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Last Updated: October 22, 2019

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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 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 nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has thirty-six patent family members in twenty countries.

There are one thousand four hundred and seventy-two drug master file entries for sodium oxybate. One supplier is listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for sodium oxybate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPhase 4
Brigham and Women's HospitalEarly Phase 1
University Hospital, MontpellierPhase 2/Phase 3

See all sodium oxybate clinical trials

Recent Litigation for sodium oxybate

Identify potential future generic entrants

District Court Litigation
Case NameDate
JAZZ PHARMACEUTICALS, INC. v. MALLINCKRODT PLC2018-01-02
CELGENE CORPORATION v. LOTUS PHARMACEUTICAL CO., LTD.2017-09-06
JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC.2015-02-20

See all sodium oxybate litigation

PTAB Litigation
PetitionerDate
RANBAXY INC2016-03-10
Amneal Pharmaceuticals LLC2016-02-02
Ranbaxy, Inc.2015-10-07

See all sodium oxybate litigation

Generic filers with tentative approvals for SODIUM OXYBATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MG/MLSOLUTION;ORAL
  Start Trial  Start Trial500MG/MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for sodium oxybate
Synonyms for sodium oxybate
.Gamma.-Hydroxy butyrate
.gamma.-Hydroxy sodium butyrate
.gamma.-Hydroxybutyrate sodium
.gamma.-Hydroxybutyric acid decomposition product
.gamma.-Hydroxybutyric acid monosodium salt
.gamma.-Hydroxybutyric acid, sodium salt
.gamma.-OH
3-carboxypropoxy acid
30470-15-6
30IW36W5B2
4 HB
4-03-00-00774 (Beilstein Handbook Reference)
4-hydroxy-butanoic acid
4-hydroxy-butyric acid
4-Hydroxyacid
4-Hydroxyalkanoic acid
4-Hydroxybutanoic acid
4-Hydroxybutanoic acid #
4-Hydroxybuttersaeure
4-Hydroxybuttersaeure natriumsalz
4-Hydroxybutyrate sodium
4-Hydroxybutyric acid
4-Hydroxybutyric acid monosodium salt
4-Hydroxybutyric acid sodium salt
4-Hydroxycarboxylic acid
4-OHB
502-85-2
52352-27-9
591-81-1
7G33012534
AA3E2AF0-AB7A-4A1E-A391-199C049D7162
AC1L1V58
AKOS006221428
AKOS022632618
Alcover
AN-8743
Anetamin
ARONIS24196
BDBM50023575
BRN 1720582
Butanoic acid, 4-hydroxy-
Butanoic acid, 4-hydroxy-, monosodium salt
Butanoic acid, 4-hydroxy-, sodium salt
Butanoic acid, 4-hydroxy-, sodium salt (1:1)
Butanoic acid, hydroxy-, homopolymer
Butanoic acid,4-(1-oxobutoxy)-
Butyric acid, 4-hydroxy-
Butyric acid, 4-hydroxy-, monosodium salt
Butyric acid, 4-hydroxy-, monosodium salt (8CI)
BUTYRIC ACID, 4-HYDROXY-, SODIUM SALT
C-33820
C00989
C01991
C4H8O3
CAS-502-85-2
CC-34496
CCG-212465
CHEBI:30830
CHEMBL1200682
CHEMBL1342
CS-4796
CTK4G5262
D05866
DB-071156
DB09072
DEA No. 2010
DEA No. 2012
DSSTox_CID_28866
DSSTox_GSID_48940
DSSTox_RID_83135
DTXSID2074740
DTXSID3048940
EB 27
EINECS 207-953-3
FT-0626615
Gam-OH
Gamma Hydroxybutyric Acid
Gamma Hydroxybutyric Acid preparations
Gamma OH
gamma-hydroxy butyrate
gamma-Hydroxy sodium butyrate
gamma-Hydroxybutanoic acid
gamma-Hydroxybutyrate
gamma-Hydroxybutyrate sodium
gamma-Hydroxybutyrate sodium salt
gamma-Hydroxybutyric acid
gamma-Hydroxybutyric acid, sodium salt
GHB
GHB Sodium Salt (Sodium Gammahydroxybutyrate)
GHB|||Sodium oxybate
GTPL4711
H-4040
HMS2091E15
HSDB 6927
HY-B1187
Hydroxybutyric acid monosodium salt
Hydroxybutyric acid-
I14-30979
Juice
JZP-6
Liquid Ecstasy
LMFA01050006
LS-46312
LS-48077
Natrium 4-hydroxybutyrat
NCGC00247714-01
NSC 84223
NSC84223
oxy-n-butyric acid
Oxybate
Oxybate (sodium)
Oxybate sodium
PDSP1_000342
PDSP2_000340
Poly(hydroxybuyric acid)
SBI-0206686.P002
SCHEMBL10786
SCHEMBL61823
SHB
SJZRECIVHVDYJC-UHFFFAOYSA-N
Sodium .gamma.-hydroxybutyrate
Sodium .gamma.-oxybutyrate
sodium 4-hydroxybutanoate
Sodium 4-hydroxybutyrate
sodium gamma hydroxybutyric acid
Sodium gamma-hydroxybutyrate
Sodium gamma-oxybutyrate
Sodium gammahydroxybutyrate
Sodium Oxybate (4-hydroxybutanoic acid)
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-30IW36W5B2
UNII-7G33012534
WY 3478
WY-3478
XYGBKMMCQDZQOZ-UHFFFAOYSA-M
Xyrem
Xyrem (TN)
ZINC1532805

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

Supplementary Protection Certificates for sodium oxybate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium   Start Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1948158 1690020-1 Sweden   Start 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
1912999 1490062-5 Sweden   Start Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2563920 CA 2019 00001 Denmark   Start Trial PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
0473687 SPC/GB98/030 United Kingdom   Start Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
2822954 LUC00083 Luxembourg   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca
McKinsey
McKesson
Moodys

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