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POTASSIUM PHOSPHATES Drug Patent Profile

When do Potassium Phosphates patents expire, and when can generic versions of Potassium Phosphates launch?

Potassium Phosphates is a 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 drug.

This drug has one patent family member in one country.

The generic ingredient in POTASSIUM PHOSPHATES is potassium phosphate, dibasic; potassium phosphate, monobasic. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.

DrugPatentWatch^® Generic Entry Outlook for Potassium Phosphates

Indicators of Generic Entry

Summary for POTASSIUM PHOSPHATES

International Patents:	1
US Patents:	1
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in POTASSIUM PHOSPHATES?	POTASSIUM PHOSPHATES excipients list
DailyMed Link:	POTASSIUM PHOSPHATES at DailyMed

Recent Clinical Trials for POTASSIUM PHOSPHATES

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mahidol University	N/A

See all POTASSIUM PHOSPHATES clinical trials

Pharmacology for POTASSIUM PHOSPHATES

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 PHOSPHATES

POTASSIUM PHOSPHATES is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting POTASSIUM PHOSPHATES

FDA Regulatory Exclusivity protecting POTASSIUM PHOSPHATES

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	216274-001	Oct 2, 2023	AP	RX	No	No
Cmp Dev Llc	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212121-001	Sep 19, 2019		RX	Yes	Yes			Y
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-001	Oct 10, 2023	AP	RX	No	No

International Patents for POTASSIUM PHOSPHATES

See the table below for patents covering POTASSIUM PHOSPHATES around the world.

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

Supplementary Protection Certificates for POTASSIUM PHOSPHATES

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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;