Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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RENAGEL Drug Profile

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When do Renagel patents expire, and when can generic versions of Renagel launch?

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. Seven suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

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
Collaborative Study Group (CSG)Phase 3

See all RENAGEL clinical trials

Recent Litigation for RENAGEL

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District Court Litigation
Case NameDate
Amgen Inc. v. Accord Healthcare, Inc.2018-06-28
Genzyme Corporation v. Endo Pharmaceuticals Inc.2011-04-27
Genzyme Corporation v. Lupin Ltd.2010-07-14

See all RENAGEL litigation

Pharmacology for RENAGEL
Synonyms for RENAGEL
(C3H7N)m.(C3H5ClO)n.(HCl)x
152751-57-0
182683-00-7
198343-01-0
2-(chloromethyl)oxirane; prop-2-en-1-amine; hydrochloride
2-Propen-1-amine polymer with (chloromethyl)oxirane hydrochloride
2-Propen-1-amine, hydrochloride, polymer with (chloromethyl)oxirane
2-propen-1-amine,hydrochloride,polymer with (chloromethyl)oxirane
AB01568265_01
AC-2089
AC1L4LHX
AC1Q3UBQ
AKOS025149504
Allylamine hydrochloride - epichlorhydrin copolymer
AN-14277
BC226808
BCP21176
CHEBI:32127
CTK4E2490
D01983
FT-0653684
GLS2PGI8QG
GT 16-026A
GT16-026A
HS-0082
KHNXRSIBRKBJDI-UHFFFAOYSA-N
LS-181811
MolPort-005-943-544
MolPort-039-138-690
Oxirane, (chloromethyl)-, polymer with 2-propen-1-amine hydrochloride
PB 94
Phosblock
prop-2-en-1-amine- 2-(chloromethyl)oxirane hydrochloride(1:1:1)
Renestat
s4129
Sevelamer HCl
Sevelamer hydrochloride
Sevelamer hydrochloride (JAN/USAN)
Sevelamer hydrochloride [USAN]
SEVELAMERHCL
UNII-GLS2PGI8QG
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 021179-002 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 CAPSULE;ORAL 020926-001 Oct 30, 1998   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 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 C300428 Netherlands   Start Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
0716606 49/2009 Austria   Start Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606 SPC/GB02/011 United Kingdom   Start Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
0716606 02C0011 France   Start Trial PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
0716606 C300080 Netherlands   Start 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 6/2002 Austria   Start Trial PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606 C00716606/01 Switzerland   Start Trial PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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