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
Hong Kong	1202815	醋酸鈣的液體組合物 (LIQUID COMPOSITIONS OF CALCIUM ACETATE)
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
Japan	2009544615
Austria	E547099
China	104095838	Liquid compositions of calcium acetate
Poland	2048948
Canada	2658465	COMPOSITIONS LIQUIDES D'ACETATE DE CALCIUM (LIQUID COMPOSITIONS OF CALCIUM ACETATE)

Supplementary Protection Certificates for PHOSLYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0933372	SPC/GB08/018	United Kingdom		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		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719