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POTASSIUM PHOSPHATES Drug Profile

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

Potassium Phosphates is a drug marketed by Cmp Dev Llc and Fresenius Kabi Usa and is included in two 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. Two 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 19, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for POTASSIUM PHOSPHATES

International Patents:	1
US Patents:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for POTASSIUM PHOSPHATES

NDA:

212121

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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	Potassium Salt Osmotic Laxative
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

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

International Patents for POTASSIUM PHOSPHATES

Country	Patent Number	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
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
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	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
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
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;