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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021468


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NDA 021468 describes FOSRENOL, which is a drug marketed by Takeda Pharms Usa 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:Takeda Pharms Usa
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 Takeda Pharmaceuticals America, 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 Takeda Pharmaceuticals America, 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:⤷  Free Forever TrialPatent Expiration:Aug 26, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Patent:⤷  Free Forever 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:⤷  Free Forever 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
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-004 Nov 23, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-002 Oct 26, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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