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Last Updated: March 19, 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

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

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
Russian Federation 2463060 ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ (LIQUID PHARMACEUTICAL COMPOSITION (VERSIONS) AND METHOD FOR PHOSPHOR BINDING IN GASTROINTESTINAL TRACT) ⤷  Try a Trial
China 104095838 Liquid compositions of calcium acetate ⤷  Try a Trial
South Korea 101553719 ⤷  Try a Trial
China 101522021 Liquid compositions of calcium acetate ⤷  Try a Trial
European Patent Office 2048948 COMPOSITIONS LIQUIDES D'ACÉTATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE) ⤷  Try a Trial
Poland 2048948 ⤷  Try a Trial
Australia 2007275606 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
0720599 122014000088 Germany ⤷  Try a 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
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 1990003-4 Sweden ⤷  Try a Trial PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
0933372 13/2008 Austria ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
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
2957286 CR 2018 00043 Denmark ⤷  Try a Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0720599 CR 2014 00050 Denmark ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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