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Last Updated: March 29, 2024

PHOSLYRA Drug Patent Profile


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When do Phoslyra patents expire, and what generic alternatives are available?

Phoslyra is a drug marketed by Fresenius Medcl and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in sixteen countries.

The generic ingredient in PHOSLYRA is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Phoslyra

A generic version of PHOSLYRA was approved as calcium acetate by HIKMA on February 26th, 2008.

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Drug patent expirations by year for PHOSLYRA
Drug Prices for PHOSLYRA

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Drug Sales Revenue Trends for PHOSLYRA

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Recent Clinical Trials for PHOSLYRA

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SponsorPhase
Vifor Fresenius Medical Care Renal PharmaPhase 3
Fresenius Medical Care North AmericaPhase 4

See all PHOSLYRA clinical trials

Paragraph IV (Patent) Challenges for PHOSLYRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PHOSLYRA Oral Solution calcium acetate 667 mg/5 mL 022581 2 2013-12-05

US Patents and Regulatory Information for PHOSLYRA

PHOSLYRA is protected by three US patents.

Patents protecting PHOSLYRA

Liquid compositions of calcium acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

Liquid compositions of calcium acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

Liquid compositions of calcium acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PHOSLYRA

See the table below for patents covering PHOSLYRA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2484352 Compositions liquides d'acétate de calcium (Liquid compositions of calcium acetate) ⤷  Try a Trial
Japan 2009544615 ⤷  Try a Trial
Russian Federation 2009104774 ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ ⤷  Try a Trial
European Patent Office 2048948 COMPOSITIONS LIQUIDES D'ACÉTATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE) ⤷  Try a Trial
New Zealand 574331 LIQUID COMPOSITIONS OF CALCIUM ACETATE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PHOSLYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2365988 2018C/006 Belgium ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 2018C/047 Belgium ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0720599 300689 Netherlands ⤷  Try a 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
2365988 CA 2018 00006 Denmark ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2957286 6/2019 Austria ⤷  Try a Trial PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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