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Last Updated: November 21, 2019

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Details for New Drug Application (NDA): 021468

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NDA 021468 describes FOSRENOL, which is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSRENOL profile page.

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.
Summary for 021468
Tradename:FOSRENOL
Applicant:Shire Llc
Ingredient:lanthanum carbonate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021468
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 021468
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468 NDA Shire US Manufacturing Inc. 54092-252 54092-252-90 2 BOTTLE in 1 PACKAGE (54092-252-90) > 45 TABLET, CHEWABLE in 1 BOTTLE (54092-252-45)
FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468 NDA Shire US Manufacturing Inc. 54092-253 54092-253-90 6 BOTTLE in 1 PACKAGE (54092-253-90) > 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)
Paragraph IV (Patent) Challenges for 021468
Tradename Dosage Ingredient NDA Submissiondate
FOSRENOL TABLET, CHEWABLE;ORAL lanthanum carbonate 021468 2008-10-27

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrengthEQ 250MG BASE
Approval Date:Oct 26, 2004TE:RLD:No
Patent:  Start TrialPatent Expiration:Aug 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Patent:  Start TrialPatent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 500MG BASE
Approval Date:Oct 26, 2004TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE

Expired US Patents for NDA 021468

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 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

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