Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Baxter

Last Updated: December 5, 2022

Sodium oxybate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

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

There are five drug master file entries for sodium oxybate. One supplier is listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for sodium oxybate

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

SponsorPhase
Centre Hospitalier Intercommunal de Toulon La Seyne sur MerPhase 4
Brigham and Women's HospitalEarly Phase 1
FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n de la Salud y la CienciaPhase 1

See all sodium oxybate clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing500MG/MLSOLUTION;ORAL
See Plans and PricingSee Plans and Pricing500MG/MLSOLUTION;ORAL
See Plans and PricingSee Plans and Pricing9GSUSPENSION;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 Strength NDA ANDAs Submitted Submissiondate
XYREM Oral Solution sodium oxybate 500 mg/mL 021196 1 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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for sodium oxybate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
UCB Pharma Ltd Xyrem sodium oxybate EMEA/H/C/000593
Treatment of narcolepsy with cataplexy in adult patients.
Authorised no no no 2005-10-13
D&A Pharma Hopveus sodium oxybate EMEA/H/C/004962
Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.,
Refused no no no 2020-07-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for sodium oxybate

Country Patent Number Title Estimated Expiration
Slovenia 3335708 See Plans and Pricing
Denmark 2961399 See Plans and Pricing
Denmark 3335708 See Plans and Pricing
Portugal 2961399 See Plans and Pricing
Mexico 2015011242 METODO DE ADMINISTRACION DE GAMMA HIDROXIBUTIRATO CON TRANSPORTES DE MONOCARBOXILATO. (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium oxybate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 CR 2020 00018 Denmark See Plans and Pricing PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1758590 LUC00029 Luxembourg See Plans and Pricing PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2932970 18C1043 France See Plans and Pricing PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
1856135 LUC00153 Luxembourg See Plans and Pricing PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
0186405 SPC/GB00/021 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Harvard Business School
Baxter
Mallinckrodt

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 verification 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.