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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Teva
US Army
Colorcon
McKesson
Moodys
Fish and Richardson
Citi

Generated: June 19, 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.

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 022318-001 Aug 12, 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 022318-002 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
9,585,911 Sachet formulation for amine polymers ➤ Sign Up
8,808,738 Aliphatic amine polymer salts for tableting ➤ Sign Up
9,895,315 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
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
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606/01 Switzerland ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
/2009 Austria ➤ Sign Up PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Johnson and Johnson
Cantor Fitzgerald
Mallinckrodt
Harvard Business School
Cerilliant
AstraZeneca
Daiichi Sankyo

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