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Risedronate Sodium

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 17 USDMF, 8 CEP/COS, 6 JDMF, 11 EU WC, 26 KDMF, 9 NDC API, 26 Listed Suppliers, $ API Reference Price

41 API Suppliers
17 USDMF
8 CEP/COS
6 JDMF
11 EU WC
26 KDMF
9 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

230 FDF Dossiers, 38 FDA Orange Book, 143 Europe, 4 Canada, 23 Australia, 5 South Africa, 17 Listed Dossiers

230 FDF Dossiers
38 FDA Orange Book
143 Europe
4 Canada
23 Australia
5 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG, TABLET;ORAL - 30MG, TABLET;ORAL - 35MG, TABLET;ORAL - 5MG, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 35MG

drugProductComposition
TABLET;ORAL - 150MG
TABLET;ORAL - 30MG
TABLET;ORAL - 35MG
TABLET;ORAL - 5MG
TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 35MG

DIGITAL CONTENT

10 NEWS #PharmaBuzz

media
10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 121 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
121 Finished Drug Prices
1 Annual Reports

MARKET PLACE

5 APIs

marketPlace
5 APIs

PATENTS & EXCLUSIVITIES

3 US Patents, 15 Health Canada Patents

patents
3 US Patents
15 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 3 JP , 4 Others

otherSolutions
3 EDQM
1 USP
3 JP
4 Others

Synnat Risedronate Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,044

MARKET PLACE

API

FDF

7INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

230

FDF Dossiers

FDA Orange Book

143

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

31,490,797

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Sodium risedronate, 115436-72-1, Actonel, Atelvia, Risedronate (sodium), Ne 58095

Molecular Formula

C₇H₁₀NNaO₇P₂

Molecular Weight

305.09 g/mol

InChI Key

DRFDPXKCEWYIAW-UHFFFAOYSA-M

FDA UNII

OFG5EXG60L

A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.

1 2D Structure

Risedronate Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate

2.1.2 InChI

InChI=1S/C7H11NO7P2.Na/c9-7(16(10,11)12,17(13,14)15)4-6-2-1-3-8-5-6;/h1-3,5,9H,4H2,(H2,10,11,12)(H2,13,14,15);/q;+1/p-1

2.1.3 InChI Key

DRFDPXKCEWYIAW-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1=CC(=CN=C1)CC(O)(P(=O)(O)O)P(=O)(O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

OFG5EXG60L

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-hydroxy-2-(3-pyridyl)ethylidene Diphosphonate

2. 2-(3-pyridinyl)-1-hydroxyethylidene-bisphosphonate

3. 2-(3-pyridinyl)-1-hydroxyethylidenebisphosphonate

4. Actonel

5. Atelvia

6. Bisphosphonate Risedronate Sodium

7. Risedronate

8. Risedronate Sodium, Bisphosphonate

9. Risedronic Acid

10. Risedronic Acid, Monosodium Salt

11. Sodium, Bisphosphonate Risedronate

2.3.2 Depositor-Supplied Synonyms

1. Sodium Risedronate

2. 115436-72-1

3. Actonel

4. Atelvia

5. Risedronate (sodium)

6. Ne 58095

7. Risedronic Acid Monosodium Salt

8. Risedronate Monosodium

9. Ofg5exg60l

10. Risedronate Sodium Anhydrous

11. Ne-58095 Anhydrous

12. Sodium Trihydrogen (1-hydroxy-2-(3-pyridyl)ethylidene)diphosphonate

13. 115436-72-1 (sodium)

