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Sodium oxybate - Generic Drug Details

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What are the generic sources for sodium oxybate and what is the scope of sodium oxybate patent protection?

Sodium oxybate is the generic ingredient in two branded drugs marketed by West-ward Pharms Int and Jazz Pharms, and is included in two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has thirty patent family members in seventeen countries.

There are one thousand four hundred and thirty-six drug master file entries for sodium oxybate. One supplier is listed for this compound.

Summary for sodium oxybate

International Patents:	30
US Patents:	18
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1436
Suppliers / Packagers:	1
Bulk Api Vendors:	27
Clinical Trials:	38
Patent Applications:	6,828
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium oxybate
DailyMed Link:	sodium oxybate at DailyMed

Pharmacology for sodium oxybate

Drug Class	Central Nervous System Depressant
Physiological Effect	Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Medical Subject Heading (MeSH) Categories for sodium oxybate

Adjuvants, Anesthesia

Anesthetics, Intravenous

Synonyms for sodium oxybate

4-Hydroxybuttersaeure natriumsalz

4-Hydroxybutyrate sodium

4-Hydroxybutyric acid monosodium salt

4-Hydroxybutyric acid sodium salt

502-85-2

7G33012534

AKOS006221428

ARONIS24196

Butanoic acid, 4-hydroxy-, monosodium salt

Butanoic acid, 4-hydroxy-, sodium salt

Butanoic acid, 4-hydroxy-, sodium salt (1:1)

Butyric acid, 4-hydroxy-, monosodium salt (8CI)

BUTYRIC ACID, 4-HYDROXY-, SODIUM SALT

C-33820

CAS-502-85-2

CC-34496

CCG-212465

CHEMBL1200682

CS-4796

D05866

DB-071156

DB09072

DEA No. 2012

DSSTox_CID_28866

DSSTox_GSID_48940

DSSTox_RID_83135

DTXSID3048940

EB 27

EINECS 207-953-3

FT-0626615

Gamma Hydroxybutyric Acid preparations

Gamma OH

gamma-Hydroxy sodium butyrate

gamma-Hydroxybutyrate sodium

gamma-Hydroxybutyrate sodium salt

gamma-Hydroxybutyric acid, sodium salt

GHB Sodium Salt (Sodium Gammahydroxybutyrate)

GHB|||Sodium oxybate

H-4040

HMS2091E15

HY-B1187

Hydroxybutyric acid monosodium salt

I14-30979

JZP-6

LS-48077

Natrium 4-hydroxybutyrat

NCGC00247714-01

NSC 84223

OR026282

OR114418

OR28769

Oxybate (sodium)

Oxybate sodium

SCHEMBL61823

sodium 4-hydroxybutanoate

Sodium 4-hydroxybutyrate

sodium gamma hydroxybutyric acid

Sodium gamma-hydroxybutyrate

Sodium gammahydroxybutyrate

Sodium Oxybate (Sodium 4-Hydroxybutanoate)

Sodium oxybate (USAN)

Sodium Oxybate [USAN]

Sodium Oxybutyrate

Sodium-4-hydroxybutyrate

sodium;4-hydroxybutanoate

SODIUM4-HYDROXYBUTYRATE

Somsanit

Tox21_112871

UNII-7G33012534

WY 3478

WY-3478

XYGBKMMCQDZQOZ-UHFFFAOYSA-M

Xyrem (TN)

US Patents and Regulatory Information for sodium oxybate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes			Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002	AA	RX	Yes	Yes			Y

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Non-Orange Book US Patents for sodium oxybate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,797,171	Sensitive drug distribution system and method
6,472,431	Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
8,461,203	Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
8,952,029	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters

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International Patents for sodium oxybate

Country	Document Number	Estimated Expiration
Canada	2902948
Australia	2059000
Hong Kong	1215539
World Intellectual Property Organization (WIPO)	2014134380
Canada	2355293

Supplementary Protection Certificates for sodium oxybate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
15/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204