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Drug ReportsOxybate
Xyrem(oxybate)
Lumryz, Xyrem, Xywav (oxybate) is a small molecule pharmaceutical. 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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Target
Variants
Financial
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Safety
Events Timeline
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3M
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Lumryz, Oxybate, Xyrem (discontinued: Oxybate)
Combinations
Xywav
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium oxybate
+
Magnesium oxybate
+
Potassium oxybate
+
Sodium oxybate
Tradename
Company
Number
Date
Products
XYWAVJazz PharmaceuticalsN-212690 RX2020-07-21
1 products, RLD, RS
Sodium oxybate
Tradename
Company
Number
Date
Products
LUMRYZAvadel PharmaceuticalsN-214755 RX2023-05-01
4 products, RLD
XYREMJazz PharmaceuticalsN-021196 RX2002-07-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lumryzNew Drug Application2025-04-10
n/aNDA authorized generic2022-10-04
sodium oxybateANDA2025-05-19
xyremNew Drug Application2025-07-01
xywavNew Drug Application2025-07-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cataplexy—D002385—
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
64 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FatigueD005221—R53.83———1—1
Chronic fatigue syndromeD015673EFO_0004540G93.31———1—1
SyndromeD013577—————1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NarcolepsyD009290EFO_0000614G47.41———12
CataplexyD002385——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOxybate
INN—
Description
4-hydroxybutyric acid is a 4-hydroxy monocarboxylic acid that is butyric acid in which one of the hydrogens at position 4 is replaced by a hydroxy group. It has a role as a general anaesthetic, a GHB receptor agonist, a sedative and a neurotoxin. It is a 4-hydroxy monocarboxylic acid and a hydroxybutyric acid. It is functionally related to a butyric acid. It is a conjugate base of a 4-hydroxybutyrate.
Classification
Small molecule
Drug classGABA analogue, GHB receptor agonists—GABA receptor agonist; Psycholeptic; Depressant; HypnoticSedative
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCCO
Identifiers
PDB—
CAS-ID591-81-1
RxCUI1546380
ChEMBL IDCHEMBL1342
ChEBI ID30830
PubChem CID10413
DrugBankDB01440
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
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Xyrem – Jazz Pharmaceuticals
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Xywav – Jazz Pharmaceuticals
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Oxybate – Jazz Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,763 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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72,990 adverse events reported
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