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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Deloitte
US Army
Baxter
QuintilesIMS
AstraZeneca
Teva
Merck
Mallinckrodt

Generated: October 23, 2018

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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.

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

Drug patent expirations by year for PHOSLYRA
Pharmacology for PHOSLYRA
Synonyms for PHOSLYRA
62-54-4
AC1L1LU9
AC1LANU5
Acetate of lime
acetic acid calcium salt
Acetic acid, calcium salt
Acetic acid, calcium salt (2:1)
AI3-02903
AKOS015904560
AN-23726
API0024654
Brown acetate
Brown Acetate of Lime
Ca(OAc)2
Calac
Calcium acetate
Calcium Acetate (Fragrance Grade)
Calcium acetate (USP)
Calcium acetate [USAN:JAN]
Calcium acetate [USP:JAN]
Calcium Acetate 23% 10M
Calcium acetate hydrate, Puratronic
calcium acetate salt
Calcium Acetate, FCC
CALCIUM ACETATEULTRA PURE
Calcium di(acetate)
Calcium diacetate
calcium diacetate, CAc - acetic acid, calcium salt
calcium ethanoate
calcium(2+) bis(acetate ion)
calcium(II) acetate
CCRIS 4921
CHEBI:3310
CHEMBL1200800
D00931
D0F1GS
DB00258
DTXSID0020234
E263
EC 200-540-9
EINECS 200-540-9
Eliphos
FEMA No. 2228
FT-0623376
GE2473
Gray acetate
Gray Acetate of Lime
Grey acetate
HSDB 928
I14-16503
IN017428
J-519530
Lime acetate
Lime pyrolignite
LS-2337
Niacet calcium acetate tech
OR033975
OR205936
PhosLo
Phoslo (TN)
Phoslo Gelcaps
Procalamine
Pyrolignite of lime
RP22176
Sanopan
SC-18378
SCHEMBL23872
Sorbo-calcian
Sorbo-calcion
Teltozan
UNII-Y882YXF34X
Vinegar salts
VSGNNIFQASZAOI-UHFFFAOYSA-L
Y882YXF34X

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

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Paragraph IV (Patent) Challenges for PHOSLYRA
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 667 mg/5 mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PHOSLYRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00125 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
2008006 Lithuania ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0689 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
/2008 Austria ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
C/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
2008006,C0933372 Lithuania ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Deloitte
US Army
Baxter
QuintilesIMS
AstraZeneca
Teva
Merck
Mallinckrodt

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