Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

DrugPatentWatch Database Preview

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.

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

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   See Pricing   See Pricing   See Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for XYREM
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 500 mg/mL ➤ Subscribe   See Pricing

Supplementary Protection Certificates for XYREM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0268956 1999C0030 Belgium   See Pricing PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2822954 18C1035 France   See Pricing 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   See Pricing PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1499331 13C0055 France   See Pricing PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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