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Fosphenytoin Sodium

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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 9 USDMF, 4 EU WC, 4 NDC API, 6 Listed Suppliers, $ API Reference Price

14 API Suppliers
9 USDMF
4 EU WC
4 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers, 17 FDA Orange Book, 3 Europe, 1 Canada, 6 Listed Dossiers

27 FDF Dossiers
17 FDA Orange Book
3 Europe
1 Canada
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Pfanstiehl, 1 Actylis, 1 BioSpectra

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1 Pfanstiehl
1 Actylis
1 BioSpectra

EXCIPIENTS BY APPLICATIONS

3 Parenteral, 1 Topical

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3 Parenteral
1 Topical

DIGITAL CONTENT

3 NEWS #PharmaBuzz

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3 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 2 Finished Drug Prices

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2 US Medicaid Prescriptions
2 Finished Drug Prices

MARKET PLACE

5 APIs, 1 FDF Dossiers

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5 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents

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10 US Patents

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

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1 USP
1 Others

Fosphenytoin Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

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)

81,145

Annual Reports (USD Million)

Finished Drug Prices

4EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 92134-98-0, Fosphenytoin disodium salt, Cerebyx, Pro-epanutin, Ci 982, Ci-982

Molecular Formula

C₁₆H₁₃N₂Na₂O₆P

Molecular Weight

406.24 g/mol

InChI Key

GQPXYJNXTAFDLT-UHFFFAOYSA-L

FDA UNII

7VLR55452Z

Fosphenytoin Sodium is the sodium salt form of fosphenytoin, a prodrug that is hydrolyzed to the anticonvulsant phenytoin upon parental administration. Phenytoin exerts its effect most likely through an enhancement of sodium efflux from neurons in the motor cortex. This leads to a suppression of excessive neuronal firing and spread of seizure activity. Other physiologic effects from actions of phenytoin include modulation of the voltage-dependent calcium channels of neurons, inhibition of calcium flux across neuronal membranes and enhancement of sodium-potassium ATPase activity of neurons and glial cells. (NCI05)

1 2D Structure

Fosphenytoin Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

disodium;(2,5-dioxo-4,4-diphenylimidazolidin-1-yl)methyl phosphate

2.1.2 InChI

InChI=1S/C16H15N2O6P.2Na/c19-14-16(12-7-3-1-4-8-12,13-9-5-2-6-10-13)17-15(20)18(14)11-24-25(21,22)23;;/h1-10H,11H2,(H,17,20)(H2,21,22,23);;/q;2*+1/p-2

2.1.3 InChI Key

GQPXYJNXTAFDLT-UHFFFAOYSA-L

2.1.4 Canonical SMILES

C1=CC=C(C=C1)C2(C(=O)N(C(=O)N2)COP(=O)([O-])[O-])C3=CC=CC=C3.[Na+].[Na+]

2.2 Other Identifiers

2.2.1 UNII

7VLR55452Z

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3-(hydroxymethyl)phenytoin Disodium Phosphate

2. 3-(hydroxymethyl)phenytoin Phosphate Ester

3. Acc 9653

4. Acc-9653

5. Cerebyx

6. Fosphenytoin

7. Fosphenytoin, Disodium Salt

8. Hmpdp

9. Prodilantin

2.3.2 Depositor-Supplied Synonyms

1. 92134-98-0

2. Fosphenytoin Disodium Salt

3. Cerebyx

4. Pro-epanutin

5. Ci 982

6. Ci-982

7. Fosphenytoin (sodium)

8. Acc-9653

9. Acc-9653-010 (sodium Salt)

10. Disodium;(2,5-dioxo-4,4-diphenylimidazolidin-1-yl)methyl Phosphate

11. Fosphenytoin (disodium)

12. 3-(hydroxymethyl)-5,5-diphenylhydantoin, Disodium Phosphate (ester)

13. 7vlr55452z

14. 92134-98-0 (sodium)

15. Acc-9653-010

16. 2,4-imidazolidinedione, 5,5-diphenyl-3-((phosphonooxy)methyl)-, Disodium Salt

