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Noramco Gamma Hydroxybutyric Acid Sodium

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ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 8 USDMF, 3 EU WC, 5 NDC API, 8 Listed Suppliers, $ API Reference Price

13 API Suppliers
8 USDMF
3 EU WC
5 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 9 FDA Orange Book, 6 Europe, 2 Canada, 2 Listed Dossiers

19 FDF Dossiers
9 FDA Orange Book
6 Europe
2 Canada
2 Listed Dossiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 54 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
54 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices, 9 Annual Reports

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1 US Medicaid Prescriptions
3 Finished Drug Prices
9 Annual Reports

MARKET PLACE

4 APIs

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4 APIs

PATENTS & EXCLUSIVITIES

138 US Patents, 18 US Exclusivities, 1 Health Canada Patents

patents
138 US Patents
18 US Exclusivities
1 Health Canada Patents

Noramco Gamma-Hydroxybutyric Acid Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

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NDC API

VMF

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API REF. PRICE (USD/KG)

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API

FDF

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

138

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)

156,545,926

Annual Reports (USD Million)

9,022

Finished Drug Prices

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Chemistry

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Also known as: 502-85-2, Sodium 4-hydroxybutyrate, Anetamin, 4-hydroxybutyric acid sodium salt, Sodium 4-hydroxybutanoate, Somsanit

Molecular Formula

C₄H₇NaO₃

Molecular Weight

126.09 g/mol

InChI Key

XYGBKMMCQDZQOZ-UHFFFAOYSA-M

FDA UNII

7G33012534

The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.

1 2D Structure

Sodium Oxybate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;4-hydroxybutanoate

2.1.2 InChI

InChI=1S/C4H8O3.Na/c5-3-1-2-4(6)7;/h5H,1-3H2,(H,6,7);/q;+1/p-1

2.1.3 InChI Key

XYGBKMMCQDZQOZ-UHFFFAOYSA-M

2.1.4 Canonical SMILES

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

2.2 Other Identifiers

2.2.1 UNII

7G33012534

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4 Hydroxybutyrate Sodium

2. 4-hydroxybutyrate Sodium

3. Gamma Hydroxybutyrate

4. Gamma-hydroxybutyrate

5. Oxybate Sodium

6. Oxybate, Sodium

7. Oxybutyrate, Sodium

8. Sodium Gamma Hydroxybutyrate

9. Sodium Gamma-hydroxybutyrate

10. Sodium Oxybutyrate

11. Somsanit

12. Xyrem

2.3.2 Depositor-Supplied Synonyms

1. 502-85-2

2. Sodium 4-hydroxybutyrate

3. Anetamin

4. 4-hydroxybutyric Acid Sodium Salt

5. Sodium 4-hydroxybutanoate

6. Somsanit

7. Oxybate Sodium

8. Gamma Oh

9. Sodium Oxybate [usan]

10. Sodium Oxybutyrate

11. Catabate

12. Sodium Oxybat

13. Oxybate (sodium)

14. 4-hydroxybutyrate Sodium

15. Wy-3478

16. Butanoic Acid, 4-hydroxy-, Monosodium Salt

17. Gamma-hydroxybutyrate Sodium

18. Sodium Gamma-hydroxybutyrate

19. Sodium;4-hydroxybutanoate

20. Gamma-hydroxy Sodium Butyrate

21. Butanoic Acid, 4-hydroxy-, Sodium Salt

22. Eb 27

23. Hydroxybutyric Acid Monosodium Salt

24. 4-hydroxybutyric Acid Monosodium Salt

25. Wy 3478

26. .gamma.-hydroxybutyrate Sodium Salt

27. Nsc-84223

28. Sodium Oxybate (usan)

29. 7g33012534

30. Butyric Acid, 4-hydroxy-, Monosodium Salt

31. Butyric Acid, 4-hydroxy-, Sodium Salt

32. Natrium 4-hydroxybutyrat

33. Sodium-4-hydroxybutyrate

34. Sodium Oxybate (sodium 4-hydroxybutanoate)

35. Ghb Sodium Salt (sodium Gammahydroxybutyrate)

36. 4-hydroxybuttersaeure Natriumsalz

37. Gamma-hydroxybutyrate Sodium Salt

38. Ncgc00247714-01

39. Einecs 207-953-3

40. Nsc 84223

41. Gamma-hydroxybutyric Acid, Sodium Salt

42. Jzp-6

43. Sodium4-hydroxybutyrate

44. Acetamide,2,2-dichloro-n-[(1r,2r)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-,rel-

45. Unii-7g33012534

46. Xyrem (tn)

47. Sodium Gammahydroxybutyrate

48. Dsstox_cid_28866

49. Dsstox_rid_83135

50. Dsstox_gsid_48940

51. Schembl61823

52. Sodium Oxybate [hsdb]

53. Sodium Oxybate [vandf]

54. Dea No. 2012

55. Sodium Oxybate [mart.]

56. Chembl1200682

57. Dtxsid3048940

58. Oxybate Sodium [who-dd]

59. Sodium Oxybate [ema Epar]

60. Hms2091e15

61. Hy-b1187

62. Tox21_112871

63. Sodium Oxybate [orange Book]

64. Gamma Hydroxybutyric Acid Preparations

65. Xywav Component Sodium Oxybate

66. Akos006221428

67. Ccg-212465

68. Cs-4796

69. Db09072

70. Sodium Oxybate Component Of Xywav

71. Cas-502-85-2

72. Db-071156

73. Ft-0626615

74. D05866

75. H-4040

76. Sodium Salt Of Gamma-hydroxybutyric Acid

77. .gamma.-hydroxybutyrate Sodium Salt [mi]

