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Last Updated: June 12, 2021

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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

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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
Drug patent expirations by year for POTASSIUM PHOSPHATES
DrugPatentWatch® Estimated Generic Entry Opportunity Date for POTASSIUM PHOSPHATES
Generic Entry Date for POTASSIUM PHOSPHATES*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Mahidol UniversityN/A

See all POTASSIUM PHOSPHATES clinical trials

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

Supplementary Protection Certificates for POTASSIUM PHOSPHATES

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 08C0026 France   Get Started Free PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1718641 SPC/GB12/028 United Kingdom   Get Started Free 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   Get Started Free 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   Get Started Free 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   Get Started Free 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   Get Started Free PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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