Potassium phosphate, dibasic; potassium phosphate, monobasic - Generic Drug Details

What are the generic sources for potassium phosphate, dibasic; potassium phosphate, monobasic and what is the scope of freedom to operate?

Potassium phosphate, dibasic; potassium phosphate, monobasic is the generic ingredient in one branded drug marketed by Am Regent, Amneal, Cmp Dev Llc, and Fresenius Kabi Usa, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Potassium phosphate, dibasic; potassium phosphate, monobasic has one patent family member in one country.

Three suppliers are listed for this compound.

Summary for potassium phosphate, dibasic; potassium phosphate, monobasic

International Patents:	1
US Patents:	1
Tradenames:	1
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
DailyMed Link:	potassium phosphate, dibasic; potassium phosphate, monobasic at DailyMed

Pharmacology for potassium phosphate, dibasic; potassium phosphate, monobasic

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

US Patents and Regulatory Information for potassium phosphate, dibasic; potassium phosphate, monobasic

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-003	Oct 2, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-002	Nov 26, 2019	AP	RX	Yes	Yes
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-002	Oct 2, 2023	AP	RX	No	No
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-002	Oct 10, 2023	AP	RX	No	No
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-001	Oct 10, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-001	Nov 26, 2019	AP	RX	Yes	Yes
Cmp Dev Llc	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212121-001	Sep 19, 2019		RX	Yes	Yes			Y

International Patents for potassium phosphate, dibasic; potassium phosphate, monobasic

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020081118

Supplementary Protection Certificates for potassium phosphate, dibasic; potassium phosphate, monobasic

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1499331	SPC/GB13/034	United Kingdom		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
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
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209