChI Key
LUCXVPAZUDVVBT-UNTBIKODSA-N
2.1.4 Canonical SMILES
CC1=CC=CC=C1OC(CCNC)C2=CC=CC=C2.Cl
2.1.5 Isomeric SMILES
CC1=CC=CC=C1O[C@H](CCNC)C2=CC=CC=C2.Cl
2.2 Other Identifiers
2.2.1 UNII
57WVB6I2W0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 139603, Ly

2. Atomoxetine

3. Atomoxetine Hcl

4. Hcl, Atomoxetine

5. Hydrochloride, Atomoxetine

6. Ly 139603

7. N-methyl-gamma-(2-methylphenoxy)benzenepropanamine Hydrochloride

8. Strattera

9. Tomoxetine

10. Tomoxetine Hydrochloride, (+)-isomer - T351671

11. Tomoxetine Hydrochloride, (+-)-isomer

12. Tomoxetine Hydrochloride, (-)-isomer

2.3.2 Depositor-Supplied Synonyms

1. Atomoxetine Hcl

2. 82248-59-7

3. Tomoxetine Hydrochloride

4. Strattera

5. (r)-tomoxetine Hydrochloride

6. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine Hydrochloride

7. Atomoxetine, Hcl

8. Atomoxetine Hydrochloride [usan]

9. (r)-(-)-tomoxetine Hydrochloride

10. Ly 139603

11. Atomoxetine (hydrochloride)

12. Ly-139603

13. Atomoxetine (as Hydrochloride)

14. 57wvb6i2w0

15. (-)-n-methyl-3-phenyl-3-(o-tolyloxy)propylamine Hydrochloride

16. Chebi:331697

17. (r)-atomoxetine Hydrochloride

18. Nsc-759104

19. Dsstox_cid_24266

20. Dsstox_rid_80136

21. Dsstox_gsid_44266

22. Smr000469177

23. Cas-82248-59-7

24. Unii-57wvb6i2w0

25. (3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine;hydrochloride

26. Strattera (tn)

27. Mfcd06410992

28. Ncgc00016056-02

29. Chembl1702

30. Mls001401377

31. Mls002153176

32. Schembl122111

33. Atomoxetine Hcl [vandf]

34. Dtxsid2044266

35. Atomoxetine Hydrochloride- Bio-x

36. Atomoxetine Hydrochloride Solution

37. Ly 139603 Hcl

38. Hms3413c05

39. Hms3677c05

40. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-aminehydrochloride

41. (r)-tomoxetine Hydrochloride, Solid

42. Tox21_110292

43. Atomoxetine Hydrochloride (jan/usp)

44. Ly-139602 [(+)-isomer]

45. S3175

46. Atomoxetine Hydrochloride [mi]

47. (3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine Hydrochloride

48. Akos015920150

49. Benzenepropanamine, N-methyl-gamma-(2-methylphenoxy)-, Hydrochloride, (-)-

50. Tox21_110292_1

51. Atomoxetine Hydrochloride [jan]

52. Ccg-100874

53. Cs-1085

54. Ks-1223

55. Nc00124

56. Nsc 759104

57. Atomoxetine For Impurity A Identification

58. Atomoxetine Hydrochloride [mart.]

59. Ncgc00025345-02

60. Atomoxetine Hydrochloride [usp-rs]

61. Atomoxetine Hydrochloride [who-dd]

62. Bm164222

63. Hy-17385

64. Ly-135252

65. Am20060733

66. Sw197504-3

67. Atomoxetine Hydrochloride [ep Monograph]

68. Atomoxetine Hydrochloride [orange Book]

69. D02574

70. Atomoxetine Hydrochloride [usp Monograph]

71. 248t597

72. Sr-01000597779

73. Sr-01000763397

74. Sr-01000597779-1

75. Sr-01000763397-3

76. Q27225729

77. F0001-2408

78. Atomoxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

79. (r)-n-methyl-?-(2-methylphenoxy)-benzenepropanamine Hydrochloride

80. (r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine Hydrochloride

81. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)-propan-1-amine Hydrochloride

82. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine Hcl

83. (r)-(-)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine Hydrochloride

84. (r)-n-methyl-gamma-(2-methylphenoxy)-benzenepropanamine Hydrochloride

85. Atomoxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

86. Methyl-((r)-3-phenyl-3-o-tolyloxy-propyl)-amine Hydrochloride

87. Atomoxetine For Impurity A Identification, European Pharmacopoeia (ep) Reference Standard

88. Atomoxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

89. Atomoxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

90. Benzenepropanamine, N-methyl-.gamma.-(2-methylphenoxy)-, Hydrochloride, (-)

91. Atomoxetine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 291.8 g/mol
Molecular Formula C17H22ClNO
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count6
Exact Mass291.1389920 g/mol
Monoisotopic Mass291.1389920 g/mol
Topological Polar Surface Area21.3 Ų
Heavy Atom Count20
Formal Charge0
Complexity237
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAtomoxetine hydrochloride
Drug LabelSTRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by xray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The...
Active IngredientAtomoxetine hydrochloride
Dosage FormCapsule
Routeoral
Strength18mg; 100mg; 25mg; 60mg; 10mg; 80mg; 40mg
Market StatusTentative Approval
CompanyMylan Pharms; Glenmark Generics; Aurobindo Pharma Usa; Apotex; Dr Reddys Labs; Sandoz; Sun Pharma Global

2 of 4  
Drug NameStrattera
PubMed HealthAtomoxetine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelSTRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The m...
Active IngredientAtomoxetine hydrochloride
Dosage FormCapsule
RouteOral
Strength18mg; 25mg; 100mg; 60mg; 10mg; 80mg; 40mg
Market StatusPrescription
CompanyLilly

3 of 4  
Drug NameAtomoxetine hydrochloride
Drug LabelSTRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by xray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The...
Active IngredientAtomoxetine hydrochloride
Dosage FormCapsule
Routeoral
Strength18mg; 100mg; 25mg; 60mg; 10mg; 80mg; 40mg
Market StatusTentative Approval
CompanyMylan Pharms; Glenmark Generics; Aurobindo Pharma Usa; Apotex; Dr Reddys Labs; Sandoz; Sun Pharma Global

4 of 4  
Drug NameStrattera
PubMed HealthAtomoxetine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelSTRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The m...
Active IngredientAtomoxetine hydrochloride
Dosage FormCapsule
RouteOral
Strength18mg; 25mg; 100mg; 60mg; 10mg; 80mg; 40mg
Market StatusPrescription
CompanyLilly

4.2 Drug Indication

Treatment of Attention Deficit Hyperactivity Disorder (ADHD)


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Adrenergic Uptake Inhibitors

Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Norepinephrine Uptake Inhibitors [MoA]; Norepinephrine Reuptake Inhibitor [EPC]

