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

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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.

This ingredient has twenty-seven patent family members in nine countries.

There are one thousand three hundred and nine drug master file entries for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. Two suppliers are listed for this compound.

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

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list1309
Suppliers / Packaging: see list3

Clinical Trials for: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD 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, 2006RXYes7,687,075<disabled>YY <disabled>
Novel Labs Inc
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL079247-001Dec 30, 2011DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

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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, 20065,616,346<disabled>
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International Patent Family for Ingredient: sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Country Document Number Publication Date
South Korea20060114342Nov 06, 2006
China102648980Aug 29, 2012
Japan5329042Oct 30, 2013
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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