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Last Updated: July 2, 2020

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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 Hikma and Jazz Pharms, and is included in two NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has forty-one patent family members in twenty-three 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
Fundacio Lluita Contra la SIDAPhase 1
Stanford UniversityPhase 4
University Hospital, MontpellierPhase 2/Phase 3

See all sodium oxybate clinical trials

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
Paragraph IV (Patent) Challenges for SODIUM OXYBATE
Tradename Dosage Ingredient NDA Submissiondate
XYREM SOLUTION;ORAL sodium oxybate 021196 2010-07-08

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   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   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
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
0186405 SPC/GB00/021 United Kingdom   Start Trial PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
0145340 99C0005 Belgium   Start Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2932970 1890039-9 Sweden   Start Trial PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
2203431 92666 Luxembourg   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431 15C0013 France   Start Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
1912999 2014/058 Ireland   Start Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Harvard Business School
Baxter
Mallinckrodt

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