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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Merck
Boehringer Ingelheim
Fish and Richardson
Daiichi Sankyo
Federal Trade Commission
UBS
Johnson and Johnson
Mallinckrodt

Generated: January 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 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. Seventeen suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for RENVELA
International Patents:50
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 7
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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 ➤ Subscribe ➤ Subscribe
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Subscribe ➤ Subscribe
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 12/30/2009
➤ Subscribe Tablets 800 mg ➤ Subscribe 12/4/2008

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

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International Patents for RENVELA

Supplementary Protection Certificates for RENVELA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/011 United Kingdom ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
C0011 France ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
00428 Netherlands ➤ Subscribe PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
/2009 Austria ➤ Subscribe PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
2002 Austria ➤ Subscribe PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
00080 Netherlands ➤ Subscribe 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
0716606/01 Switzerland ➤ Subscribe PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Fuji
Covington
Novartis
Johnson and Johnson
Express Scripts
Chubb
Mallinckrodt
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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