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Last Updated: October 23, 2020

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PHOSLO GELCAPS Drug Profile

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Which patents cover Phoslo Gelcaps, and what generic alternatives are available?

Phoslo Gelcaps is a drug marketed by Fresenius Medcl and is included in one NDA. There are two patents protecting this drug.

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

US ANDA Litigation and Generic Entry Outlook for Phoslo Gelcaps

A generic version of PHOSLO GELCAPS was approved as calcium acetate by HIKMA on February 26th, 2008.

  Start Trial

Drug patent expirations by year for PHOSLO GELCAPS
Recent Clinical Trials for PHOSLO GELCAPS

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SponsorPhase
Fresenius Medical Care North AmericaPhase 1

See all PHOSLO GELCAPS clinical trials

Pharmacology for PHOSLO GELCAPS
Paragraph IV (Patent) Challenges for PHOSLO GELCAPS
Tradename Dosage Ingredient NDA Submissiondate
PHOSLO CAPSULE;ORAL calcium acetate 021160 2005-05-31
PHOSLO GELCAPS CAPSULE;ORAL calcium acetate 021160 2005-05-31

US Patents and Regulatory Information for PHOSLO GELCAPS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Medcl PHOSLO GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Medcl PHOSLO GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PHOSLO GELCAPS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 13/2008 Austria   Start Trial 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
2957286 122018000145 Germany   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2365988 CA 2018 00006 Denmark   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2957286 C02957286/01 Switzerland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
2957286 LUC00094 Luxembourg   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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