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Last Updated: September 23, 2020

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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.

US ANDA Litigation and 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
Suppliers / Packagers: 2
Clinical Trials: 1
Formulation / Manufacturing:see details
DailyMed Link:POTASSIUM PHOSPHATES at DailyMed
Drug patent expirations by year for POTASSIUM PHOSPHATES
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   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa POTASSIUM PHOSPHATES potassium phosphate, dibasic; potassium phosphate, monobasic SOLUTION;INTRAVENOUS 212832-003 Nov 26, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa POTASSIUM PHOSPHATES potassium phosphate, dibasic; potassium phosphate, monobasic SOLUTION;INTRAVENOUS 212832-001 Nov 26, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa POTASSIUM PHOSPHATES potassium phosphate, dibasic; potassium phosphate, monobasic SOLUTION;INTRAVENOUS 212832-002 Nov 26, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 2008/010 Ireland   Start Trial PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1718641 2012/008 Ireland   Start Trial 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
0733366 SPC/GB98/031 United Kingdom   Start Trial 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
1441735 SPC/GB08/020 United Kingdom   Start Trial PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1441735 08C0026 France   Start Trial PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
0480717 98C0025 Belgium   Start Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.