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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
US Army
Merck
UBS
Citi
Covington
Federal Trade Commission
Cerilliant
Colorcon

Generated: August 17, 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 and Aurobindo Pharma Ltd, and is included in three 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 forty-one patent family members in twenty countries.

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

Summary for Generic Name: sevelamer carbonate

Tradenames:2
Patents:2
Applicants:2
NDAs:3
Drug Master File Entries: see list32
Suppliers / Packagers: see list8
Clinical Trials: see list197
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sevelamer carbonate at DailyMed

Pharmacology for Ingredient: 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
FOR SUSPENSION;ORAL207624-002Jun 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007RXYesYes► 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
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 2009► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 2007► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 2009► Subscribe► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 2009► 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
8,808,738Aliphatic amine polymer salts for tableting► Subscribe
9,555,056Aliphatic 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
Japan5307398► Subscribe
Canada2762076► Subscribe
Mexico2007004939► Subscribe
Japan5922184► Subscribe
Japan5758945► 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
/2009Austria► SubscribePRODUCT NAME: SEVELAMERCARBONAT; REGISTRATION NO/DATE: EU/1/09/521/001- EU/1/09/521/007 20090610
0716606/01Switzerland► SubscribePRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
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
00428Netherlands► SubscribePRODUCT NAME: SEVELAMER CARBONAAT OF BICARBONAAT; REGISTRATION NO/DATE: EU/1/09/521/001-007 20090610
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Fuji
US Army
Federal Trade Commission
Cerilliant
Moodys
Deloitte
QuintilesIMS
Cantor Fitzgerald
Argus Health

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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