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Last Updated: June 3, 2020

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FOSRENOL Drug Profile


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Which patents cover Fosrenol, and what generic alternatives are available?

Fosrenol is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has ninety patent family members in thirty-one countries.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

US ANDA Litigation and Generic Entry Outlook for Fosrenol

A generic version of FOSRENOL was approved as lanthanum carbonate by NATCO PHARMA LTD on August 11th, 2017.

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Drug patent expirations by year for FOSRENOL
Drug Prices for FOSRENOL

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Recent Clinical Trials for FOSRENOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Universitair Ziekenhuis BrusselPhase 3
Astellas Pharma IncPhase 1
FibroGenPhase 1

See all FOSRENOL clinical trials

Recent Litigation for FOSRENOL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Shire Development LLC v. Alkem Laboratories Ltd.2016-08-24
Shire Development LLC v. Apotex, Inc.2015-11-12
SHIRE DEVELOPMENT LLC v. INVAGEN PHARMACEUTICALS, INC.2015-01-20

See all FOSRENOL litigation

Pharmacology for FOSRENOL
Paragraph IV (Patent) Challenges for FOSRENOL
Tradename Dosage Ingredient NDA Submissiondate
FOSRENOL POWDER;ORAL lanthanum carbonate 204734 2015-11-25
FOSRENOL TABLET, CHEWABLE;ORAL lanthanum carbonate 021468 2008-10-27

US Patents and Regulatory Information for FOSRENOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Dev Llc FOSRENOL lanthanum carbonate POWDER;ORAL 204734-002 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Shire Dev Llc FOSRENOL lanthanum carbonate POWDER;ORAL 204734-001 Sep 24, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-002 Oct 26, 2004 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire Dev Llc FOSRENOL lanthanum carbonate POWDER;ORAL 204734-002 Sep 24, 2014 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

Expired US Patents for FOSRENOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005   Start Trial   Start Trial
Shire Dev Llc FOSRENOL lanthanum carbonate POWDER;ORAL 204734-002 Sep 24, 2014   Start Trial   Start Trial
Shire Dev Llc FOSRENOL lanthanum carbonate POWDER;ORAL 204734-001 Sep 24, 2014   Start Trial   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-002 Oct 26, 2004   Start Trial   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005   Start Trial   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-001 Oct 26, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FOSRENOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817639 PA2008005,C0817639 Lithuania   Start Trial PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029
0817639 PA2008005 Lithuania   Start Trial PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
0817639 SPC/GB06/036 United Kingdom   Start Trial SPC/GB06/036: 20061027
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
McKinsey
McKesson
Baxter
Johnson and Johnson

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