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Last Updated: June 11, 2024

SODIUM OXYBATE - Generic Drug Details

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What are the generic drug sources for sodium oxybate and what is the scope of freedom to operate?

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-nine 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.

Summary for SODIUM OXYBATE

International Patents:	59
US Patents:	24
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	50
Patent Applications:	159
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for SODIUM OXYBATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SODIUM OXYBATE
What excipients (inactive ingredients) are in SODIUM OXYBATE?	SODIUM OXYBATE excipients list
DailyMed Link:	SODIUM OXYBATE at DailyMed

See drug prices for SODIUM OXYBATE

Recent Clinical Trials for SODIUM OXYBATE

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

Sponsor	Phase
Mayo Clinic	Phase 4
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Phase 4
Brigham and Women's Hospital	Early Phase 1

See all SODIUM OXYBATE clinical trials

Generic filers with tentative approvals for SODIUM OXYBATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	500MG/ML	SOLUTION;ORAL
⤷ Sign Up	⤷ Sign Up	500MG/ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SODIUM OXYBATE

Drug Class	Central Nervous System Depressant
Physiological Effect	Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Medical Subject Heading (MeSH) Categories for SODIUM OXYBATE

Adjuvants, Anesthesia
Anesthetics, Intravenous

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

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Glossary

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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	214755-002	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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

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Country	Patent Number	Title	Estimated Expiration
Argentina	109376	FORMULACIONES DE g-HIDROXIBUTIRATO DE LIBERACIÓN MODIFICADA	⤷ Sign Up
Brazil	112021013766	Composições de gama-hidroxibutirato com farmacocinética melhorada no estado alimentado	⤷ Sign Up
Hong Kong	1256965	γ羥基丁酸與單羧酸轉運蛋白的施用 (ADMINISTRATION OF GAMMA HYDROXYBUTYRATE WITH MONOCARBOXYLATE TRANSPORTERS)	⤷ Sign Up
Canada	3028878	FORMULATIONS DE GAMMA-HYDROXYBUTYRATE A LIBERATION MODIFIEE AYANT UNE PHARMACOCINETIQUE AMELIOREE (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)	⤷ Sign Up
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)	⤷ Sign Up
Taiwan	201808273	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	⤷ Sign Up
Japan	6433440		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SODIUM OXYBATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2673237	LUC00111	Luxembourg	⤷ Sign Up	PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
2203431	92666	Luxembourg	⤷ Sign Up	PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
1874117	SPC/GB14/041	United Kingdom	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
1856135	CA 2020 00018	Denmark	⤷ Sign Up	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
2340828	LUC00195	Luxembourg	⤷ Sign Up	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
2465580	SPC/GB21/030	United Kingdom	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2203431	CR 2015 00014	Denmark	⤷ Sign Up	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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