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Last Updated: August 7, 2020

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Sodium oxybate - Generic Drug Details

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What are the generic drug 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   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
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
1912999 14C0076 France   Start Trial PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1499331 SPC/GB13/034 United Kingdom   Start Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
2203431 2015/009 Ireland   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1175904 2007C/048 Belgium   Start Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Moodys
Colorcon
Mallinckrodt
Johnson and Johnson

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