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Last Updated: November 10, 2024

RENAGEL Drug Patent Profile


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When do Renagel patents expire, and what generic alternatives are available?

Renagel is a drug marketed by Genzyme and is included in two NDAs.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Renagel

A generic version of RENAGEL was approved as sevelamer hydrochloride by GLENMARK PHARMS LTD on February 8th, 2019.

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Drug patent expirations by year for RENAGEL
Drug Prices for RENAGEL

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Drug Sales Revenue Trends for RENAGEL

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Recent Clinical Trials for RENAGEL

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SponsorPhase
Medical Universtity of LodzPhase 4
Medical University of LodzPhase 4
ShirePhase 4

See all RENAGEL clinical trials

Paragraph IV (Patent) Challenges for RENAGEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RENAGEL Tablets sevelamer hydrochloride 400 mg and 800 mg 021179 1 2008-05-22

US Patents and Regulatory Information for RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 RENAGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride CAPSULE;ORAL 020926-001 Oct 30, 1998 ⤷  Sign Up ⤷  Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for RENAGEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Genzyme Europe BV Tasermity sevelamer hydrochloride EMEA/H/C/003968
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.,
Withdrawn no no no 2015-02-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RENAGEL

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

Country Patent Number Title Estimated Expiration
Spain 2161780 ⤷  Sign Up
Australia 689797 ⤷  Sign Up
Canada 2402590 ⤷  Sign Up
Denmark 1133989 ⤷  Sign Up
Netherlands 300080 ⤷  Sign Up
Netherlands 300428 ⤷  Sign Up
European Patent Office 0716606 POLYMERES FIXANT LES PHOSPHATES POUR ADMINISTRATION ORALE (PHOSPHATE-BINDING POLYMERS FOR ORAL ADMINISTRATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RENAGEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 91629 Luxembourg ⤷  Sign Up 91629, EXPIRES: 20190810
0716606 C00716606/01 Switzerland ⤷  Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606 6/2002 Austria ⤷  Sign Up PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606 CA 2009 00048 Denmark ⤷  Sign Up
0716606 SPC/GB02/011 200210 United Kingdom ⤷  Sign Up
0716606 C300428 Netherlands ⤷  Sign Up PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606 02C0011 France ⤷  Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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