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XYREM Drug Profile

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Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries.

The generic ingredient in XYREM is sodium oxybate. There are one thousand three hundred and fifty 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:16
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYes7,668,730► subscribe ► subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYes6,780,889► subscribeY ► subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002RXYes8,263,650► subscribeY ► subscribe
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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
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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.

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International Patent Family for Tradename: XYREM

Country Document Number Estimated Expiration
Taiwan201511752► subscribe
European Patent Office2961399► subscribe
Japan4374441► subscribe
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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.

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Supplementary Protection Certificates for Tradename: XYREM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0052France► subscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C0055France► subscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
14/032Ireland► subscribePRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
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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.

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