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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Cantor Fitzgerald
Farmers Insurance
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Queensland Health
Chubb
Cerilliant
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Generated: November 23, 2017

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PHOSLYRA Drug Profile

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Which patents cover Phoslyra, and when can generic versions of Phoslyra launch?

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 seventeen countries and eight supplementary protection certificates in five countries.

The generic ingredient in PHOSLYRA is calcium acetate. There are two hundred and seventy drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
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;ORAL022581-001Apr 18, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Medcl
PHOSLYRA
calcium acetate
SOLUTION;ORAL022581-001Apr 18, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Fresenius Medcl
PHOSLYRA
calcium acetate
SOLUTION;ORAL022581-001Apr 18, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for PHOSLYRA

Drugname Dosage Strength RLD Submissiondate
calcium acetateOral Solution667 mg/5 mLPhoslyra12/5/2013

International Patent Family for Tradename: PHOSLYRA

Country Document Number Estimated Expiration
European Patent Office2048948► Subscribe
World Intellectual Property Organization (WIPO)2008011126► Subscribe
Russian Federation2463060► Subscribe
Russian Federation2009104774► Subscribe
Hong Kong1129814► Subscribe
Hong Kong1202815► Subscribe
Spain2382993► Subscribe
South Korea20090040340► Subscribe
Canada2658465► Subscribe
Australia2007275606► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PHOSLYRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
C/GB03/033United Kingdom► SubscribePRODUCT 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
2014 00050Denmark► SubscribePRODUCT 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
2008006Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
/1997Austria► SubscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
00125Netherlands► SubscribePRODUCT 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
/2008Austria► SubscribePRODUCT 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/GB08/018United Kingdom► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Cipla
Deloitte
Argus Health
Johnson and Johnson
Baxter
Accenture
Healthtrust
Express Scripts
Merck
Fish and Richardson

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 verifification 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.

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