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Last Updated: November 2, 2024

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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, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, Square Pharms, Suven Pharms, Fresenius Medcl, Chartwell Molecular, Padagis Us, and Cypress Pharm, and is included in eighteen NDAs. There are three 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 sixteen countries.

There are six drug master file entries for calcium acetate. Twenty-two suppliers are listed for this compound.

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Recent Clinical Trials for CALCIUM ACETATE

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

SponsorPhase
Peking University People's HospitalPhase 2
Mark FoxPhase 4
University of Colorado, DenverPhase 2

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Pharmacology for CALCIUM ACETATE
Paragraph IV (Patent) Challenges for CALCIUM ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PHOSLYRA Oral Solution calcium acetate 667 mg/5 mL 022581 2 2013-12-05
PHOSLO GELCAPS Capsules calcium acetate EQ 169 mg calcium 021160 1 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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Square Pharms CALCIUM ACETATE calcium acetate CAPSULE;ORAL 217205-001 Mar 13, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001 ⤷  Sign Up ⤷  Sign Up
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-001 Apr 2, 2001 ⤷  Sign Up ⤷  Sign Up
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CALCIUM ACETATE

Country Patent Number Title Estimated Expiration
European Patent Office 2484352 Compositions liquides d'acétate de calcium (Liquid compositions of calcium acetate) ⤷  Sign Up
Spain 2382993 ⤷  Sign Up
Mexico 2009000722 COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALCIUM ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2365988 2018C/006 Belgium ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 CA 2018 00043 Denmark ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2957286 132019000000021 Italy ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.