14. Risedronic Acid Sodium

15. Benet

16. Nsc-722598

17. Nsc-759280

18. Actonel (tn)

19. Phosphonic Acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Monosodium Salt

20. Sodium Hydrogen (1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl)phosphonate

21. Risedronate Sodium [usan]

22. Risedronic Acid Sodium Salt

23. Mfcd00867080

24. 122458-82-6

25. Unii-ofg5exg60l

26. Optinate

27. Acrel

28. Risedronate Sodium [usan:usp]

29. Sodium Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate

30. Optinate Septimum

31. Monosodium Risedronate

32. Monosodium (1-hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonate

33. Ne 58095 Sodium

34. Risedronate Sodium (usp)

35. Chembl1654

36. Schembl18377

37. Risedronate Sodium, Min 97%

38. Chebi:8868

39. Dtxsid20924178

40. Risedronate Sodium [vandf]

41. Risedronate Sodium [mart.]

42. Act03362

43. Bcp22742

44. Hy-b0119

45. Risedronate Sodium [usp-rs]

46. Risedronate Sodium [who-dd]

47. Ac-732

48. Mfcd01706268

49. S1428

50. Akos015833432

51. Ab09807

52. Ccg-213235

53. Cs-1883

54. Nsc 722598

55. Nsc 759280

56. Risedronate Sodium [orange Book]

57. Ncgc00346521-01

58. Ac-20120

59. As-13309

60. Risedronate Sodium [usp Monograph]

61. Ft-0631078

62. M2289

63. Risedronic Acid Monosodium Salt [mi]

64. D00942

65. H11438

66. Ab01274790-01

67. Q-201723

68. Q27285633

69. 2-(3-pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate

70. Monosodium 1-hydroxy-2-(3-pyridyl)ethylidene-1,1-diphosphonate

71. 1-hydroxy-2-(3-pyridinyl) Ethylidene Bis-phosphonic Acid Monosodium Salt

72. Hydrogen [1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethyl]phosphonate (na+)

73. P,p'-[1-hydroxy-2-(3-pyridonyl)ethylidene]bis-phosphonic Acid Sodium Salt

74. Phosphonic Acid, (1-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Disodium Salt

75. Phosphonic Acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, Disodium Salt

76. Risedronate Sodium, United States Pharmacopeia (usp) Reference Standard

77. Risedronate Sodium;risedronic Acid Sodium;ne-58095; Ne 58095; Ne58095

78. Sodium Hydrogen-1-hydroxy-1-phosphono-2-(pyridin-3-yl)ethylphosphonate

79. Sodium;hydroxy-(1-hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphinate

80. (1-hydroxy-2-(pyridin-3-yl)ethane-1,1-diyl)bis(phosphonic Acid) Sodium Salt

81. Risedronate Sodium 2.5-hydrate, European Pharmacopoeia (ep) Reference Standard

82. Risedronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

83. 934544-85-1

2.4 Create Date

2005-09-13

3 Chemical and Physical Properties

Molecular Formula	C₇H₁₀NNaO₇P₂
Molecular Weight	305.09 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	4
Exact Mass	304.98301994 g/mol
Monoisotopic Mass	304.98301994 g/mol
Topological Polar Surface Area	151 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	375
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	Actonel
PubMed Health	Antacid, Calcium Containing (By mouth)
Drug Classes	Antacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement
Drug Label	ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet
Route	Oral
Strength	5mg; 30mg; 150mg; 35mg
Market Status	Prescription
Company	Warner Chilcott

2 of 6
Drug Name	Atelvia
Drug Label	Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet, delayed release
Route	Oral
Strength	35mg
Market Status	Prescription
Company	Warner Chilcott

3 of 6
Drug Name	Risedronate sodium
PubMed Health	Risedronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	30mg; 150mg; 75mg; 5mg; 35mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms

4 of 6
Drug Name	Actonel
PubMed Health	Antacid, Calcium Containing (By mouth)
Drug Classes	Antacid, Aluminum Containing, Antacid, Aluminum/Calcium/Magnesium Containing, Antacid, Calcium Containing, Antacid, Magnesium Containing, Antiflatulent, Calcium Supplement
Drug Label	ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet
Route	Oral
Strength	5mg; 30mg; 150mg; 35mg
Market Status	Prescription
Company	Warner Chilcott

5 of 6
Drug Name	Atelvia
Drug Label	Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet, delayed release
Route	Oral
Strength	35mg
Market Status	Prescription
Company	Warner Chilcott

6 of 6
Drug Name	Risedronate sodium
PubMed Health	Risedronate (By mouth)
Drug Classes	Calcium Regulator
Drug Label	ACTONEL (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anh...
Active Ingredient	Risedronate sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	30mg; 150mg; 75mg; 5mg; 35mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Apotex; Aurobindo Pharma; Teva Pharms Usa; Sun Pharma Global; Teva Pharms

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.)

Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Bisphosphonate [EPC]; Diphosphonates [CS]; Bisphosphonate [EPC]

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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 - 150MG