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Alendronate Sodium

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ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 10 EU WC, 13 KDMF, 11 NDC API, 20 Listed Suppliers, $ API Reference Price

49 API Suppliers
24 USDMF
13 CEP/COS
6 JDMF
10 EU WC
13 KDMF
11 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

232 FDF Dossiers, 64 FDA Orange Book, 107 Europe, 25 Canada, 6 Australia, 3 South Africa, 27 Listed Dossiers

232 FDF Dossiers
64 FDA Orange Book
107 Europe
25 Canada
6 Australia
3 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

drugProductComposition
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 70MG BASE
TABLET;ORAL - EQ 70MG BASE;2,800 IU
TABLET;ORAL - EQ 70MG BASE;5,600 IU

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 2 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 7 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 18 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 36 Direct Compression, 27 Disintegrants & Superdisintegrants, 23 Taste Masking, 20 Thickeners and Stabilizers, 20 Co-Processed Excipients, 19 Granulation, 15 Lubricants & Glidants, 14 Chewable & Orodispersible Aids, 8 Empty Capsules, 7 Coating Systems & Additives, 6 Parenteral, 6 Controlled & Modified Release, 4 API Stability Enhancers, 3 Emulsifying Agents, 2 Solubilizers, 2 Topical, 2 Rheology Modifiers, 1 Film Formers & Plasticizers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

media
5 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 120 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
4 US Medicaid Prescriptions
120 Finished Drug Prices
5 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

marketPlace
10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 17 Health Canada Patents

patents
1 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 4 JP , 1 Others

otherSolutions
2 EDQM
1 USP
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Alendronate Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 182

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

232

FDF Dossiers

FDA Orange Book

107

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS 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)

89,850,918

Annual Reports (USD Million)

1,188

Finished Drug Prices

193 RELATED EXCIPIENT COMPANIES

296EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 129318-43-0, Fosamax, Binosto, Fosamac, Onclast, Monosodium alendronate

Molecular Formula

C₄H₁₂NNaO₇P₂

Molecular Weight

271.08 g/mol

InChI Key

CAKRAHQRJGUPIG-UHFFFAOYSA-M

FDA UNII

4988K7X26P

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

1 2D Structure

Alendronate Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate

2.1.2 InChI

InChI=1S/C4H13NO7P2.Na/c5-3-1-2-4(6,13(7,8)9)14(10,11)12;/h6H,1-3,5H2,(H2,7,8,9)(H2,10,11,12);/q;+1/p-1

2.1.3 InChI Key

CAKRAHQRJGUPIG-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C(CC(O)(P(=O)(O)O)P(=O)(O)[O-])CN.[Na+]

2.2 Other Identifiers

2.2.1 UNII

4988K7X26P

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-amino-1-hydroxybutylidene 1,1-biphosphonate

2. Alendronate

3. Alendronate Monosodium Salt, Trihydrate

4. Aminohydroxybutane Bisphosphonate

5. Fosamax

6. Mk 217

7. Mk-217

8. Mk217

2.3.2 Depositor-Supplied Synonyms

1. 129318-43-0

2. Fosamax

3. Binosto

4. Fosamac

5. Onclast

6. Monosodium Alendronate

7. Alendronate Sodium Anhydrous

8. Alendronate Monosodium

9. Mk 217

10. Alendronic Acid Monosodium Salt

11. Mk-217

12. Sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate

13. Adrovance

14. Fosavance

15. G-704650

16. Vantavo

17. Onclast; Osteovan; Sodium Alendronate

18. 4988k7x26p

19. Osteovan

20. Indrol

21. Alend

22. Neobon

23. Alendronate (as Sodium)

24. Phosphonic Acid, (4-amino-1-hydroxybutylidene)bis-, Monosodium Salt

25. Nsc-722597

26. Nsc-758931

27. Almerol

28. Avalent

29. Bonalon

30. Steovess

31. Teiroc

32. Unii-4988k7x26p

33. Ahbutbp

34. Ahbubp

35. (4-amino-1-hydroxybutylidene)bisphosphonic Acid Monosodium Salt

36. Chembl675

37. Alendronic Acid Sodium Salt

38. Gth-42j

39. Gth-42v

40. Gth-42w

41. Schembl328770

42. Gth-42

43. Dtxsid70904501

44. Mer-103

45. Hms3604i12

46. Hms3713p04

47. Sodium Alendronate Anhydrous

48. Bcp28464

49. Alendronic Acid, Sodium Aldendronate

50. Bdbm50247920

51. Ex-101

52. Mfcd01861681

53. Akos015895071

54. Ccg-220631

55. Ks-1028

56. Mk-0217

57. Hy-108685

58. Cs-0029477

59. Mk 217;mk-217;mk217;sodium Alendronate

60. A805927

61. J-005667

62. L-670452

63. Q27259256

64. Monosodium (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate

65. Sodium Hydrogen-4-amino-1-hydroxy-1-phosphonobutylphosphonate

66. (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt

67. 4-amino-1-hydroxybutylidene-1,1-bisphosphonic Acid Monosodium Salt

68. P,p'-(4-amino-1-hydroxybutylidene)bis-phosphonic Acid Monosodium Salt

69. Phosphonic Acid, P,p'-(4-amino-1-hydroxybutylidene)bis-, Sodium Salt (1:1)

2.4 Create Date

2007-11-13

3 Chemical and Physical Properties

Molecular Formula	C₄H₁₂NNaO₇P₂
Molecular Weight	271.08 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	5
Exact Mass	270.99867000 g/mol
Monoisotopic Mass	270.99867000 g/mol
Topological Polar Surface Area	164 Å²
Heavy Atom Count	15
Formal Charge	0
Complexity	293
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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	Alendronate sodium
PubMed Health	Alendronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	FOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml
Market Status	Prescription
Company	Watson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane

2 of 6
Drug Name	Binosto
Drug Label	BINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chem...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet, effervescent
Route	Oral
Strength	eq 70mg base
Market Status	Prescription
Company	Mission Pharma

3 of 6
Drug Name	Fosamax
PubMed Health	Alendronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	FOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 70mg base; eq 70mg base/75ml
Market Status	Prescription
Company	Merck; Merck And

4 of 6
Drug Name	Alendronate sodium
PubMed Health	Alendronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	FOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 40mg base; eq 5mg base; eq 70mg base; eq 10mg base; eq 35mg base; eq 70mg base/75ml
Market Status	Prescription
Company	Watson Labs; Teva Pharms; Austarpharma; Apotex; Aurobindo Pharma; Cadista Pharms; Dr Reddys Labs; Cipla; Sun Pharma Global; Mylan; Roxane

5 of 6
Drug Name	Binosto
Drug Label	BINOSTO (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is chem...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet, effervescent
Route	Oral
Strength	eq 70mg base
Market Status	Prescription
Company	Mission Pharma

6 of 6
Drug Name	Fosamax
PubMed Health	Alendronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	FOSAMAX1 (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.Alendronate sodium is che...
Active Ingredient	Alendronate sodium
Dosage Form	Tablet; Solution
Route	Oral
Strength	eq 70mg base; eq 70mg base/75ml
Market Status	Prescription
Company	Merck; Merck And

4.2 Drug Indication

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Adrovance reduces the risk of vertebral and hip fractures.

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Fosavance reduces the risk of vertebral and hip fractures.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Bone Density Conservation Agents

Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Diphosphonates [CS]; Bisphosphonate [EPC]

5.3 ATC Code

M05BB03

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API Reference Price

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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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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**