Details for New Drug Application (NDA): 021196

NDA 021196 describes XYREM, which is a drug marketed by Jazz Pharms and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XYREM profile page.

The generic ingredient in XYREM is sodium oxybate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.

Summary for 021196

Tradename:	XYREM
Applicant:	Jazz Pharms
Ingredient:	sodium oxybate
Patents:	7

Pharmacology for NDA: 021196

Physiological Effect

Central Nervous System Depression Decreased Central Nervous System Organized Electrical Activity

Medical Subject Heading (MeSH) Categories for 021196

Adjuvants, Anesthesia

Anesthetics, Intravenous

Suppliers and Packaging for NDA: 021196

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XYREM	sodium oxybate	SOLUTION;ORAL	021196	NDA AUTHORIZED GENERIC	Hikma Pharmaceuticals USA Inc.	0054-9628	0054-9628-57	180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)
XYREM	sodium oxybate	SOLUTION;ORAL	021196	NDA	Jazz Pharmaceuticals, Inc.	68727-100	68727-100-01	180 mL in 1 BOTTLE, PLASTIC (68727-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	0.5GM/ML
Approval Date:	Jul 17, 2002	TE:	AA	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 26, 2025
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY
Regulatory Exclusivity Expiration:	Apr 26, 2026
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	10,213,400*PED	Patent Expiration:	Sep 15, 2033	Product Flag?		Substance Flag?		Delist Request?	Y

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