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
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-001	Oct 10, 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
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-001	Oct 2, 2023	AP	RX	No	No
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-003	Nov 26, 2019	AP	RX	Yes	Yes

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
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
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
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;