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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Federal Trade Commission
Chinese Patent Office
Healthtrust
US Army
Deloitte
Argus Health
Cantor Fitzgerald
US Department of Justice

Generated: April 20, 2018

DrugPatentWatch Database Preview

RENVELA Drug Profile

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When do Renvela patents expire, and what generic alternatives are available?

Renvela is a drug marketed by Genzyme and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-two patent family members in twenty-one countries.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for RENVELA
International Patents:52
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 6
Clinical Trials: 21
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RENVELA at DailyMed
Drug patent expirations by year for RENVELA
Pharmacology for RENVELA

US Patents and Regulatory Information for RENVELA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for RENVELA

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

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Paragraph IV (Patent) Challenges for RENVELA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Powder for Oral Suspension 0.8 g/packet and 2.4 g/packet ➤ Subscribe 2009-12-30
➤ Subscribe Tablets 800 mg ➤ Subscribe 2008-12-04

Non-Orange Book US Patents for RENVELA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,895,315 Aliphatic amine polymer salts for tableting ➤ Sign Up
9,585,911 Sachet formulation for amine polymers ➤ Sign Up
8,808,738 Aliphatic amine polymer salts for tableting ➤ Sign Up
9,555,056 Aliphatic amine polymer salts for tableting ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for RENVELA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2002 Austria ➤ Sign Up PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606/01 Switzerland ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
C/GB02/011 United Kingdom ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
00080 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Covington
US Army
Accenture
Deloitte
Cerilliant
UBS
Cantor Fitzgerald

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