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Last Updated: September 25, 2022

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-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 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

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Pharmacology for PHOSLYRA
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

Liquid compositions of calcium acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

Liquid compositions of calcium acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Medcl PHOSLYRA calcium acetate SOLUTION;ORAL 022581-001 Apr 18, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Mexico 2009000722 COMPOSICIONES LIQUIDAS DE ACETATO DE CALCIO. (LIQUID COMPOSITIONS OF CALCIUM ACETATE.) See Plans and Pricing
New Zealand 574331 LIQUID COMPOSITIONS OF CALCIUM ACETATE See Plans and Pricing
South Africa 200900472 Liquid compositions of calcium acetate See Plans and Pricing
Poland 2048948 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008011126 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PHOSLYRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 6/2019 Austria See Plans and Pricing PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
2957286 CR 2018 00043 Denmark See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2365988 CA 2018 00006 Denmark See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0933372 PA2008006,C0933372 Lithuania See Plans and Pricing PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286 SPC/GB19/003 United Kingdom See Plans and Pricing PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 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.