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Generated: December 13, 2017

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 is included in two NDAs. It is available from seven 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. Seventeen suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for 022318

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Genitourinary Agents
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 Genzyme Corporation 58468-0131 58468-0131-5 15 PACKET in 1 CARTON (58468-0131-5) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3)
RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318 NDA Genzyme Corporation 58468-0131 58468-0131-2 90 PACKET in 1 CARTON (58468-0131-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)

Summary 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:► SubscribePatent Expiration:Dec 6, 2030Product Flag?YSubstance Flag?Delist Request?

Summary 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 Orange Book Patents for NDA: 022318

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
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