PHOSLYRA Drug Patent Profile

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.

Summary for PHOSLYRA

International Patents:	23
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	2
Patent Applications:	1,706
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

See drug prices for PHOSLYRA

See drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for PHOSLYRA

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No
Fresenius Medcl	PHOSLYRA	calcium acetate	SOLUTION;ORAL	022581-001	Apr 18, 2011		DISCN	Yes	No			Y

International Patents for PHOSLYRA

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

Country	Patent Number	Title	Estimated Expiration
Japan	5335674
Canada	2658465	COMPOSITIONS LIQUIDES D'ACETATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)
Spain	2382993
Russian Federation	2009104774	ЖИДКАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ СВЯЗЫВАНИЯ ФОСФОРА В ЖЕЛУДОЧНО-КИШЕЧНОМ ТРАКТЕ
South Korea	20090040340	LIQUID COMPOSITIONS OF CALCIUM ACETATE

Supplementary Protection Certificates for PHOSLYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
2957286	CA 2018 00043	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0521471	C300125	Netherlands		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