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AboutPricing
Drug ReportsSodium oxybate
Sodium oxybate
Lumryz, Xyrem, Xywav (sodium oxybate) is a small molecule pharmaceutical. Sodium oxybate was first approved as Xyrem on 2002-07-17. It is used to treat cataplexy in the USA. It has been approved in Europe to treat cataplexy and narcolepsy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
lumryzNew Drug Application2025-04-10
n/aNDA authorized generic2022-10-04
sodium oxybateNDA authorized generic2023-04-25
xyremNew Drug Application2023-04-25
xywavNew Drug Application2023-04-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
SODIUM OXYBATE, LUMRYZ, AVADEL CNS
2030-05-01ODE-431
2026-05-01NP
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ
2028-08-12ODE-369
2027-07-21ODE-361
2024-08-12I-870
2023-07-21NP
SODIUM OXYBATE, XYREM, JAZZ PHARMS
2026-04-26PED
2025-10-26ODE-231
Patent Expiration
Patent
Expires
Flag
FDA Information
Sodium Oxybate, Lumryz, Avadel Cns
115835102042-02-07U-3578
109258442040-02-28DP
102720622037-07-21DP
107368662037-07-21DP
109529862037-07-21U-3601
109737952037-07-21DP
110004982037-07-21DPU-3580
110520612037-07-21DP
110652242037-07-21DP
114000652037-07-21U-3579
115043472037-07-21DP
116025122037-07-21U-3577
116025132037-07-21U-3576
Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz
114263732037-09-19U-3432
87723062033-03-15U-1532, U-3198
90503022033-03-15U-1532
94864262033-03-15U-1532
102134002033-03-15U-2499
108641812033-03-15U-1532, U-3017
112534942033-03-15U-3323, U-3324
85919222033-01-11DP
89011732033-01-11DP
91321072033-01-11DP
101951682033-01-11DP
106752582033-01-11U-2938
115541022033-01-11DP
Sodium Oxybate, Xyrem, Jazz Pharms
76687302024-06-16U-1110
ATC Codes
N: Nervous system drugs
— N01: Anesthetics
— N01A: Anesthetics, general
— N01AX: Other general anesthetics in atc
— N01AX11: Sodium oxybate
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX04: Sodium oxybate
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NarcolepsyD009290EFO_0000614G47.4——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSodium oxybate
INN—
Description
Sodium oxybate, sold under the brand name Xyrem or Alcover among others, is a medication used to treat three symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness and alcohol dependence. It is used sometimes in France and Italy as an anesthetic given intravenously;: 15, 27–28  it is also approved and used in Italy and in Austria to treat alcohol dependence and alcohol withdrawal syndrome.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
O=C([O-])CCCO.[Na+]
Identifiers
PDB—
CAS-ID502-85-2
RxCUI—
ChEMBL IDCHEMBL1200682
ChEBI ID—
PubChem CID23663870
DrugBankDB09072
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xyrem – Jazz Pharmaceuticals
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Xywav – Jazz Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,410 documents
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Safety
Black-box Warning
Black-box warning for: Lumryz, N/a, Sodium oxybate, Xyrem, Xywav
Adverse Events
Top Adverse Reactions
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74,279 adverse events reported
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