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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
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Chinese Patent Office
Covington
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US Department of Justice
Healthtrust
Johnson and Johnson
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Generated: December 18, 2017

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Sevelamer carbonate - Generic Drug Details

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What are the generic 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, Impax Labs Inc, and Invagen Pharms, and is included in seven 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 patent family members in twenty-one countries and seven supplementary protection certificates in five countries.

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

Pharmacology 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 LtdSEVELAMER CARBONATEsevelamer carbonateTABLET;ORAL206094-001Sep 29, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Impax Labs IncSEVELAMER CARBONATEsevelamer carbonateTABLET;ORAL090975-001Oct 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen PharmsSEVELAMER CARBONATEsevelamer carbonateTABLET;ORAL203860-001Oct 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdSEVELAMER CARBONATEsevelamer carbonateTABLET;ORAL207179-001Jul 17, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdSEVELAMER CARBONATEsevelamer carbonateFOR SUSPENSION;ORAL207624-002Jun 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007ABRXYesYes► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma LtdSEVELAMER CARBONATEsevelamer carbonateFOR SUSPENSION;ORAL207624-001Jun 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sevelamer carbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateFOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
GenzymeRENVELAsevelamer carbonateTABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,585,911Sachet formulation for amine polymers► Subscribe
9,555,056Aliphatic amine polymer salts for tableting► Subscribe
8,808,738Aliphatic amine polymer salts for tableting► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: sevelamer carbonate

Country Document Number Estimated Expiration
European Patent Office3000460► Subscribe
Japan2008518950► Subscribe
Japan5307398► Subscribe
Portugal1924246► Subscribe
Israel189967► Subscribe
BrazilPI0616078► Subscribe
China102824322► Subscribe
Japan2009508580► Subscribe
Japan6029736► Subscribe
Spain2556217► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SEVELAMER CARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/011United Kingdom► SubscribePRODUCT NAME: SEVELAMER; REGISTERED: UK EU/1/99/120/001-004 20000202
00080Netherlands► SubscribePRODUCT 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
/2009Austria► SubscribePRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
00428Netherlands► SubscribePRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
C0011France► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NO/DATE: EU/1/99/123/001 20000128
2002Austria► SubscribePRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606/01Switzerland► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
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Serving leading biopharmaceutical companies globally:

Deloitte
McKesson
Teva
QuintilesIMS
Queensland Health
Healthtrust
Chinese Patent Office
McKinsey
Harvard Business School
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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