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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Moodys
Covington
Queensland Health
US Department of Justice
Johnson and Johnson
Cantor Fitzgerald
McKesson
US Army

Generated: December 19, 2018

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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 fifty-four drug master file entries for sodium oxybate. One supplier is listed for this compound.

Medical Subject Heading (MeSH) Categories for sodium oxybate
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
West-ward Pharms Int SODIUM OXYBATE sodium oxybate SOLUTION;ORAL 202090-001 Jan 17, 2017 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for sodium oxybate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005 Belgium ➤ Try a Free Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C/GB06/021 United Kingdom ➤ Try a Free Trial PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
90020-1 Sweden ➤ Try a Free Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
C/GB07/011 United Kingdom ➤ Try a Free Trial PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Moodys
Covington
Queensland Health
US Department of Justice
Johnson and Johnson
Cantor Fitzgerald
McKesson
US Army

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