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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022127

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NDA 022127 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 022127

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022127

Mechanism of ActionPhosphate 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 KAISER FOUNDATION HOSPITALS 0179-0043 0179-0043-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0043-70)
RENVELA sevelamer carbonate TABLET;ORAL 022127 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1050 0955-1050-27 270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Oct 19, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 25, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Oct 27, 2025Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022127

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Express Scripts
Healthtrust
Chinese Patent Office
Farmers Insurance
UBS
Baxter
Fuji
Daiichi Sankyo

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