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ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 8 USDMF, 8 NDC API, 8 Listed Suppliers, $ API Reference Price

12 API Suppliers
8 USDMF
8 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 112 FDA Orange Book, 8 Europe

120 FDF Dossiers
112 FDA Orange Book
8 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 25MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 35MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 5MG

drugProductComposition
TABLET;ORAL - 10MG
TABLET;ORAL - 2.5MG
TABLET;ORAL - 5MG
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 25MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 35MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

5 Evonik, 4 SPI Pharma, 2 Seqens, 8 DKSH, 11 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 18 BASF, 2 Clariant, 21 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 7 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 5 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 50 Controlled & Modified Release, 28 Direct Compression, 27 Thickeners and Stabilizers, 19 Disintegrants & Superdisintegrants, 19 Granulation, 19 Taste Masking, 18 Lubricants & Glidants, 18 Film Formers & Plasticizers, 16 Solubilizers, 15 Co-Processed Excipients, 15 Topical, 9 Parenteral, 9 Empty Capsules, 6 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 API Stability Enhancers, 3 Rheology Modifiers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 36 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
4 US Medicaid Prescriptions
36 Finished Drug Prices
1 Annual Reports

MARKET PLACE

2 APIs

marketPlace
2 APIs

PATENTS & EXCLUSIVITIES

18 US Patents, 3 US Exclusivities, 6 Health Canada Patents

patents
18 US Patents
3 US Exclusivities
6 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,085

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

120

FDF Dossiers

112

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

29DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

2,876,740

Annual Reports (USD Million)

368

Finished Drug Prices

256 RELATED EXCIPIENT COMPANIES

434EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Dexmethylphenidate hcl, Focalin, D-threo-methylphenidate hydrochloride, 19262-68-1, Focalin xr, 23655-65-4

Molecular Formula

C₁₄H₂₀ClNO₂

Molecular Weight

269.77 g/mol

InChI Key

JUMYIBMBTDDLNG-OJERSXHUSA-N

FDA UNII

1678OK0E08

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

1 2D Structure

Dexmethylphenidate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate;hydrochloride

2.1.2 InChI

InChI=1S/C14H19NO2.ClH/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12;/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3;1H/t12-,13-;/m1./s1

2.1.3 InChI Key

JUMYIBMBTDDLNG-OJERSXHUSA-N

2.1.4 Canonical SMILES

COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl

2.1.5 Isomeric SMILES

COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2.Cl

2.2 Other Identifiers

2.2.1 UNII

1678OK0E08

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dexmethylphenidate

2. Focalin

3. Focalin Xr

4. Hydrochloride, Dexmethylphenidate

5. Xr, Focalin

2.3.2 Depositor-Supplied Synonyms

1. Dexmethylphenidate Hcl

2. Focalin

3. D-threo-methylphenidate Hydrochloride

4. 19262-68-1

5. Focalin Xr

6. 23655-65-4

7. Metadate Cd

8. Metadate Er

9. Equasym Xl

10. Dexmethylphenidate Hydrochloride [usan]

11. Ritalin

12. 4b3sc438hi

13. Dex-methylphenidate Hydrochloride

14. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-2-yl]acetate;hydrochloride

15. 1678ok0e08

16. Methylphenidate D-threo-form Hydrochloride

17. Methyl (2r)-phenyl((2r)-piperidin-2-yl)acetate Hydrochloride

18. 19262-68-1 (hcl)

19. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-1-ium-2-yl]acetate;chloride

20. Quillichew

21. Quillivant

22. Aptensio

23. Foquest

24. Oros Mph

25. Aptensio Xr

26. Methylin Er

27. Ritalin La

28. Ritalin Sr

29. Chembl904

30. (r)-methyl 2-phenyl-2-((r)-piperidin-2-yl)acetate Hydrochloride

31. Daytrana

32. Dexmethylphenidate Hydrochloride (usan)

33. Spd544

34. Spd-544

35. Dl-threo-methylphenidate Hcl

36. Biphentin

37. Equasym

38. Methypatch

39. Metadate Mr

40. Unii-1678ok0e08

41. Equasym Ir

42. Ritalin Qd

43. Focalin (tn)

44. Dl-threo-methylphenidate Hydrochloride

45. Adhansia Xr

46. Jornay Pm

47. Methyl .alpha.-phenyl-2-piperidineacetate Hydrochloride

48. Unii-4b3sc438hi

49. Nwp-06

50. Dtxsid50940927

51. D-threo Methylphenidate Hydrochloride

52. Akos027321667

53. Rac-threo-methylphenidate Hydrochloride

54. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (alphar,2r)-

55. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)- (+-)-

56. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r-(r*,r*))-

57. Methylphenidate Hydrochloride [mi]

58. (+/-)-threo-methylphenidate Hydrochloride

59. Methylphenidate Hydrochloride [jan]

60. Methylphenidate Hydrochloride [mart.]

61. Methylphenidate Hydrochloride [vandf]

62. Methylphenidate Hydrochloride [who-dd]

63. D03721

64. Dexmethylphenidate Hydrochloride [mart.]

65. Dexmethylphenidate Hydrochloride [vandf]

66. Dexmethylphenidate Hydrochloride [who-dd]

67. Methylphenidate Hydrochloride [orange Book]

68. Methylphenidate Hydrochloride Cii [usp-rs]

69. Methylphenidate Hydrochloride [ep Monograph]

70. Methylphenidate Hydrochloride [usp Monograph]

71. Dexmethylphenidate Hydrochloride [orange Book]

72. Methylphenidate D-threo-form Hydrochloride [mi]

73. Q47487562

74. Azstarys Component Dexmethylphenidate Hydrochloride

75. Dexmethylphenidate Hydrochloride Component Of Azstarys

76. Methyl Phenyl(piperidin-2-yl)acetate--hydrogen Chloride (1/1)

77. Methylphenidate Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

78. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+/-)-

79. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride,(.alpha.r,2r)-

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₂₀ClNO₂
Molecular Weight	269.77 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	269.1182566 g/mol
Monoisotopic Mass	269.1182566 g/mol
Topological Polar Surface Area	38.3 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	249
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Dexmethylphenidate hydrochloride
Drug Label	Focalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Tablet; Capsule, extended release
Route	oral; Oral
Strength	2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Watson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

2 of 6
Drug Name	Focalin
PubMed Health	Dexmethylphenidate (By mouth)
Drug Classes	CNS Stimulant
Drug Label	Focalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Novartis

3 of 6
Drug Name	Focalin xr
PubMed Health	Dexmethylphenidate (By mouth)
Drug Classes	CNS Stimulant
Drug Label	Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market Status	Prescription
Company	Novartis

4 of 6
Drug Name	Dexmethylphenidate hydrochloride
Drug Label	Focalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Tablet; Capsule, extended release
Route	oral; Oral
Strength	2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Watson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

5 of 6
Drug Name	Focalin
PubMed Health	Dexmethylphenidate (By mouth)
Drug Classes	CNS Stimulant
Drug Label	Focalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Novartis

6 of 6
Drug Name	Focalin xr
PubMed Health	Dexmethylphenidate (By mouth)
Drug Classes	CNS Stimulant
Drug Label	Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active Ingredient	Dexmethylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market Status	Prescription
Company	Novartis

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Dopamine Uptake Inhibitors

Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

Central Nervous System Stimulants

A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

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Europe

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21278

DOSAGE - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 21278

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21278

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG