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Last Updated: April 28, 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

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
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
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
>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

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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;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

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Country	Patent Number	Title	Estimated Expiration
South Korea	101268559		⤷ Try a Trial
Japan	2007512336		⤷ Try a Trial
Australia	2004292428	Colonic purgative composition with soluble binding agent	⤷ Try a Trial
Japan	2011173933	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT	⤷ Try a Trial
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
>Country	>Patent Number	>Title	>Estimated Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0473687	SPC/GB98/030	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
1856135	2090014-8	Sweden	⤷ Try a Trial	PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
2203431	CA 2015 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
1948158	93075	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL ET 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-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
>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.