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Last Updated: March 29, 2024

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 three branded drugs marketed by Novel Labs Inc and Salix Pharms, and is included in three 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.

Summary for sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
International Patents:29
US Patents:1
Tradenames:3
Applicants:2
NDAs:3
DailyMed Link:sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate at DailyMed
Pharmacology 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 Strength NDA ANDAs Submitted Submissiondate
OSMOPREP Tablets sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate 1.102 g and 0.398 g 021892 1 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
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 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Salix Pharms VISICOL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021097-001 Sep 21, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 a Trial ⤷  Try a Trial
Salix Pharms VISICOL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021097-001 Sep 21, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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 Title Estimated Expiration
Brazil PI0416702 FORMULAÇÃO PURGATIVA COLÔNICA, KIT, MÉTODOS DE PURGAR O CÓLON DE UM PACIENTE, DE TRATAR UM PACIENTE COM, OU SUSCETÍVEL A, UM DISTÚRBIO GASTROINTESTINAL, E DE TRATAR UM PACIENTE SOFRENDO DE, OU SUSCETÍVEL À, CONSTIPAÇÃO, E, PROCESSO DE PRODUZIR A FORMULAÇÃO PURGATIVA COLÔNICA ⤷  Try a Trial
Japan 2014065746 COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT ⤷  Try a Trial
Brazil 122014001142 Formulação purgativa colônica, kit, método de purgar o cólon de um paciente, e, processo de produzir a formulação purgativa colônica ⤷  Try a Trial
South Korea 20110098015 COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT ⤷  Try a Trial
Australia 2015221520 COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT ⤷  Try a Trial
>Country >Patent Number >Title >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
0579826 SPC/GB02/042 United Kingdom ⤷  Try a Trial PRODUCT 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 20020422
1499331 SPC/GB13/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0480717 98C0022 France ⤷  Try a Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1948158 16C0018 France ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1912999 1490062-5 Sweden ⤷  Try a Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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 verification 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.