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Generated: September 26, 2017

DrugPatentWatch Database Preview

Sodium oxybate - Generic Drug Details

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What are the generic sources for sodium oxybate and what is the scope of sodium oxybate patent protection?

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.

Sodium oxybate has twenty-six patent family members in sixteen countries.

There are one thousand three hundred and ninety-two 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 list1392
Suppliers / Packagers: see list1
Bulk Api Vendors: see list49
Clinical Trials: see list2,389
Patent Applications: see list7,980
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► SubscribeY ► Subscribe
West-ward Pharms Int
SODIUM OXYBATE
sodium oxybate
SOLUTION;ORAL202090-001Jan 17, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► SubscribeY ► 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
6,472,431 Microbiologically 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
8,461,203Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► 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
Germany69907508► Subscribe
Australia2014223373► Subscribe
Japan4374441► Subscribe
Spain2193777► Subscribe
Austria238783► Subscribe
World Intellectual Property Organization (WIPO)0038672► Subscribe
European Patent Office1140061► Subscribe
Israel143733► Subscribe
China105073106► Subscribe
Australia779354► 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
C/GB97/078United Kingdom► SubscribePRODUCT 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
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
C/GB07/011United Kingdom► SubscribePRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
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
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Covington
US Department of Justice
Citi
Queensland Health
Chinese Patent Office
Harvard Business School
QuintilesIMS
Healthtrust

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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