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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

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 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-three 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 ActionPhosphate 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. 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. 0955-1054 0955-1054-90 90 PACKET in 1 BOX (0955-1054-90) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01)
Paragraph IV (Patent) Challenges for 022318
Tradename Dosage Ingredient NDA Submissiondate
RENVELA FOR SUSPENSION;ORAL sevelamer carbonate 022318 2009-12-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength800MG/PACKET
Approval Date:Aug 12, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 25, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Dec 6, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength2.4GM/PACKET
Approval Date:Feb 18, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 25, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 022318

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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