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Serving leading biopharmaceutical companies globally:

McKinsey
Accenture
Boehringer Ingelheim
QuintilesIMS
Moodys
Covington
Deloitte
Citi
Fuji
Cantor Fitzgerald

Generated: November 24, 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-seven patent family members in sixteen countries and twenty-nine supplementary protection certificates in seven countries.

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

Medical Subject Heading (MeSH) Categories for sodium oxybate

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► Subscribe ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► SubscribeY ► Subscribe
Jazz Pharms
XYREM
sodium oxybate
SOLUTION;ORAL021196-001Jul 17, 2002AARXYesYes► Subscribe► SubscribeY ► 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
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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
7,797,171Sensitive drug distribution system and method► Subscribe
8,952,029Method of administration of gamma hydroxybutyrate with monocarboxylate transporters► Subscribe
6,472,431 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► Subscribe
8,461,203Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy► 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
Japan2016510031► Subscribe
Mexico2015011242► Subscribe
European Patent Office1316309► Subscribe
Israel143733► Subscribe
Australia779354► Subscribe
Japan2009167189► Subscribe
South Korea20150125943► Subscribe
Spain2193777► Subscribe
Australia2014223373► Subscribe
Japan5204685► 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
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
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
C0108Belgium► SubscribePRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
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
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C0013France► SubscribePRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Argus Health
Boehringer Ingelheim
UBS
Mallinckrodt
Baxter
Chinese Patent Office
Colorcon
Cerilliant

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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