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 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 26^th, 2008.

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Summary for PHOSLYRA

International Patents:	23
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PHOSLYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLYRA
What excipients (inactive ingredients) are in PHOSLYRA?	PHOSLYRA excipients list
DailyMed Link:	PHOSLYRA at DailyMed

Drug patent expirations by year for PHOSLYRA

Recent Clinical Trials for PHOSLYRA

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

Sponsor	Phase
Vifor Fresenius Medical Care Renal Pharma	Phase 3
Fresenius Medical Care North America	Phase 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

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Glossary

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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				⤷ Sign Up
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2007275606	Liquid compositions of calcium acetate	⤷ Sign Up
European Patent Office	2048948	COMPOSITIONS LIQUIDES D'ACÉTATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)	⤷ Sign Up
Hong Kong	1202815	醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE)	⤷ Sign Up
Brazil	PI0714882	composiÇço lÍquida de acetato de cÁlcio e uso de uma soluÇço aquosa que compreende entre cerca de 7% (p/v) e cerca de 21% (p/v) de acetato de cÁlcio	⤷ Sign Up
Japan	2009544615		⤷ Sign Up
Poland	2048948		⤷ Sign Up
Canada	2658465	COMPOSITIONS LIQUIDES D'ACETATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PHOSLYRA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	CR 2014 00050	Denmark	⤷ Sign Up	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
0720599	300689	Netherlands	⤷ Sign Up	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	122018000145	Germany	⤷ Sign Up	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0521471	C300125	Netherlands	⤷ Sign Up	PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
0933372	SPC/GB08/018	United Kingdom	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
2957286	2018C/047	Belgium	⤷ Sign Up	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	CR 2018 00043	Denmark	⤷ Sign Up	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description