Details for New Drug Application (NDA): 204734

✉ Email this page to a colleague

NDA 204734 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. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for 204734

Tradename:	FOSRENOL
Applicant:	Takeda Pharms Usa
Ingredient:	lanthanum carbonate
Patents:	3

Pharmacology for NDA: 204734

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 204734

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734	NDA	Takeda Pharmaceuticals America, Inc.	54092-256	54092-256-02	9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01)
FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734	NDA	Takeda Pharmaceuticals America, Inc.	54092-257	54092-257-02	9 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 750MG BASE
Approval Date:	Sep 24, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 26, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204734

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.