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Last Updated: August 4, 2020

DrugPatentWatch Database Preview

CALCIUM ACETATE - Generic Drug Details

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What are the generic drug sources for calcium acetate and what is the scope of freedom to operate?

Calcium acetate is the generic ingredient in five branded drugs marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, Suven Pharms, Fresenius Medcl, Chartwell Molecular, Paddock Llc, and Cypress Pharm, and is included in seventeen NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Calcium acetate has twenty-four patent family members in seventeen countries.

There are two hundred and eighty-two drug master file entries for calcium acetate. Twenty-eight suppliers are listed for this compound.

Drug Prices for CALCIUM ACETATE

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Drug Sales Revenue Trends for CALCIUM ACETATE

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Recent Clinical Trials for CALCIUM ACETATE

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SponsorPhase
Akebia TherapeuticsPhase 1
Dow University of Health SciencesPhase 3
Sultan Qaboos UniversityPhase 1/Phase 2

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Pharmacology for CALCIUM ACETATE
Paragraph IV (Patent) Challenges for CALCIUM ACETATE
Tradename Dosage Ingredient NDA Submissiondate
PHOSLYRA SOLUTION;ORAL calcium acetate 022581 2013-12-05
PHOSLO CAPSULE;ORAL calcium acetate 021160 2005-05-31
PHOSLO GELCAPS CAPSULE;ORAL calcium acetate 021160 2005-05-31

US Patents and Regulatory Information for CALCIUM ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lotus Pharm Co Ltd CALCIUM ACETATE calcium acetate CAPSULE;ORAL 203298-001 Jul 26, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Medcl PHOSLO calcium acetate TABLET;ORAL 019976-001 Dec 10, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Invagen Pharms CALCIUM ACETATE calcium acetate CAPSULE;ORAL 203135-001 Feb 7, 2013 AB RX No No   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

Expired US Patents for CALCIUM ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-001 Apr 2, 2001   Start Trial   Start Trial
Fresenius Medcl PHOSLO GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001   Start Trial   Start Trial
Fresenius Medcl PHOSLO calcium acetate TABLET;ORAL 019976-001 Dec 10, 1990   Start Trial   Start Trial
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CALCIUM ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 300962 Netherlands   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
0521471 SPC/GB03/033 United Kingdom   Start Trial PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
2957286 1990003-4 Sweden   Start Trial PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
0933372 SPC/GB08/018 United Kingdom   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Johnson and Johnson
Colorcon
Express Scripts
McKesson

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