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

Sodium oxybate has forty-seven 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.

Summary for sodium oxybate

International Patents:	47
US Patents:	9
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1472
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	45
Patent Applications:	7
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for sodium oxybate

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

Sponsor	Phase
Avadel	Phase 3
Fundacio Lluita Contra la SIDA	Phase 1
Stanford University	Phase 4

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

Anatomical Therapeutic Chemical (ATC) Classes for sodium oxybate

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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		RX	Yes	Yes
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196-001	Jul 17, 2002		RX	Yes	Yes					Y

International Patents for sodium oxybate

Country	Patent Number	Estimated Expiration
Japan	2002533388
Lithuania	3335708
Portugal	3335708

Supplementary Protection Certificates for sodium oxybate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1499331	SPC/GB13/034	United Kingdom		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
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217