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Last Updated: April 23, 2024

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 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

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
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	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
>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
Spain	2584866		⤷ Try a Trial
Canada	2814523	COMPOSITION PURGATIVE POUR LE COLON A AGENT DE LIAISON SOLUBLE (COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT)	⤷ Try a Trial
South Korea	101268559		⤷ Try a Trial
Japan	2014065746	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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	2015/009	Ireland	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1259550	08C0052	France	⤷ Try a Trial	PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
0186405	SPC/GB00/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1758590	2017C/063	Belgium	⤷ Try a Trial	PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
>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.