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Generated: January 18, 2019

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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 sevelamer carbonate 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-two patent family members in twenty-one countries.

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

Pharmacology for SEVELAMER CARBONATE
Synonyms for SEVELAMER CARBONATE
2-Propen-1-amine polymer with (chloromethyl)oxirane carbonate
845273-93-0
9YCX42I8IU
ALLYLAMINE; CARBONIC ACID; EPICHLOROHYDRIN
AN-9605
Carbonic acid, compd. with (chloromethyl)oxirane polymer with 2-propen-1-amine
carbonic acid; 2-(chloromethyl)oxirane; prop-2-en-1-amine
D0G7XO
GT 335-012
GT-335-012
HE045749
HS-0081
KS-00002WUH
MolPort-035-869-714
Prop-2-en-1-amine polymer with (Chloromethyl)oxirane carbonate
Renvela
Renvela (powder formulation), Genzyme
SC-24770
Second generation sevelamer, Genzyme
Sevelamer carbonate (powder formulation, renal disease/hyperphosphatemia), Genzyme
Sevelamer carbonate (tablet, renal disease/hyperphosphatemia), Genzyme
Sevelamer carbonate [USAN]
Sevelamer carbonate tablet
UNII-9YCX42I8IU

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
Dr Reddys Labs Ltd SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 206094-001 Sep 29, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs Inc SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 090975-001 Oct 23, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Wilshire Pharms Inc SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 204451-001 Nov 29, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Invagen Pharms SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 203860-001 Oct 26, 2017 AB RX No No ➤ 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

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

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Supplementary Protection Certificates for SEVELAMER CARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/011 United Kingdom ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
00080 Netherlands ➤ Sign Up 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
0716606/01 Switzerland ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
C0011 France ➤ Sign Up PRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
00428 Netherlands ➤ Sign Up PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
/2009 Austria ➤ Sign Up PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Johnson and Johnson
US Army
McKesson
Dow
Accenture
US Department of Justice
Federal Trade Commission

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