Sodium oxybate - PharmaKB

Xyrem(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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Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
mental disorders	D001523

Trade Name

FDA

EMA

Lumryz, Xyrem

Combinations

Xywav

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Calcium oxybate

Magnesium oxybate

Potassium oxybate

Sodium oxybate

Tradename	Company	Number	Date	Products
XYWAV	Jazz Pharmaceuticals	N-212690 RX	2020-07-21	1 products, RLD, RS

Sodium oxybate

Tradename	Company	Number	Date	Products
LUMRYZ	AVADEL CNS	N-214755 RX	2023-05-01	4 products, RLD
XYREM	Jazz Pharmaceuticals	N-021196 RX	2002-07-17	1 products, RLD, RS

Labels

FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cataplexy	—	D002385	—

Agency Specific

FDA

EMA

Expiration	Code
SODIUM OXYBATE, LUMRYZ, AVADEL CNS
2030-05-01	ODE-431
2026-05-01	NP
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ
2028-08-12	ODE-369
2027-07-21	ODE-361
2024-08-12	I-870
2023-07-21	NP
SODIUM OXYBATE, XYREM, JAZZ PHARMS
2026-04-26	PED
2025-10-26	ODE-231

Patent Expiration

Patent	Expires	Flag	FDA Information
Sodium Oxybate, Lumryz, Avadel Cns
11583510	2042-02-07		U-3578
10925844	2040-02-28	DP
10272062	2037-07-21	DP
10736866	2037-07-21	DP
10952986	2037-07-21		U-3601
10973795	2037-07-21	DP
11000498	2037-07-21	DP	U-3580
11052061	2037-07-21	DP
11065224	2037-07-21	DP
11400065	2037-07-21		U-3579
11504347	2037-07-21	DP
11602512	2037-07-21		U-3577
11602513	2037-07-21		U-3576
Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz
11426373	2037-09-19		U-3432
8772306	2033-03-15		U-1532, U-3198
9050302	2033-03-15		U-1532
9486426	2033-03-15		U-1532
10213400	2033-03-15		U-2499
10864181	2033-03-15		U-1532, U-3017
11253494	2033-03-15		U-3323, U-3324
8591922	2033-01-11	DP
8901173	2033-01-11	DP
9132107	2033-01-11	DP
10195168	2033-01-11	DP
10675258	2033-01-11		U-2938
11554102	2033-01-11	DP
Sodium Oxybate, Xyrem, Jazz Pharms
7668730	2024-06-16		U-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

56 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Narcolepsy	D009290	HP_0030050	G47.4	3	—	8	4	3	18
Idiopathic hypersomnia	D020177	—	G47.11	—	1	1	2	—	3
Chronic fatigue syndrome	D015673	EFO_0004540	G93.31	—	—	—	3	—	3
Parkinson disease	D010300	EFO_0002508	G20	—	1	—	1	—	2
Alcoholism	D000437	EFO_0003829	F10.1	—	—	—	2	—	2
Rem sleep behavior disorder	D020187	EFO_0007462	G47.52	—	—	—	1	—	1
Obstructive sleep apnea	D020181	EFO_0003918	G47.33	—	—	—	1	—	1
Sleep	D012890	GO_0030431	—	—	—	—	1	—	1
Palliative care	D010166	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Fibromyalgia	D005356	EFO_0005687	M79.1	—	1	4	—	—	5
Cataplexy	D002385	HP_0002524	—	—	—	2	—	—	2
Disorders of excessive somnolence	D006970	—	G47.1	1	—	1	—	—	2
Sleep wake disorders	D012893	—	G47	—	—	1	—	—	1
Cluster headache	D003027	HP_0012199	G44.00	—	—	1	—	—	1
Binge-eating disorder	D056912	—	F50.2	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	2	—	—	—	2
Major depressive disorder	D003865	EFO_0003761	F22	—	1	—	—	1	2
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	—	—	—	1
Schizophrenia	D012559	EFO_0000692	F20	—	1	—	—	—	1
Essential tremor	D020329	EFO_0003108	G25.0	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv	D006678	—	O98.7	1	—	—	—	—	1
Traumatic brain injuries	D000070642	—	S06	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	—	—	—	—	1	1
Psychological trauma	D000067073	—	—	—	—	—	—	1	1
Physiological stress	D013312	—	—	—	—	—	—	1	1
Postoperative complications	D011183	—	—	—	—	—	—	1	1
Kidney transplantation	D016030	—	—	—	—	—	—	1	1
Incisional hernia	D000069290	HP_0004872	K43.2	—	—	—	—	1	1
Bipolar disorder	D001714	EFO_0000289	F30.9	—	—	—	—	1	1
Autistic disorder	D001321	HP_0000717	F84.0	—	—	—	—	1	1
Pregnancy rate	D018873	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Sodium 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	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O=C([O-])CCCO.[Na+]