78. Butanoic Acid, 4-hydroxy-, Sodium Salt (1:1)

79. Q7553347

80. 90318-49-3

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₄H₇NaO₃
Molecular Weight	126.09 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	126.02928836 g/mol
Monoisotopic Mass	126.02928836 g/mol
Topological Polar Surface Area	60.4 Å²
Heavy Atom Count	8
Formal Charge	0
Complexity	64.3
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Xyrem
PubMed Health	Sodium Oxybate (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
Active Ingredient	Sodium oxybate
Dosage Form	Solution
Route	Oral
Strength	500mg/ml
Market Status	Prescription
Company	Jazz Pharms

2 of 2
Drug Name	Xyrem
PubMed Health	Sodium Oxybate (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
Active Ingredient	Sodium oxybate
Dosage Form	Solution
Route	Oral
Strength	500mg/ml
Market Status	Prescription
Company	Jazz Pharms

4.2 Drug Indication

For the treatment of cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.

FDA Label

Treatment of narcolepsy with cataplexy in adult patients.

Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended. ,

5 Pharmacology and Biochemistry

5.1 Pharmacology

Sodium oxybate works through an unknown mechanism to treat narcolepsy by inducing sleep within about 5-15 minutes of administration.

5.2 MeSH Pharmacological Classification

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

Anesthetics, Intravenous

Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Central Nervous System Depression [PE]; Decreased Central Nervous System Organized Electrical Activity [PE]; Central Nervous System Depressant [EPC]

5.4 ATC Code

N07XX04

N07BB

B05XA02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

N - Nervous system

N01 - Anesthetics

N01A - Anesthetics, general

N01AX - Other general anesthetics

N01AX11 - Sodium oxybate

N - Nervous system

N07 - Other nervous system drugs

N07X - Other nervous system drugs

N07XX - Other nervous system drugs

N07XX04 - Sodium oxybate

5.5 Absorption, Distribution and Excretion

Absorption

Absolute bioavailability is approximately 88%. Tmax of 30.7-51.9min.

Route of Elimination

The major metabolite is carbon dioxide which is cleared by expiration, less then 5% appears as the unchanged drug in the urine within 6-8 hours after dosing.

Volume of Distribution

Vd of 37.7-67.7

Clearance

Total clearance of 895-1361mL/min.

5.6 Metabolism/Metabolites

Animal studies indicate that the major elimination pathway is metabolism by the creation of carbon dioxide and water through the Krebs cycle and secondarily by beta-oxidation. In the primary pathway hydroxyacid-oxoacid transhydrogenase catalyzes the conversion of sodium oxybate to succinic semialdehyde which is then transformed to succinic acid by succinic semmialdehyde dehydrogenase. Succinic acid is then turned into carbon dioxide and water in the Krebs cycle. Succinic semialdehyde is also metabolised into carbon dioxide and water by a transhydrofenase in the presence of alpha ketoglutarate.

5.7 Biological Half-Life

0.5 to 1 hour.

5.8 Mechanism of Action

The exact mechanism of action is unknown. It is the sodium salt of the endogenous compound gamma hydroxybutyrate which is a metabolite of the GABA neurotransmitter and it's thought that it's therapeutic effects are mediated via GABA B actions at noradrenergic, dopaminergic and thalamocortical neurons.

API SUPPLIERS

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USDMF

01

Veranova Lp

U.S.A

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Veranova: A CDMO that manages complexity with confidence.

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U.S.A

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Sodium Oxybate Aqueous Concentrate

GDUFA

DMF Review : Complete

Rev. Date : 2022-04-25

Pay. Date : 2022-02-28

DMF Number : 36577

Submission : 2022-02-18

Status : Active

Type : II

02

Veranova Lp

U.S.A

DDL Conference

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

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U.S.A

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Sodium Oxybate

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-28

Pay. Date : 2012-12-19

DMF Number : 24049

Submission : 2010-08-02

Status : Active

Type : II

03

Alkem Laboratories Ltd

India

DDL Conference

Not Confirmed

Not Confirmed

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01

Rusan Pharma

India

Medlab Asia & Asia Health

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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India

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Sodium Oxybate

Date of Issue : 2021-08-27

Valid Till : 2024-06-10

Written Confirmation Number : WC-0278

Address of the Firm : Plot No. 6406, GIDC Estate, Ankleshwar-393002, Dist. Bharuch, Gujarat

02

Alkem Laboratories

India

Medlab Asia & Asia Health

Not Confirmed

03

Centaur Pharmaceuticals

India

Medlab Asia & Asia Health

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NDC API

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Listed Suppliers

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Noramco

U.S.A

Medlab Asia & Asia Health

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Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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Gamma-Hydroxybutyric Acid Sodium

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.

02

Veranova

U.S.A

Medlab Asia & Asia Health

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Sodium Oxybate

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.

03

Rusan Pharma

India

Medlab Asia & Asia Health

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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India

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Sodium Oxybate

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.

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Sodium Oxybate

About the Company : Farmak International is a leading GMP EU certified pharmaceutical manufacturer in Ukraine established in 1925 with FDA inspected site for production of food supplement. Company spe...

Farmak International is a leading GMP EU certified pharmaceutical manufacturer in Ukraine established in 1925 with FDA inspected site for production of food supplement. Company specialization is full-cycle production of finished dosage forms products for endocrinology, cardiology, rheumatology, ophthalmology and respiratory diseases; including anesthetics and radiopaque contrast media. Thanks to a strong research base and substantial investments in its production facilities, Farmak International possesses a considerable portfolio of high quality products and is open to cooperation, including but not limited to private labeling, in- and out-licensing, technologies transfers, R&D and contract manufacturing.

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08

OmnisMed Pharmaceuticals

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

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API Reference Price

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