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Generated: December 14, 2018

DrugPatentWatch Database Preview

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 five 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 eight 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:3
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)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrengthEQ 250MG BASE
Approval Date:Oct 26, 2004TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Oct 26, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE
Patent:➤ Sign UpPatent Expiration:Aug 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Patent:➤ Sign UpPatent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?

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 021468-002 Oct 26, 2004 ➤ Sign Up ➤ Sign Up
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 ➤ Sign Up ➤ Sign Up
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-001 Oct 26, 2004 ➤ Sign Up ➤ Sign Up
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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