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Generated: December 15, 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 sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novel Labs IncMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATEsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTABLET;ORAL079247-001Dec 30, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsOSMOPREPsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTABLET;ORAL021892-001Mar 16, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► 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 PharmsOSMOPREPsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTABLET;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
Brazil122014001142► Subscribe
Spain2584866► Subscribe
Australia2015221520► Subscribe
Japan2011173933► Subscribe
South Korea20130048790► Subscribe
BrazilPI0416702► Subscribe
China101087593► Subscribe
China102648980► Subscribe
South Korea101495690► Subscribe
Argentina046651► 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
C0013France► SubscribePRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
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/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
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
Cipla
Dow
Merck
Farmers Insurance
Chubb
Deloitte
Daiichi Sankyo
Johnson and Johnson

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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