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Last Updated: October 20, 2019

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FOSRENOL Drug Profile

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When do Fosrenol patents expire, and when can generic versions of Fosrenol launch?

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 eighty-six 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.

Drug patent expirations by year for FOSRENOL
Drug Prices for FOSRENOL

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Recent Clinical Trials for FOSRENOL

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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
Synonyms for FOSRENOL
0M78EU4V9H
14475-16-2
587-26-8
AC1L52T0
ACMC-1BB7U
C3La2O9
Carbonic acid, lanthanum(3+) salt (3:2)
Carbonic acid,lanthanum(3+) salt (3:2)
Carbonic acid,lanthanum(3+) salt (3:2), hydrate (9CI)
CTK5A8757
DB06792
Dilanthanum tricarbonate
EC 209-599-5
EINECS 209-599-5
Foznol
HSDB 7758
Lanthanum (III) carbonate
Lanthanum Carbonate
lanthanum carbonate (2:3)
Lanthanum carbonate anhydrous
Lanthanum sesquicarbonate
Lanthanum(3 ) carbonate
Lanthanum(3+) carbonate
lanthanum(3+) tricarbonate
lanthanum(iii) carbonate
LS-186384
NZPIUJUFIFZSPW-UHFFFAOYSA-H
Phosbloc
TC-166469
UNII-0M78EU4V9H

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
>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 021468-003 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 Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-001 Oct 26, 2004   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 021468-004 Nov 23, 2005   Start Trial   Start Trial
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-002 Oct 26, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for FOSRENOL
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Powder 750 mg and 1000 mg ➤ Subscribe   Start Trial
➤ Subscribe Chewable Tablet 500 mg, 750 mg and 1000 mg ➤ Subscribe   Start Trial

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