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Last Updated: October 26, 2020

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renagel Drug Profile

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

Renagel is a drug marketed by Genzyme and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-one patent family members in thirty-one countries.

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

US ANDA 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
Keryx BiopharmaceuticalsPhase 3

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Pharmacology for renagel
Paragraph IV (Patent) Challenges for RENAGEL
Tradename Dosage Ingredient NDA Submissiondate
RENAGEL TABLET;ORAL sevelamer hydrochloride 021179 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   Start Trial   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 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 renagel

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

Supplementary Protection Certificates for renagel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 SPC004/2002 Ireland   Start Trial SPC004/2002, 20040614, EXPIRES: 20150127
0716606 91629 Luxembourg   Start Trial 91629, EXPIRES: 20190810
0716606 SPC/GB02/011 United Kingdom   Start Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
0716606 49/2009 Austria   Start Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606 C00716606/01 Switzerland   Start Trial PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
0716606 SPC/GB02/011 200210 United Kingdom   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Dow

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