Sodium oxybate - Generic Drug Details

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-five 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.

Summary for sodium oxybate

International Patents:	58
US Patents:	25
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
		500MG/ML	SOLUTION;ORAL
		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

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	214755-003	May 1, 2023		RX	Yes	No			Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No			Y

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

International Patents for sodium oxybate

Country	Patent Number	Title	Estimated Expiration
China	109789096	具有经改善药代动力学的γ-羟基丁酸盐改进释放制剂 (MODIFIED RELEASE GAMMA-HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS)
Poland	3335708
South Korea	102239042

Supplementary Protection Certificates for sodium oxybate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121