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Last Updated: March 18, 2024

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 three branded drugs marketed by Avadel Cns, Hikma, and Jazz Pharms, and is included in three NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium oxybate has fifty-eight patent family members in twenty-three countries.

There are five drug master file entries for sodium oxybate. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for sodium oxybate

See drug prices for sodium oxybate

Recent Clinical Trials for sodium oxybate

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

SponsorPhase
Mayo ClinicPhase 4
Centre Hospitalier Intercommunal de Toulon La Seyne sur MerPhase 4
Brigham and Women's HospitalEarly Phase 1

See all sodium oxybate clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial500MG/MLSOLUTION;ORAL
⤷  Try a Trial⤷  Try a 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 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
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-004 May 1, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-001 May 1, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-003 May 1, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avadel Cns LUMRYZ sodium oxybate FOR SUSPENSION, EXTENDED RELEASE;ORAL 214755-002 May 1, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 3930702 COMPOSITIONS DE GAMMA-HYDROXYBUTYRATE PRÉSENTANT UNE PHARMACOCINÉTIQUE AMÉLIORÉE À L'ÉTAT ALIMENTÉ (GAMMA-HYDROXYBUTYRATE COMPOSITIONS HAVING IMPROVED PHARMACOKINETICS IN THE FED STATE) ⤷  Try a Trial
European Patent Office 3695833 ADMINISTRATION DE GAMMA HYDROXYBUTYRATE ET DE TRANSPORTEURS MONOCARBOXYLATE (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS) ⤷  Try a Trial
China 114515273 具有经改善药代动力学的γ-羟基丁酸盐改进释放制剂 (Improved release formulations of gamma-hydroxybutyrate with improved pharmacokinetics) ⤷  Try a Trial
Croatia P20200215 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium oxybate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 LUC00195 Luxembourg ⤷  Try a Trial PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1499331 13C0055 France ⤷  Try a Trial PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1856135 2020/017 Ireland ⤷  Try a Trial 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; REGISTRATION NO/DATE: EU/1/19/1405 20200113
2203431 1590018-6 Sweden ⤷  Try a Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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