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Last Updated: September 25, 2022

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. Five 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
ShirePhase 4
Medical Universtity of LodzPhase 4
Medical University of LodzPhase 4

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Pharmacology for RENAGEL
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing 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 RENAGEL

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
Malaysia 125495 DIRECT COMPRESSION POLYMER TABLET CORE See Plans and Pricing
Brazil PI0015061 comprimido revestido tendo alta dosagem de cloridrato de sevelamer See Plans and Pricing
Turkey 200201087 See Plans and Pricing
Japan 2016000753 直接圧縮ポリマー錠剤コア (DIRECT COMPRESSION POLYMER TABLET CORE) See Plans and Pricing
European Patent Office 1133989 Polymère à utilisation thérapeutique (Polymer compositions for use in therapy) See Plans and Pricing
South Africa 200202772 Direct compression polymer tablet core. See Plans and Pricing
Portugal 1239837 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RENAGEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 C300080 Netherlands See Plans and Pricing 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 C00716606/01 Switzerland See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606 02C0011 France See Plans and Pricing PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606 91629 Luxembourg See Plans and Pricing 91629, EXPIRES: 20190810
0716606 SPC/GB02/011 200210 United Kingdom See Plans and Pricing
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 49/2009 Austria See Plans and Pricing 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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