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

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

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
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006		DISCN	Yes	No			Y	Y
Salix Pharms	VISICOL	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021097-001	Sep 21, 2000		DISCN	No	No

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
Salix Pharms	VISICOL	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021097-001	Sep 21, 2000

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012216409	Colonic purgative composition with soluble binding agent
South Korea	20060114342	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT
South Korea	20120045015	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT
Japan	5329042
Argentina	046651	COMPOSICION PURGANTE COLONICA CON AGENTE AGLUTINANTE SOLUBLE
Australia	2015221520	COLONIC PURGATIVE COMPOSITION WITH SOLUBLE BINDING AGENT
Australia	2012202628	Colonic purgative composition with soluble binding agent

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
2673237	LUC00111	Luxembourg		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
2380576	20C1048	France		PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
2203431	CR 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016