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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 022318

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NDA 022318 describes RENVELA, which is a drug marketed by Genzyme and Sanofi and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RENVELA profile page.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for 022318

Tradename:	RENVELA
Applicant:	Genzyme
Ingredient:	sevelamer carbonate
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022318

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 022318

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1052	0955-1052-90	90 PACKET in 1 BOX (0955-1052-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1052-01)
RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1054	0955-1054-90	90 PACKET in 1 BOX (0955-1054-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	800MG/PACKET
Approval Date:	Aug 12, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Dec 6, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	2.4GM/PACKET
Approval Date:	Feb 18, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Dec 6, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022318

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Genzyme	RENVELA	sevelamer carbonate	FOR SUSPENSION;ORAL	022318-002	Feb 18, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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