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Last Updated: November 15, 2019

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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 freedom to operate?

Calcium acetate is the generic ingredient in five branded drugs marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, West-ward Pharms Int, Fresenius Medcl, Chartwell Molecular, Paddock Llc, and Cypress Pharm, and is included in sixteen 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-three patent family members in seventeen countries.

There are two hundred and eighty-two drug master file entries for calcium acetate. Twenty-nine 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
Sultan Qaboos UniversityPhase 1/Phase 2
International Centre for Diarrhoeal Disease Research, BangladeshN/A
Assiut UniversityPhase 3

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Recent Litigation for CALCIUM ACETATE

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District Court Litigation
Case NameDate
FRESENIUS MEDICAL CARE HOLDINGS, INC. v. SUVEN LIFE SCIENCES, LTD2019-05-13
ROXANE LABORATORIES, INC. v. NOVEL LABORATORIES, INC.2015-07-17
Roxane Laboratories, Inc. v. Camber Pharmaceuticals Inc.2014-09-09

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Pharmacology for CALCIUM ACETATE
Synonyms for CALCIUM ACETATE
62-54-4
AC1L1LU9
AC1LANU5
Acetate of lime
acetic acid calcium salt
Acetic acid, calcium salt
Acetic acid, calcium salt (2:1)
AI3-02903
AKOS015904560
AN-23726
API0024654
Brown acetate
Brown Acetate of Lime
Ca(OAc)2
Calac
Calcium Acetate (Fragrance Grade)
Calcium acetate (USP)
Calcium acetate [USAN:JAN]
Calcium acetate [USP:JAN]
Calcium Acetate 23% 10M
calcium acetate salt
Calcium Acetate, FCC
CALCIUM ACETATEULTRA PURE
Calcium di(acetate)
Calcium diacetate
calcium diacetate, CAc - acetic acid, calcium salt
calcium ethanoate
calcium(2+) bis(acetate ion)
calcium(II) acetate
CCRIS 4921
CHEBI:3310
CHEMBL1200800
D00931
DB00258
DTXSID0020234
E263
EC 200-540-9
EINECS 200-540-9
FEMA No. 2228
FT-0623376
GE2473
Gray acetate
Gray Acetate of Lime
Grey acetate
HSDB 928
I14-16503
J-519530
Lime acetate
Lime pyrolignite
LS-2337
Niacet calcium acetate tech
PhosLo
Phoslo (TN)
Phoslo Gelcaps
Phoslyra
Procalamine
Pyrolignite of lime
RP22176
Sanopan
SC-18378
SCHEMBL23872
Sorbo-calcian
Sorbo-calcion
Teltozan
UNII-Y882YXF34X
Vinegar salts
VSGNNIFQASZAOI-UHFFFAOYSA-L
Y882YXF34X
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
Cypress Pharm ELIPHOS calcium acetate TABLET;ORAL 078502-001 Nov 25, 2008 DISCN No 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
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
West-ward Pharms Int CALCIUM ACETATE calcium acetate TABLET;ORAL 077693-001 Jan 30, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Nostrum Labs Inc CALCIUM ACETATE calcium acetate CAPSULE;ORAL 203179-001 Oct 26, 2015 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 CAPSULE;ORAL 021160-002 Apr 2, 2001   Start Trial   Start Trial
Fresenius Medcl PHOSLO calcium acetate TABLET;ORAL 019976-001 Dec 10, 1990   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 2018C/047 Belgium   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
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 122018000145 Germany   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0720599 122014000088 Germany   Start Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
0521471 C300125 Netherlands   Start Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
>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

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