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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Cantor Fitzgerald
Healthtrust
Teva
Fish and Richardson
McKesson
Harvard Business School
Federal Trade Commission
Dow

Generated: February 19, 2019

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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 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
Medical Subject Heading (MeSH) Categories for XYREM
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for XYREM
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 500 mg/mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for XYREM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00014 Denmark ➤ Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C/GB98/040 United Kingdom ➤ Sign Up 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
C0022 France ➤ Sign Up PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
99C0030 Belgium ➤ Sign Up PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
15/009 Ireland ➤ Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
QuintilesIMS
Merck
Fuji
Chubb
Daiichi Sankyo
Julphar
Fish and Richardson
McKinsey

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