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Last Updated: August 9, 2020

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Calcium acetate - Generic Drug Details

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What are the generic drug sources for calcium acetate and what is the scope of patent protection?

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

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

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

See all calcium acetate clinical trials

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
Chartwell Rx CALCIUM ACETATE calcium acetate CAPSULE;ORAL 091312-001 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma CALCIUM ACETATE calcium acetate CAPSULE;ORAL 077728-001 Feb 26, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Cypress Pharm ELIPHOS calcium acetate TABLET;ORAL 078502-001 Nov 25, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma CALCIUM ACETATE calcium acetate TABLET;ORAL 077693-001 Jan 30, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Medcl PHOSLO GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001 DISCN No No   Start Trial   Start Trial   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
>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
0720599 CR 2014 00050 Denmark   Start Trial PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286 2018/046 Ireland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 122018000145 Germany   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2365988 122018000012 Germany   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 132019000000021 Italy   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
0720599 300689 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Baxter
McKinsey
Dow
Johnson and Johnson

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