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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Colorcon
Boehringer Ingelheim
Accenture
UBS
Covington
McKinsey
Queensland Health
US Department of Justice

Generated: August 19, 2018

DrugPatentWatch Database Preview

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, Amneal Pharms Co, Dr Reddys Labs Ltd, Impax Labs Inc, Invagen Pharms, and Sandoz Inc, and is included in nine 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-one 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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Invagen Pharms SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 203860-001 Oct 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for SEVELAMER CARBONATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,585,911 Sachet formulation for amine polymers ➤ Try a Free Trial
8,808,738 Aliphatic amine polymer salts for tableting ➤ Try a Free Trial
9,555,056 Aliphatic amine polymer salts for tableting ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SEVELAMER CARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00428 Netherlands ➤ Try a Free Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
C/GB02/011 United Kingdom ➤ Try a Free Trial PRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
2002 Austria ➤ Try a Free Trial 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:

Daiichi Sankyo
Colorcon
Mallinckrodt
Fish and Richardson
Johnson and Johnson
Cipla
UBS
Cerilliant
Cantor Fitzgerald

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