Details for New Drug Application (NDA): 022127

✉ Email this page to a colleague

NDA 022127 describes RENVELA, which is a drug marketed by Genzyme and Sanofi and is included in two NDAs. It is available from two 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 022127

Tradename:	RENVELA
Applicant:	Sanofi
Ingredient:	sevelamer carbonate
Patents:	1

Pharmacology for NDA: 022127

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 022127

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RENVELA	sevelamer carbonate	TABLET;ORAL	022127	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1050	0955-1050-27	270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27)
RENVELA	sevelamer carbonate	TABLET;ORAL	022127	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1057	0955-1057-30	270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 19, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 27, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022127

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	⤷ Sign Up	⤷ Sign Up
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	⤷ Sign Up	⤷ Sign Up
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	⤷ Sign Up	⤷ Sign Up
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	⤷ 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.