17. Fosphenytoin Disodium

18. Sodium (2,5-dioxo-4,4-diphenylimidazolidin-1-yl)methyl Phosphate

19. Fosphenytoinsodium

20. Acc 9653

21. Fosphenytoin Sodium [usan]

22. Fosphenytoin_sodium

23. Fosphenytoin Disodium Salt Hydrate

24. Acc 9653-010

25. Fostoin

26. Unii-7vlr55452z

27. Fosphenytoin Sodium [usan:usp]

28. Phosphenytoin Sodium

29. Cerebyx (tn)

30. Fosphenytoin Sodium Salt

31. Chembl919

32. Fosphenytoin Sodium (usp)

33. Schembl119417

34. Npc-06

35. Dtxsid1044271

36. Fosphenytoin Sodium [vandf]

37. Bcp13859

38. Fosphenytoin Sodium [mart.]

39. Disodium,(2,5-dioxo-4,4-diphenylimidazolidin-1-yl)methyl Phosphate

40. Fosphenytoin Sodium [usp-rs]

41. Fosphenytoin Sodium [who-dd]

42. 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione Disodium Salt

43. Akos015915510

44. Ac-1705

45. Fosphenytoin Disodium Salt [mi]

46. Fosphenytoin Sodium [orange Book]

47. Fosphenytoin Sodium [usp Impurity]

48. Fosphenytoin Sodium [usp Monograph]

49. Db-057291

50. Ft-0630980

51. D02096

52. D81920

53. A844152

54. Acc 9653 Pound>>acc9653 Pound>>acc-9653

55. Q27268914

56. Disodium (2,5-dioxo-4,4-diphenyl-1-imidazolidinyl)methyl Phosphate

57. Disodium [2,5-bis(oxidanylidene)-4,4-diphenyl-imidazolidin-1-yl]methyl Phosphate

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₁₃N₂Na₂O₆P
Molecular Weight	406.24 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	4
Exact Mass	406.03066170 g/mol
Monoisotopic Mass	406.03066170 g/mol
Topological Polar Surface Area	122 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	536
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Cerebyx
PubMed Health	fosphenytoin
Drug Classes	Anticonvulsant
Drug Label	CEREBYX (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equiv...
Active Ingredient	Fosphenytoin sodium
Dosage Form	Injectable

2 of 4
Drug Name	Fosphenytoin sodium
PubMed Health	fosphenytoin
Drug Label	Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin.1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents...
Active Ingredient	Fosphenytoin sodium
Dosage Form	Injectable

3 of 4
Drug Name	Cerebyx
PubMed Health	fosphenytoin
Drug Classes	Anticonvulsant
Drug Label	CEREBYX (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equiv...
Active Ingredient	Fosphenytoin sodium
Dosage Form	Injectable

4 of 4
Drug Name	Fosphenytoin sodium
PubMed Health	fosphenytoin
Drug Label	Fosphenytoin Sodium Injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin.1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents...
Active Ingredient	Fosphenytoin sodium
Dosage Form	Injectable

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Sodium Channel Blockers

A class of drugs that act by inhibition of sodium influx through cell membranes. Blockade of sodium channels slows the rate and amplitude of initial rapid depolarization, reduces cell excitability, and reduces conduction velocity. (See all compounds classified as Sodium Channel Blockers.)

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cytochrome P450 1A2 Inducers [MoA]; Cytochrome P450 2B6 Inducers [MoA]; Cytochrome P450 2C19 Inducers [MoA]; Cytochrome P450 2C8 Inducers [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 2D6 Inducers [MoA]; Cytochrome P450 3A Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]

API SUPPLIERS

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USDMF

01

Chemwerth Inc

U.S.A

VMX

Attending

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Fosphenytoin Sodium Usp

GDUFA

DMF Review : Complete

Rev. Date : 2023-05-03

Pay. Date : 2023-03-30

DMF Number : 37565

Submission : 2023-03-20

Status : Active

Type : II

02

Cilag Ag

Switzerland

Antibody Engineering

Not Confirmed

03

Divis Laboratories Ltd

India

Antibody Engineering

Not Confirmed

Not Confirmed

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

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