Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

XYREM Drug Profile

« Back to Dashboard

Which patents cover Xyrem, and what substitute generic drugs 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-six patent family members in sixteen countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand three hundred and sixty 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 Tradename: XYREM

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list15
Clinical Trials: see list14
Patent Applications: see list5,243
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XYREM at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYesYes7,668,730► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYesYes9,486,426► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYesYes8,263,650► SubscribeY ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYesYes7,851,506► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYesYes8,589,182► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: XYREM

Drugname Dosage Strength RLD Submissiondate
sodium oxybateOral Solution500 mg/mLXyrem7/8/2010

Non-Orange Book Patents for Tradename: 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
6,472,431 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► Subscribe
7,797,171Sensitive drug distribution system and method► Subscribe
8,952,029Method of administration of gamma hydroxybutyrate with monocarboxylate transporters► Subscribe
8,461,203Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: XYREM

Country Document Number Estimated Expiration
European Patent Office2961399► Subscribe
China105073106► Subscribe
Australia2059000► Subscribe
World Intellectual Property Organization (WIPO)0038672► Subscribe
Israel240874► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: XYREM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0108Belgium► SubscribePRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
C/GB08/036United Kingdom► SubscribePRODUCT 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/GB00/021United Kingdom► SubscribePRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc