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Last Updated: March 9, 2021

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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, Impax, Sanofi, Amneal Pharms Co, Anxin, Impax Labs Inc, Invagen Pharms, Mylan, Rising, Twi Pharms, and Zydus Pharms, and is included in fifteen 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. Twenty suppliers are listed for this compound.

Summary for sevelamer carbonate
International Patents:55
US Patents:2
Tradenames:2
Applicants:13
NDAs:15
Drug Master File Entries: 32
Suppliers / Packagers: 20
Bulk Api Vendors: 16
Clinical Trials: 50
Formulation / Manufacturing:see details
Drug Prices: Drug price trends for sevelamer carbonate
What excipients (inactive ingredients) are in sevelamer carbonate?sevelamer carbonate excipients list
DailyMed Link:sevelamer carbonate at DailyMed
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
Shanghai Alebund Pharmaceuticals LimitedPhase 2
Akebia TherapeuticsPhase 1
Panion & BF Biotech Inc.Phase 3

See all sevelamer carbonate clinical trials

Pharmacology for sevelamer carbonate
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
Dr Reddys Labs Ltd SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 206094-001 Sep 29, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 203860-001 Oct 26, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207288-001 Nov 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Anxin SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 212970-001 Apr 9, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207759-001 Aug 11, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 090975-001 Oct 23, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207179-001 Jul 17, 2017 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
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007   Start Trial   Start Trial
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-001 Aug 12, 2009   Start Trial   Start Trial
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
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
Genzyme RENVELA sevelamer carbonate FOR SUSPENSION;ORAL 022318-002 Feb 18, 2009   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 49/2009 Austria   Start Trial PRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
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 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 C300428 Netherlands   Start Trial PRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
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 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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