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Generated: October 18, 2017

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Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate - Generic Drug Details

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What are the generic drug sources for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate and what is the scope of sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate freedom to operate?

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
is the generic ingredient in two branded drugs marketed by Novel Labs Inc and Salix Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate has twenty-nine patent family members in eleven countries and twenty-nine supplementary protection certificates in seven countries.

There are one thousand four hundred drug master file entries for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. Three suppliers are listed for this compound.

Summary for Generic Name: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list1400
Suppliers / Packagers: see list3
Clinical Trials: see list3,177
Drug Prices:see low prices
DailyMed Link:sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate at DailyMed

Pharmacology for Ingredient: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novel Labs Inc
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL079247-001Dec 30, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

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
7,718,197Colonic purgative composition with soluble binding agent► Subscribe
8,507,009Colonic purgative composition with soluble binding agent► 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 phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Country Document Number Estimated Expiration
Poland1682098► Subscribe
Australia2012216409► Subscribe
South Korea101323628► Subscribe
Canada2814523► Subscribe
South Korea20130048790► Subscribe
China101087593► Subscribe
Japan2007512336► Subscribe
Australia2004292428► Subscribe
China102648980► Subscribe
BrazilPI0416702► 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 PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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/GB98/040United Kingdom► SubscribePRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
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
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
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
C/GB02/042United Kingdom► SubscribePRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
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Serving leading biopharmaceutical companies globally:

Julphar
US Army
Queensland Health
Cipla
Farmers Insurance
UBS
Dow
Cantor Fitzgerald
Fish and Richardson
US Department of Justice

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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