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XYREM Drug Profile

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When do Xyrem patents expire, and what generic alternatives are available?

Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium oxybate profile page.

Summary for XYREM

International Patents:	36
US Patents:	19
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Patent Applications:	5,809
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XYREM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYREM
DailyMed Link:	XYREM at DailyMed

See drug prices for XYREM

Recent Litigation for XYREM

Identify potential future generic entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS, INC. v. MALLINCKRODT PLC	2018-01-02
CELGENE CORPORATION v. LOTUS PHARMACEUTICAL CO., LTD.	2017-09-06
JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC.	2015-02-20

See all XYREM litigation

PTAB Litigation

Petitioner	Date
RANBAXY INC	2016-03-10
Amneal Pharmaceuticals LLC	2016-02-02
Ranbaxy, Inc.	2015-10-07

See all XYREM litigation

Pharmacology for XYREM

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

Synonyms for XYREM

.Gamma.-Hydroxy butyrate

.gamma.-Hydroxy sodium butyrate

.gamma.-Hydroxybutyrate sodium

.gamma.-Hydroxybutyric acid decomposition product

.gamma.-Hydroxybutyric acid monosodium salt

.gamma.-Hydroxybutyric acid, sodium salt

.gamma.-OH

3-carboxypropoxy acid

30470-15-6

30IW36W5B2

4 HB

4-03-00-00774 (Beilstein Handbook Reference)

4-hydroxy-butanoic acid

4-hydroxy-butyric acid

4-Hydroxyacid

4-Hydroxyalkanoic acid

4-Hydroxybutanoic acid

4-Hydroxybutanoic acid #

4-Hydroxybuttersaeure

4-Hydroxybutyrate sodium

4-Hydroxybutyric acid

4-Hydroxybutyric acid monosodium salt

4-Hydroxycarboxylic acid

4-OHB

52352-27-9

591-81-1

AA3E2AF0-AB7A-4A1E-A391-199C049D7162

AC1L1V58

AKOS022632618

Alcover

AN-8743

Anetamin

BDBM50023575

BRN 1720582

Butanoic acid, 4-hydroxy-

Butanoic acid, hydroxy-, homopolymer

Butanoic acid,4-(1-oxobutoxy)-

Butyric acid, 4-hydroxy-

Butyric acid, 4-hydroxy-, monosodium salt

C00989

C01991

C4H8O3

CHEBI:30830

CHEMBL1342

CTK4G5262

DEA No. 2010

DTXSID2074740

EB 27

Gam-OH

Gamma Hydroxybutyric Acid

Gamma OH

gamma-hydroxy butyrate

gamma-Hydroxybutanoic acid

gamma-Hydroxybutyrate

gamma-Hydroxybutyric acid

GHB

GTPL4711

HSDB 6927

Hydroxybutyric acid monosodium salt

Hydroxybutyric acid-

Juice

Liquid Ecstasy

LMFA01050006

LS-46312

NCGC00247714-01

NSC84223

oxy-n-butyric acid

Oxybate

Oxybate sodium

PDSP1_000342

PDSP2_000340

Poly(hydroxybuyric acid)

SBI-0206686.P002

SCHEMBL10786

SHB

SJZRECIVHVDYJC-UHFFFAOYSA-N

Sodium .gamma.-hydroxybutyrate

Sodium .gamma.-oxybutyrate

Sodium gamma-oxybutyrate

Sodium oxybate

Sodium Oxybate (4-hydroxybutanoic acid)

Somsanit

UNII-30IW36W5B2

WY 3478

WY-3478

ZINC1532805

US Patents and Regulatory Information for XYREM

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

Paragraph IV (Patent) Challenges for XYREM

Drugname	Dosage	Strength	RLD	Date
	Oral Solution	500 mg/mL

International Patents for XYREM

Country	Patent Number	Estimated Expiration
Japan	2009167189
Denmark	1140061
South Korea	20150125943
Hong Kong	1215539

Supplementary Protection Certificates for XYREM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220