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Last Updated: January 28, 2020

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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 fourteen 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.

US ANDA Litigation and Generic Entry Outlook for Xyrem

A generic version of XYREM was approved as sodium oxybate by HIKMA on January 28th, 2020.

  Start Trial

Drug patent expirations by year for XYREM
Drug Prices for XYREM

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Recent Litigation for XYREM

Identify potential future generic entrants

District Court Litigation
Case NameDate
JAZZ PHARMACEUTICALS, INC. v. MALLINCKRODT PLC2018-01-02
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
PetitionerDate
RANBAXY INC2016-03-10
Amneal Pharmaceuticals LLC2016-02-02
Ranbaxy, Inc.2015-10-07

See all XYREM litigation

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
Paragraph IV (Patent) Challenges for XYREM
Tradename Dosage Ingredient NDA Submissiondate
XYREM SOLUTION;ORAL sodium oxybate 021196 2010-07-08

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   Start Trial   Start Trial   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XYREM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0473687 SPC/GB98/030 United Kingdom   Start Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
1948158 1690020-1 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
1666481 17C1031 France   Start Trial PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1758590 LUC00029 Luxembourg   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2822954 1890030-8 Sweden   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
2822954 18C1035 France   Start Trial PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Johnson and Johnson
Moodys
Express Scripts
Colorcon

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