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Last Updated: January 21, 2020

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SEVELAMER CARBONATE - Generic Drug Details

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What are the generic drug sources for sevelamer carbonate and what is the scope of freedom to operate?

Sevelamer carbonate is the generic ingredient in two branded drugs marketed by Genzyme, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sanofi, Amneal Pharms Co, Impax Labs Inc, Invagen Pharms, Twi Pharms, and Wilshire Pharms Inc, and is included in eleven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sevelamer carbonate has fifty-five patent family members in twenty-one countries.

There are thirty-two drug master file entries for sevelamer carbonate. Nineteen suppliers are listed for this compound.

Drug Prices for SEVELAMER CARBONATE

See drug prices for SEVELAMER CARBONATE

Recent Clinical Trials for SEVELAMER CARBONATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shandong Weigao Panion Pharmaceutical Co. Ltd.Phase 3
Panion & BF Biotech Inc.Phase 3
ArdelyxPhase 4

See all SEVELAMER CARBONATE clinical trials

Recent Litigation for SEVELAMER CARBONATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Genzyme Corporation v. Endo Pharmaceuticals Inc.2011-04-27
Genzyme Corporation v. Lupin Ltd.2010-07-14
Genzyme Corporation v. Sandoz, Inc.2009-07-02

See all SEVELAMER CARBONATE litigation

Pharmacology for SEVELAMER CARBONATE
Synonyms for SEVELAMER CARBONATE
2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate
845273-93-0
9YCX42I8IU
AN-9605
Carbonic acid, compd. with (chloromethyl)oxirane polymer with 2-propen-1-amine
carbonic acid; 2-(chloromethyl)oxirane; prop-2-en-1-amine
GT 335-012
HS-0081
KS-00002WUH
MolPort-035-869-714
Prop-2-en-1-amine polymer with (Chloromethyl)oxirane carbonate
Renvela
SC-24770
Sevelamer carbonate [USAN]
UNII-9YCX42I8IU
Paragraph IV (Patent) Challenges for SEVELAMER CARBONATE
Tradename Dosage Ingredient NDA Submissiondate
RENVELA FOR SUSPENSION;ORAL sevelamer carbonate 022318 2009-12-30
RENVELA TABLET;ORAL sevelamer carbonate 022127 2008-12-04

US Patents and Regulatory Information for SEVELAMER CARBONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207179-001 Jul 17, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wilshire Pharms Inc SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 204451-001 Nov 29, 2018 AB RX No No   Start Trial   Start Trial   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 SEVELAMER CARBONATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   Start Trial   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SEVELAMER CARBONATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716606 C00716606/01 Switzerland   Start Trial PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
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 C300428 Netherlands   Start Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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