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Last Updated: April 22, 2024

RENVELA Drug Patent 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-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Renvela

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

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Summary for RENVELA
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

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SponsorPhase
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Sinomune Pharmaceutical Co., LtdPhase 3
SanofiN/A

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Pharmacology for RENVELA
Drug ClassPhosphate Binder
Mechanism of ActionPhosphate Chelating Activity
Paragraph IV (Patent) Challenges for RENVELA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RENVELA Powder for Oral Suspension sevelamer carbonate 0.8 g/packet and 2.4 g/packet 022318 1 2009-12-30
RENVELA Tablets sevelamer carbonate 800 mg 022127 1 2008-12-04

US Patents and Regulatory Information for RENVELA

RENVELA is protected by two US patents.

Patents protecting RENVELA

Aliphatic amine polymer salts for tableting
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sachet formulation for amine polymers
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for RENVELA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi B.V. Renvela sevelamer carbonate EMEA/H/C/000993
Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.
Authorised no no no 2009-06-09
Sanofi B.V. Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) sevelamer carbonate EMEA/H/C/003971
Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/L.Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Authorised no no no 2015-01-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RENVELA

See the table below for patents covering RENVELA around the world.

Country Patent Number Title Estimated Expiration
New Zealand 309548 Use of phosphate-binding polymers for oral administration ⤷  Try a Trial
Croatia P20170505 ⤷  Try a Trial
European Patent Office 1676581 ⤷  Try a Trial
Japan 2016047849 アミンポリマー用サシェ製剤 (SACHET FORMULATION FOR AMINE POLYMERS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RENVELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 C300080 Netherlands ⤷  Try a 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 CA 2002 00003 Denmark ⤷  Try a Trial
0716606 CA 2009 00048 Denmark ⤷  Try a Trial
0716606 49/2009 Austria ⤷  Try a Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.