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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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in seventeen countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and thirty-six 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:	30
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	17
Patent Applications:	4,304
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYREM
DailyMed Link:	XYREM at DailyMed

Pharmacology for XYREM

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 XYREM

Adjuvants, Anesthesia

Anesthetics, Intravenous

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-Hydroxybutyric acid sodium 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, 4-hydroxy-, sodium salt

Butanoic acid,4-(1-oxobutoxy)-

Butyric acid, 4-hydroxy-

Butyric acid, 4-hydroxy-, monosodium salt

BUTYRIC ACID, 4-HYDROXY-, SODIUM SALT

C00989

C01991

C4H8O3

CHEBI:30830

CHEMBL1342

CTK4G5262

D0EP8X

DEA No. 2010

DTXSID2074740

EB 27

Gam-OH

Gamma Hydroxybutyric Acid

Gamma OH

gamma-hydroxy butyrate

gamma-Hydroxy sodium butyrate

gamma-Hydroxybutanoic acid

gamma-Hydroxybutyrate

gamma-Hydroxybutyrate sodium

gamma-Hydroxybutyric acid

gamma-Hydroxybutyric acid decomposition product

Gamma-Hydroxybutyric acid monosodium salt

Gamma-OH

GHB

GTPL4711

HSDB 6927

Hydroxyb

Hydroxybutyric acid monosodium salt

Hydroxybutyric acid-

HYDROXYBUTYRICACID

Juice

Liquid Ecstasy

LMFA01050006

LP090865

LS-46312

NCGC00247714-01

NSC84223

oxy-n-butyric acid

Oxybate

Oxybate sodium

PDSP1_000342

PDSP2_000340

SBI-0206686.P002

SCHEMBL10786

SHB

SJZRECIVHVDYJC-UHFFFAOYSA-N

Sodium .gamma.-hydroxybutyrate

Sodium .gamma.-oxybutyrate

Sodium gamma-oxybutyrate

Sodium Oxybate (4-hydroxybutanoic acid)

Somsanit

UNII-30IW36W5B2

utyric acid monosodium salt

WY 3478

WY-3478

Xyrem (TN)

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
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

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Paragraph IV (Patent) Challenges for XYREM

Drugname	Dosage	Strength	RLD	Date
	Oral Solution	500 mg/mL

Non-Orange Book US Patents for XYREM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,797,171	Sensitive drug distribution system and method
6,472,431	Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
8,952,029	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
8,461,203	Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy

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International Patents for XYREM

Country	Document Number	Estimated Expiration
Hong Kong	1215539
Denmark	1140061
Israel	143733
Singapore	11201505029Q

Supplementary Protection Certificates for XYREM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
14/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
14/032	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