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Last Updated: February 2, 2023

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-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. Twenty-nine suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

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
Steno Diabetes Center CopenhagenN/A

See all RENVELA clinical trials

Pharmacology for RENVELA
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sachet formulation for amine polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 See Plans and Pricing See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 See Plans and Pricing See Plans and Pricing
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 See Plans and Pricing See Plans and Pricing
>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
Genzyme Europe BV 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
Genzyme Europe BV 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

Supplementary Protection Certificates for RENVELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 02C0011 France See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606 6/2002 Austria See Plans and Pricing PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606 CA 2002 00003 Denmark See Plans and Pricing
0716606 91629 Luxembourg See Plans and Pricing 91629, EXPIRES: 20190810
>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.