Oxybate - PharmaKB

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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Clinical

Drug

Target

Variants

Financial

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
mental disorders	D001523

Trade Name

FDA

EMA

Lumryz, Xyrem (discontinued: Oxybate)

Combinations

Xywav

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sodium oxybate

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

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

Labels

FDA

EMA

Brand Name	Status	Last Update
lumryz	New Drug Application	2024-12-17
n/a	NDA authorized generic	2022-10-04
sodium oxybate	NDA authorized generic	2023-04-25
xyrem	New Drug Application	2023-04-25
xywav	New Drug Application	2023-04-25

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cataplexy	HP_0002524	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

No data

Drug

General

Drug common name	Oxybate
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 class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	O=C(O)CCCO