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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Boehringer Ingelheim
UBS
Express Scripts
Queensland Health
Merck
McKinsey
Colorcon

Generated: August 14, 2018

DrugPatentWatch Database Preview

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.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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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 ➤ Sign Up
6,472,431 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy ➤ Sign Up
8,461,203 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy ➤ Sign Up
8,952,029 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for sodium oxybate

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
Healthtrust
Harvard Business School
Fuji
Fish and Richardson
Farmers Insurance
Queensland Health
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.