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Last Updated: January 16, 2021

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RENVELA Drug Profile

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Which patents cover Renvela, and what generic alternatives are available?

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

This drug has fifty-five 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. Additional details are available on the sevelamer carbonate profile page.

US ANDA Litigation and Generic Entry Outlook for Renvela

A generic version of RENVELA was approved as sevelamer carbonate by AUROBINDO PHARMA LTD on June 13th, 2017.

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Drug patent expirations by year for RENVELA
Drug Prices for RENVELA

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Drug Sales Revenue Trends for RENVELA

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Recent Clinical Trials for RENVELA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Sinomune Pharmaceutical Co., LtdPhase 3
Vifor Fresenius Medical Care Renal PharmaPhase 3

See all RENVELA clinical trials

Paragraph IV (Patent) Challenges for RENVELA
Tradename Dosage Ingredient NDA Submissiondate
RENVELA FOR SUSPENSION;ORAL sevelamer carbonate 022318 2009-12-30
RENVELA TABLET;ORAL sevelamer carbonate 022127 2008-12-04

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   Start Trial   Start Trial Y   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for RENVELA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   Start Trial   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RENVELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 91629 Luxembourg   Start Trial 91629, EXPIRES: 20190810
0716606 C300080 Netherlands   Start Trial 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 SPC004/2002 Ireland   Start Trial SPC004/2002, 20040614, EXPIRES: 20150127
0716606 49/2009 Austria   Start Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606 CA 2009 00048 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
AstraZeneca
Colorcon
Johnson and Johnson
Dow

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