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Last Updated: July 10, 2020

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PHOSLYRA Drug 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-four patent family members in seventeen countries.

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

US ANDA 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

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Pharmacology for PHOSLYRA
Paragraph IV (Patent) Challenges for PHOSLYRA
Tradename Dosage Ingredient NDA Submissiondate
PHOSLYRA SOLUTION;ORAL calcium acetate 022581 2013-12-05

US Patents and Regulatory Information for PHOSLYRA

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

Supplementary Protection Certificates for PHOSLYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2365988 LUC00061 Luxembourg   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Merck
Colorcon
McKinsey
Johnson and Johnson

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