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Sodium oxybate - Generic Drug Details

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Sodium oxybate is the generic ingredient in two branded drugs marketed by West-ward Pharms Int and Jazz Pharms, and is included in two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-six patent family members in sixteen countries.

There are one thousand three hundred and sixty drug master file entries for sodium oxybate. One supplier is listed for this compound.

Summary for Generic Name: sodium oxybate

Tradenames:2
Patents:18
Applicants:2
NDAs:2
Drug Master File Entries: see list1360
Suppliers / Packagers: see list1
Bulk Api Vendors: see list49
Clinical Trials: see list922
Patent Applications: see list5,248
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sodium oxybate 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, 2002RXYesYes7,765,107► 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, 2002RXYesYes8,457,988► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: sodium oxybate

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
8,461,203Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► subscribe
8,952,029Method of administration of gamma hydroxybutyrate with monocarboxylate transporters► subscribe
7,797,171Sensitive drug distribution system and method► 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 Ingredient: sodium oxybate

Country Document Number Estimated Expiration
Canada2355293► subscribe
World Intellectual Property Organization (WIPO)0038672► subscribe
Spain2193777► 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: SODIUM OXYBATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005Belgium► subscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
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
C0022France► subscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
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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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