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Serving leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Johnson and Johnson
Argus Health
Merck
Accenture
McKesson
Novartis
Cipla
US Army

Generated: January 19, 2018

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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in sixteen countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand four hundred and fifteen 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 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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 AA RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 Submissiondate
➤ Subscribe Oral Solution 500 mg/mL ➤ Subscribe 7/8/2010

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 ➤ Subscribe
6,472,431 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy ➤ Subscribe
8,461,203 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy ➤ Subscribe
8,952,029 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for XYREM

Supplementary Protection Certificates for XYREM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90018-6 Sweden ➤ Subscribe PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
14/032 Ireland ➤ Subscribe PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
C0013 France ➤ Subscribe PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
C0005 Belgium ➤ Subscribe PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C/GB08/036 United Kingdom ➤ Subscribe PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C/GB97/078 United Kingdom ➤ Subscribe PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
C/GB06/021 United Kingdom ➤ Subscribe PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
C/GB02/042 United Kingdom ➤ Subscribe PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
14/058 Ireland ➤ Subscribe PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C0018 France ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Express Scripts
QuintilesIMS
Chubb
Cantor Fitzgerald
Colorcon
Dow
Mallinckrodt
US Army

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