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Last Updated: October 21, 2021

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

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What are the generic sources for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate and what is the scope of 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.

There are one thousand four hundred and seventy-two drug master file entries for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. One supplier is listed for this compound.

Summary for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Paragraph IV (Patent) Challenges for SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Tradename Dosage Ingredient NDA Submissiondate
OSMOPREP TABLET;ORAL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate 021892 2008-04-09

US Patents and Regulatory Information 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 Product Substance Delist Req. Exclusivity Expiration
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Novel Labs Inc MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 079247-001 Dec 30, 2011 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for 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;ORAL 021892-001 Mar 16, 2006 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Country Patent Number Estimated Expiration
Australia 2004292428 ⤷  Try it Free
South Korea 20060114342 ⤷  Try it Free
South Korea 101323628 ⤷  Try it Free
Australia 2012202628 ⤷  Try it Free
Spain 2584866 ⤷  Try it Free
Japan 2011173933 ⤷  Try it Free
China 102648980 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713823 1490064-1 Sweden ⤷  Try it Free PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1874117 SPC/GB14/041 United Kingdom ⤷  Try it Free PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
0788511 SPC/GB08/036 United Kingdom ⤷  Try it Free PRODUCT 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
2203431 CR 2015 00014 Denmark ⤷  Try it Free PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1499331 13C0055 France ⤷  Try it Free PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
2673237 LUC00111 Luxembourg ⤷  Try it Free PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
2563920 CA 2019 00001 Denmark ⤷  Try it Free PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Merck
Colorcon
Baxter
McKesson

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