API Reference Price

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ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1617733800,"product":"ATOMOXETINE RELATED COMPOUND B (QTY: 2 X 0.05GMS, PRICE: USD-76.28\/EACH)(FOC)","address":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,","city":"HYDERABAD-A.P.","supplier":"THE U.S PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"WASHINGTON DULLES I","customer":"UNITED STATES PHARMACOPEIA ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"1525600","totalValueFC":"158.3","currency":"USD","unitRateINR":"117853800","date":"07-Apr-2021","totalValueINR":"11785.38","totalValueInUsd":"158.3","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"3466098","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON DULLES I","supplierAddress":"","customerAddress":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630866600,"product":"ATOMOXETINE RELATED COMPOUND B (QTY : 1 X 10 MGS ,VALUE : USD 835)(FOC)","address":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,","city":"HYDERABAD-A.P.","supplier":"THE U.S. PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00001","unit":"KGS","unitRateFc":"83500000","totalValueFC":"857.4","currency":"USD","unitRateINR":"6306546000","date":"06-Sep-2021","totalValueINR":"63065.46","totalValueInUsd":"857.4","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"5334833","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630866600,"product":"ATOMOXETINE S-ISOMER (QTY : 1 X 0.2 GMS ,VALUE : USD 218.91)(FOC)","address":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,","city":"HYDERABAD-A.P.","supplier":"THE U.S. PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1094550","totalValueFC":"224.8","currency":"USD","unitRateINR":"82668650","date":"06-Sep-2021","totalValueINR":"16533.73","totalValueInUsd":"224.8","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"5334833","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630866600,"product":"ATOMOXETINE S-ISOMER (QTY : 3 X 0.25 GMS ,VALUE : USD 271.11\/EACH)(FOC)","address":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,","city":"HYDERABAD-A.P.","supplier":"THE U.S. PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00075","unit":"KGS","unitRateFc":"1084440","totalValueFC":"835.1","currency":"USD","unitRateINR":"81905040","date":"06-Sep-2021","totalValueINR":"61428.78","totalValueInUsd":"835.1","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"5334833","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655058600,"product":"(RE-IMPORT) ATOMOXETINE HYDROCHLORIDE-BATCH NO.AM21030015-(QUALITY PURPOSE REJECTED)(SB NO-1851723 DT-18-05-21)","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"CBC GROUP","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1800","totalValueFC":"93183.4","currency":"USD","unitRateINR":"145394.6","date":"13-Jun-2022","totalValueINR":"7269731.25","totalValueInUsd":"93183.4","indian_port":"HYDERABAD AIR","hs_no":"29221190","bill_no":"9096922","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687717800,"product":"70042162, X3212348 ATOMOXETINE HYDROCHLORIDE CTM-MSN","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PATHEON","supplierCountry":"UNITED STATES","foreign_port":"N\/A","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1469.8","totalValueFC":"22276","currency":"USD","unitRateINR":"122066.9","date":"26-Jun-2023","totalValueINR":"1831003","totalValueInUsd":"22276","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29221990","bill_no":"1002700","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"2110 EAST GALBRAITH ROAD CINCINNATI , OHIO 45237-1625 United States","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688149800,"product":"ATOMOXETINE HCI","address":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"NA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"144.00","actualQuantity":"144","unit":"KGS","unitRateFc":"1050","totalValueFC":"152783","currency":"USD","unitRateINR":"87202.6","date":"01-Jul-2023","totalValueINR":"12557160.13","totalValueInUsd":"152783","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719772200,"product":"29221985 ATOMOXETINE HCL","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"310.90","actualQuantity":"310.9","unit":"KGS","unitRateFc":"980","totalValueFC":"307266","currency":"USD","unitRateINR":"82614","date":"01-Jul-2024","totalValueINR":"25684692.6","totalValueInUsd":"307266","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"4281210","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEIN BUILDING,PIET HEINKADE 1071019 GM AMSTERDAM THE NETHERLANDS, NETHERLANDS","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727980200,"product":"7035100 ATOMOXETINE HCL","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"TEVA API","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"403.87","actualQuantity":"403.87","unit":"KGS","unitRateFc":"980","totalValueFC":"399671.3","currency":"USD","unitRateINR":"83153","date":"04-Oct-2024","totalValueINR":"33583002.11","totalValueInUsd":"399671.3","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"5953032","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 107 1019 GM AMSTERDAM THE NETHERLANDS, NETHERLANDS","customerAddress":"206, DEVAVRATA,"}]
07-Jan-2021
28-Nov-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

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Total Value (USD)

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

API Imports and Exports

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Drugs in Development

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Details:

AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic. It is being evaluated in phase 3 clinial trials for treating obstructive sleep apnea.


Lead Product(s): Oxybutynin,Atomoxetin Hydrochloride

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 19, 2024

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01

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic. It is being evaluated in phase 3 clinial trials for treating obstructive sleep apnea.

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 19, 2024

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Details:

AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective NRI, atomoxetine. It is being evaluated for the treatment of obstructive sleep apnea.


Lead Product(s): Oxybutynin,Atomoxetin Hydrochloride

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2024

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02

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective NRI, atomoxetine. It is being evaluated for the treatment of obstructive sleep apnea.

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 09, 2024

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Details:

AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep Apnea.


Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2023

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03

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep ...

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 21, 2023

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Details:

AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.


Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2023

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04

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 21, 2023

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Details:

AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.


Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Alpha Wave Ventures

Deal Size: $79.7 million Upfront Cash: Undisclosed

Deal Type: Series C Financing January 03, 2023

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05

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Lead Product(s) : Atomoxetin Hydrochloride,Aroxybutynin

Therapeutic Area : Sleep

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Alpha Wave Ventures

Deal Size : $79.7 million

Deal Type : Series C Financing

Details : AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 03, 2023

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Details:

AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity.


Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 28, 2022

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06

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease s...

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 28, 2022

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Details:

AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], p=0.003 on AD504.


Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride

Therapeutic Area: Sleep Brand Name: AD504

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2022

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07

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], ...

Brand Name : AD504

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 02, 2022

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Details:

Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.


Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 09, 2022

blank

08

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 09, 2022

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Details:

AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.


Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride

Therapeutic Area: Sleep Brand Name: AD504

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 16, 2021

blank

09

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Details : AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.

Brand Name : AD504

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 16, 2021

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Details:

The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage Phase 2 clinical trials.


Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride

Therapeutic Area: Sleep Brand Name: AD109

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Morningside Ventures

Deal Size: $25.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing March 25, 2021

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10

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Apnimed

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Lead Product(s) : Aroxybutynin,Atomoxetin Hydrochloride

Therapeutic Area : Sleep

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Morningside Ventures

Deal Size : $25.0 million

Deal Type : Series B Financing

Details : The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage ...

Brand Name : AD109

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 25, 2021

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DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 21411

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Atomoxetine Hydrochloride Manufacturers

A Atomoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Atomoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Atomoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Atomoxetine Hydrochloride Suppliers

A Atomoxetine Hydrochloride supplier is an individual or a company that provides Atomoxetine Hydrochloride active pharmaceutical ingredient (API) or Atomoxetine Hydrochloride finished formulations upon request. The Atomoxetine Hydrochloride suppliers may include Atomoxetine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Atomoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Atomoxetine Hydrochloride USDMF

A Atomoxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Atomoxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Atomoxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Atomoxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Atomoxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Atomoxetine Hydrochloride USDMF includes data on Atomoxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atomoxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Atomoxetine Hydrochloride suppliers with USDMF on PharmaCompass.

Atomoxetine Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Atomoxetine Hydrochloride Drug Master File in Japan (Atomoxetine Hydrochloride JDMF) empowers Atomoxetine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Atomoxetine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Atomoxetine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Atomoxetine Hydrochloride suppliers with JDMF on PharmaCompass.

Atomoxetine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Atomoxetine Hydrochloride Drug Master File in Korea (Atomoxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atomoxetine Hydrochloride. The MFDS reviews the Atomoxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Atomoxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Atomoxetine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Atomoxetine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Atomoxetine Hydrochloride suppliers with KDMF on PharmaCompass.

Atomoxetine Hydrochloride CEP

A Atomoxetine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Atomoxetine Hydrochloride Certificate of Suitability (COS). The purpose of a Atomoxetine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomoxetine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomoxetine Hydrochloride to their clients by showing that a Atomoxetine Hydrochloride CEP has been issued for it. The manufacturer submits a Atomoxetine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomoxetine Hydrochloride CEP holder for the record. Additionally, the data presented in the Atomoxetine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomoxetine Hydrochloride DMF.

A Atomoxetine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomoxetine Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Atomoxetine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Atomoxetine Hydrochloride WC

A Atomoxetine Hydrochloride written confirmation (Atomoxetine Hydrochloride WC) is an official document issued by a regulatory agency to a Atomoxetine Hydrochloride manufacturer, verifying that the manufacturing facility of a Atomoxetine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atomoxetine Hydrochloride APIs or Atomoxetine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Atomoxetine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Atomoxetine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Atomoxetine Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Atomoxetine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Atomoxetine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Atomoxetine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Atomoxetine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atomoxetine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Atomoxetine Hydrochloride suppliers with NDC on PharmaCompass.

Atomoxetine Hydrochloride GMP

Atomoxetine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Atomoxetine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Atomoxetine Hydrochloride GMP manufacturer or Atomoxetine Hydrochloride GMP API supplier for your needs.

Atomoxetine Hydrochloride CoA

A Atomoxetine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Atomoxetine Hydrochloride's compliance with Atomoxetine Hydrochloride specifications and serves as a tool for batch-level quality control.

Atomoxetine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Atomoxetine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Atomoxetine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Atomoxetine Hydrochloride EP), Atomoxetine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atomoxetine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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